Fulgent Genetics, Inc. (FLGT)
NASDAQ: FLGT · Real-Time Price · USD
15.01
+0.09 (0.60%)
May 7, 2026, 2:22 PM EDT - Market open
← View all transcripts

UBS Global Healthcare Conference 2024

Nov 12, 2024

Speaker 5

Like stuff dreams are made of.

Speaker 6

Really?

It was one of our pilot quarters.

Speaker 4

Great. So we are live now. Well, thank you so much for joining us today. And we're very pleased to welcome the team for Fulgent Genetics. Joining me today are Brandon Perthuis, Chief Commercial Officer, Paul Kim, CFO, and then we have Dr. Ray Yin, President and Chief Scientific Officer. Well, welcome everybody.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Thank you.

Speaker 4

Great. So before we go into specific business, maybe just give us a little bit quick update, in terms of the key highlights in the Q3 earnings last week.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Yeah, certainly. I think we had a strong quarter, the third quarter. You know, we break our precision diagnostics business down into three areas. I'm sorry, our lab services down into three areas: precision diagnostics, anatomic pathology, and pharma services. So this was the second quarter in a row that all three areas had growth. Precision diagnostics was particularly strong, about 20% sequential growth. We achieved our guidance for Q3. We reiterated our guidance for 2024, which is $280 million. We reiterated our expected cash balance at the end of the year of at least $800 million in cash. Gross margins grinded higher. Yeah, I think it was a pretty solid quarter for the company, and you know, hopefully the momentum carries into Q4 and then on to next year.

Speaker 4

Great. So maybe stepping back a little bit, just talk about, like, more high level. The business has grown quite a lot from, like, $21 million in 2018 to, like, $200 million in 2024, which is your guide. So maybe tell us a little bit about, like, what's the drivers, right? And then also in terms of, like, the your ability of catching it, the NGS opportunity, both in Heme and in Solid. Maybe just talk a little bit about the core selling opportunities. Yeah.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Yeah, certainly. I mean, it's been quite the growth story. I mean, $21 million-$280 million guide, as you've mentioned it. You know, first, I'd like to really, you know, acknowledge, you know, the technology of the company. You know, to scale that rapidly is not trivial, and we've talked a lot about our tech platform since we've gone public. And, you know, here recently, and even during COVID, you know, we really got the opportunity to stress test that technology platform. So, you know, we're talking about things like, you know, our own LIMS, our own bioinformatics, proprietary algorithms, proprietary pipelines, variant calling tools. You know, that sort of is the foundation on which we built the company on.

So, you know, when we went public in 2016, you know, we're pretty much a niche, rare disease, you know, pediatric company. And if you fast forward to today, you know, we have a menu of 22,000 different genetic tests, you know, essentially spanning all areas of genomic healthcare from prenatal services, reproductive services, rare disease, oncology, both somatic and hereditary, you know, adult genetics. It's been really an impressive, you know, growth story, the test menu. And that's led to the opportunities that we've had. So we've, you know, broken out of the niche rare disease market into these different areas of genomic healthcare. We've done a good job capturing market share in all those areas. Now, the growth wasn't entirely organic. We did do a couple acquisitions. You know, we bought Inform Diagnostics and a great anatomic pathology laboratory.

We bought CSI Laboratories, a cancer diagnostics laboratory, so it's been a, you know, a mix of both M&A, and organic growth, but the company's done well capturing market share. You know, lately, we've done really well in reproductive health as well as hereditary cancer. You know, we've made some announcements in the quarter, this quarter about the new award and contract we won with the VA Hospital, which is hereditary cancer. That was a $99 million contract, up to $99 million over the next five years, so I think, you know, the diversification of our test menu, has really expanded our addressable market, and now we're doing a good job penetrating it.

Speaker 4

Great. So you mentioned multiple times about share gain. Maybe can you share a little bit more successful examples? And we know that there are lots of, like, disruption in the past few years, right? So several players exited in the market. Do you think the market has stabilized at this point?

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Yeah, that's a good question. I mean, we sort of watched all that happen around us, right? We sort of stuck to our game plan and executed our plan and watched that happen around us, and you know, in several instances, it's been beneficial to Fulgent, right? As some of our peers and competitors have exited this marketplace, you know, Fulgent stepped in and has taken significant share in those markets, especially in reproductive health and women's health, along the lines of expanded carrier screening. Some of the consolidation we've seen there and some of the demise we've seen there, you know, Fulgent's been able to step up and take some of that market share. You know, one of the things we're really proud of is, you know, controlling our cost structure.

Some of that is a testament to our technology platform, and, you know, other areas of just us controlling our costs and operating our business. So we're able to, you know, operate a laboratory with, we think, some of the best in class cost structure. So we're able to take some of that market share, have good gross margins on that business. So we're in continuous disruption. I mean, just a few weeks ago, or maybe last week, there was another big acquisition in the space. So and there's been other labs that have exited the space. And I think, you know, each time that happens, it's been beneficial to our company. We've been sort of the rock. We've been steady. Clients see that, right? Clients want stability. They want a lab they can trust, good turnaround time, good quality, good service.

That's what we've been. So we're continuing to win new clients, and I think that's gonna continue.

Speaker 4

Okay. So I assume that will continue in 2025 and then.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Yeah. When that's certainly the plan, right?

Speaker 4

Yeah.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

You know, I’ve mentioned a few times that, you know, our lab is pretty much where we want it to be, you know, in terms of capabilities, in terms of our test menu, our turnaround time, our quality, our insurance contracts, you know, our MolDX approvals, which we’re really proud of. So I think, you know, we kinda got the operation where we want it to be. But our sales team is still subscale. I think we need to continue to build out a larger sales team. We did a little bit of that in 2024, and we saw those investments pay off, right? We’ve recruited some good talent, and that’s beginning to pay off. So I think, you know, as you talk about, you know, what is 2025, does that carry into 2025? I think the short answer is yes.

Continuing to execute operationally, expand the sales team, and continue to gain market share.

Speaker 4

And then talking about the sales team, right? So right now, subscale, and then you want to kind of increase the number of sales. But how long does it actually you need to train them, right? So how long.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Yeah.

Speaker 4

Can you actually see the impact? Like, starting to winning contract, winning new customer, something like that?

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

There's a big window there, right? I mean, some of the salespeople we've hired, and then they hit the ground running. And honestly, we do try to hire experienced salespeople, with relationships, you know, with accounts, with knowledge of the test. And part of Fulgent is we're a complex business, right? We do have a lot of different areas of specialty. So it's not the same sales reps that are selling hereditary cancer that are selling anatomic pathology services. So we do have to build, you know, multiple sales teams to some degree. Now, there is some cross-selling that happens. But some of the reps, you know, we hire specialized reps for the testing we want to grow. So it's like anatomic pathology, for example.

We're out there targeting reps with previous anatomic pathology experience, you know, with accounts, with relationships, with some product knowledge and training, so some of them have hit the ground running quite quickly, to be honest with you, and then some take some time. It could be, you know, sometimes three months before a rep closes their first deal, so a little bit of a window there, but, you know, I think we've also invested in good sales leadership. We've invested in good salespeople in 2024, and, you know, especially on the AP side, 'cause that's probably the area where we're most subscale. I mean, that's a huge market, pretty fractionated market, a lot of call points, and we've been, you know, a pretty lean team there.

I think right now we have maybe, you know, 15 people on the AP sales, and that should be, you know, significantly larger, but we're not gonna rush out there and hire a bunch of people, you know, all at once. We're gonna, you know, slowly ease into it, look for good talent, layer that on. I mean, the good news is the laboratory has the capacity and the scalability. That's, I think, really important. If you look at our AP lab, I mean, our subspecialty trained pathologist, our turnaround time, is fantastic. While the salespeople are wonderful, they, they've hired some really good ones. They're selling a good product, right? I mean, if you look at sticking on the AP for a second, if you look at our AP lab, I mean, it's fantastic.

A lot of our salespeople out there selling, especially on the derm side of the business, they're running into clinicians that are experiencing like two- to three-week turnaround time, frequently, frequently experiencing two- to three-week turnaround time. And right now we're at two or three days, right? So that's huge, right? Patients want results. I mean, this is sometimes a nervous situation for a patient. They wanna know if this is a benign lesion or is this potentially cancer or precancerous. So, you know, if they're waiting two or three weeks, that's not fun. So if we can give them results in two or three days, that's huge for patient care. And clinicians, you know, they wanna know, like, you know, from, you know, taking medically actionable steps, the sooner they can get started, the better.

Like I said, I think we have the foundation of a true world-class sales team, but you know, they really are selling a great product. And I'm really proud of what the lab has done. Now, you know, the AP hasn't been easy, right? We had multiple quarters of headwinds. But Paul and I and the rest of the management team and the middle leadership level, you know, have really been dedicated to turning that around. And I think we have. Like I said, two quarters in a row, we've returned AP to growth. I would say today the pipeline is strong as I've ever seen it. We acquired the company, you know, something like two-plus years ago, but the sales pipeline is incredibly robust. Clients are happy.

So, you know, I think we have good momentum in that area, which, like I said, we didn't always have post-acquisition, but, you know, we were dedicated to fixing the business, and I think we've done that.

Speaker 4

Great. I mean, sticking with the AP then, I mean, as you mentioned, there were a couple quarters of headwinds.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Yeah.

Speaker 4

But starting to get a little bit better. So when we think about 2025, do you think it's gonna be like a bigger comeback, or it's still more like a gradual recovery type of environment?

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

I don't know. It's hard to say, obviously. I don't have a crystal ball, but I have, you know, visibility in the pipeline, the pipelines and the opportunities, and again, it looks pretty robust. You know, I think we did a lot of things with that business, and don't wanna bore the audience with all the details, but, you know, it's been both a focus on the commercial side, you know, improving the sales team, getting the right salespeople in there, the right leadership, you know, little things like, you know, incentive comp plans we had to redo. You know, we inherited a lot through the acquisition, and we needed to change some things to put that, you know, lab back onto a growth trajectory, but also, you know, operations.

I think we mentioned in the quarter, we bought a new building in Coppell, Texas, that allowed us to move out of a building that wasn't ideal. We inherited that building. It wasn't set up ideal. We were able to build this one from the ground up so we could really optimize our workflows, our procedures, and that lab has capacity, is scalable, turnaround times, quality are great. Then we were able to shut down our lab in New York and consolidate that into the AP business. So when I say we sort of turned around the business or fixed the business, it's been both sort of operationally and commercially. So to your question is, you know, what does 2025 look like? You know, I think the pipelines and the sales team, you know, there's enough there to continue that growth trajectory.

If we layer on more salespeople, which is the plan, you know, slowly, I think that's gonna continue to fuel growth as well.

Speaker 4

Great. So let's switch to the more precision diagnostic. So carrier screening is a big part of your portfolio right now.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Yes.

Speaker 4

How big is that? And then, how do you think about 2025? You mentioned there was some, M&A happening.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Mm-hmm.

Speaker 4

In the past few weeks. Like, how do you think about that dynamic? Yeah, just a little bit more color.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Right. So we don't break out any sort of volume or revenue by specific tests, right? We break it out into three categories: precision diagnostics, anatomic pathology, and pharma services. So carrier screening would be in the precision diagnostics bucket. So while we don't break it out, I think it's safe to say it's our highest volume test within the company. You know, we did do a good job capturing market share when certain players exited that space. You know, that was a dynamic time, right? You had a pretty big player exit the space and sort of put physicians in a bit of turmoil. They had to run out and find a new lab pretty quickly. And a lot of them found a home with Fulgent, but a lot didn't. And there's obviously other players out there.

But we're continuing to go after the business that we didn't win sort of initially, right? And clinicians are appreciating Fulgent in terms of carrier screening has really been our turnaround time, our quality, our integrations, and our ability to customize the panel. Now, that sounds trivial, but it certainly is not trivial. To build genetic testing panels, you know, can often take months in other organizations. We can build custom genetic testing panels in hours, right? So a clinician can come to Fulgent, custom design a genetic testing panel today, and it's orderable tonight. They can send a sample tomorrow. And that's important 'cause there are some clinicians that have very specific requirements on what sort of panel they want, how big they want, what genes they want.

Speaker 4

Mm-hmm.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

So I think we, you know, we have what it takes in the carrier screening market. You know, our, our brand is Beacon. We have the Beacon Expanded Carrier Screening, but it's not just one test. It's a suite of tests. You know, it ranges from two or three genes all the way up to 787 genes, which is the largest gene panel on the market right now, I believe. So I think, you know, we've done a great job in carrier screening. And it, you know, that market, I think, is going to continue to grow. I think more and more clinicians are gravitating towards expanded carrier screening. I think the days of running cystic fibrosis and SMA and, you know, Duchenne muscular dystrophy may be running, you know, two or three genes. I think those days are pretty much coming to an end.

I think the technology exists today to offer larger panels. We can do it as rapidly as we can the small panels, and while some of the, you know, as you get into 787 genes, you know, these genetic conditions become rarer. They can become, you know, rare, but, you know, collectively, they're not rare, right? So you know, if a couple is planning a pregnancy or is currently pregnant and we can test for these things to give them valuable information on their future or current pregnancy, we should do that, right, so I mean, you know, it takes both couples to be a carrier of the same condition, right? But if both couples are carrier of the same condition, they have a 25% chance of having an affected child. I think that's valuable information that couples should know.

Speaker 4

When you talk about the large panel versus small panel, do you know the mix right now? Like, is it more than 50% in large panel versus like a little bit less in small panel?

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

I can only speak for Fulgent, and I'm qualifying that because a lot of our business today, a lion's share of our business today is in the infertility market.

Speaker 4

Mm-hmm.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

We're not much in the , but I wanna talk about that in a second 'cause I wanna talk about, you know, our new NIPT test, but a lion's share of our business is in the infertility clinic, so these are couples trying to get pregnant. In that market segment, it's almost always the big panel, right? Because the couple's not pregnant yet, right, so they have an opportunity to test for as much as they can to give the couple, you know, the lowest, you know, risk result possible, and then if we do detect something, the couple has immediate options, right? They can do PGD. They can identify the embryos. They can identify the 25% of embryos that have that condition, not implant those embryos, so it's immediately medically actionable, so most REIs, infertility doctors, are opting to the big panel.

That's most of our business. So almost everything we do today is the very big panel.

Speaker 4

You talk about , and then.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Yeah.

Speaker 4

Probably NIPT will be the next, good topic. So you're a little bit late, in that market.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

A little bit. Just a little bit.

Speaker 4

Just a little bit. Exactly. So maybe talk about why and then how do you think about scaling that business?

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Yeah. Yeah, that's a good question. So again, I'm proud of our execution in the IVF space. We've done a really good job to penetrate the OB/GYN space with carrier screening, you need NIPT. So we have a great carrier screening product. But if you go to an OB/GYN, they want to order NIPT and carrier screening together. And if you don't have both, you're not gonna be successful. So yeah, we're a little bit late. I don't know, decade or more late to the game. But we knew that launching a Me Too product, just a standard NIPT, we didn't stand a chance, right? I mean, there's a lot of really great labs out there doing NIPT that have had this business for a very long time. I applaud them. They've done a great job.

They've brought the technology a long, long way over the last 10 years. So we said that if we could ever launch a novel NIPT, you know, something differentiated, that we'd have interest in doing that. And we did. So we launched what we've branded KNOVA. It is a novel NIPT. So it does the traditional aneuploidy screening. It has microdeletions and microduplications, more than what's currently on the market. But the real differentiator, the real value add, are the de novo point mutations. So we have sort of the only, you know, one test NIPT that includes the de novo point mutations. And, you know, de novo point mutations are important. They're very important. They're hard to do. They're not easy to do, but they're important. A lot of these de novo point mutations cause severe disability.

They cause a lot, you know. They cause significant problems, and there's no indication for testing, right? There's no ultrasound markers. There's no increased nuchal translucency marker. There's no family history. They're de novo. They're spontaneous events. There is no family history, so our tests can detect those things reliably with good sensitivity and specificity, and it kinda goes back to what I was saying about carrier screening. If the technology exists to look for more and it's not, you know, wildly more expensive or wildly slower in terms of turnaround time, you know, I think we should give patients the option, so you know, look, I think it's going to be slow for us to grow that NIPT. I mean, it's a novel test into an established market, so I think it's going to take time.

But at least in our soft launch and we started selling in September, at least in that timeframe, the message seems to be, you know, resonating with clinicians. Most of them, you know, understand what these de novo point mutations are, but because no test has, you know, detected them before, it's still new to them. But I think it's resonating. So I think over time, KNOVA will do well. And back to the original point, now that we have a great carrier screening test in NIPT, you know, we're optimistic we can now go penetrate the OB/GYN market.

Speaker 4

Got it. I think the next logical question will be the ACOG guideline. Do you need the guideline inclusion to kind of like move the product into the next stage?

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

For de novo point mutations?

Speaker 4

I guess like for Expanded Carrier Screening and then like.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Expanded carrier screening. Right. So, it certainly helps, no doubt. But you know, ACOG, big organization, busy organization. I certainly don't fault them at all. But like, expanded carrier screening is pretty much standard of care today, right? I mean, most infertility clinics in this country are ordering expanded carrier screening. So we're living in a time where, you know, how clinicians are practicing medicine are a little bit ahead of the guidelines. And I, you know, Fulgent, as well as some of our peers, we're working together. Fulgent and our peers are working together to help move those guidelines along. We're all part of a consortium for carrier screening, promoting expanded carrier screening, expanding access to carrier screening.

I think in the, you know, not too distant future, you know, we'll see a more robust ACOG guideline around expanded carrier screening. That's not gonna change adoption too much because mostly standard of care today. It might change it more on the OB/GYN space, but the REI space, I think, is a little bit ahead of that curve. Expanded guidelines from ACOG and other societies like that, it does help with reimbursement, for example, right? There are some payers out there that still consider expanded carrier screening investigational, experimental, or unproven. Thus, they may not pay for it. Those guidelines certainly help in that area. Again, I think they're coming from what we can tell.

Speaker 4

Got it. And then on hereditary cancer front, you mentioned about the VA contract.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Mm-hmm.

Speaker 4

$90 million-$99 million over five years.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Right.

Speaker 4

But you need to go and hunt the volume.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

That's right. Yeah.

Speaker 4

You also mentioned they're gonna be a significant contributor in 2025.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Mm-hmm.

Speaker 4

Maybe just tell us a little bit about how do you want it to start in that? Is it all incremental or?

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

It is all incremental. It's a new win. So I know there's a little bit of confusion. And in our call, you know, we mentioned we work with the VA for a long time, which we're proud of. And then we talked about this new contract. So I think there was some confusion like, oh, is this business they already had? No, this is new business. This is organic business. And you know, I think when I look at the VA contract, I think it's a true validation of our company, right? So there was a lot of competition for that award. There's a lot of great labs out there that do expanded hereditary cancer testing. So we don't know who all submitted for that award, but we know it was a lot of labs, and they chose Fulgent, right?

They could have chosen someone else, but they chose Fulgent. And I think it's a validation of our company. You know, why did they choose Fulgent? They don't really tell us, but we know what we sold on, right? Our turnaround time, our quality, our informatics, you know, how we handle the difficult areas of the genome. We do have proprietary algorithms and misalignment tools and variant calling tools that are proprietary to Fulgent. So maybe 99% of the genome is pretty easy to address, right? It's pretty straightforward. But there's, you know, 1% of the genome that's really hard to interpret, pseudogenes and things like that. And we take it to that next level and do a good job with the 1%. Those numbers aren't, you know, it's not truly 1%, but you kinda get the point.

So, you know, we're happy to win that award. We're honored to win that award. And it is a hunting license. You're right. So now it's, like I said, up to $99 million over five years. What that means is now our team can go to the hospitals, let them know, hey, we won the award. We're your approved vendor. We need to set them up as a customer, right? Gotta get them on our portal and get them our kits and tubes and FedEx things, just logistics, right? But we believe the demand is there, right? I mean, we believe the demand is there. And the guidelines have moved that way. You know, there was also another RFP for the solid tumor part of the business. We didn't win that. We applied for it. Didn't win. We don't win everything.

But another great lab won the solid tumor. And I think what you're seeing and we won the hereditary. And what you're seeing today from the medical guidelines is what they're saying is patients with cancer, you should do solid tumor and hereditary. So you got two great labs that are serving the VA now, one doing the solid tumor, Fulgent doing the hereditary cancer. So we believe the tests are in high demand. Our team needs to get out there, set up those accounts, get that volume rolling. It's hard to say how much revenue we'll recognize next year 'cause we just won this, right? We hadn't even gone really live yet. But I think by the time we announce Q4 and we start talking about 2025 guidance, we'll have some pretty good visibility into the VA.

Speaker 4

Okay. Perfect. Before I switch into Fulgent Pharma, which is not a part of the business, I do wanna touch on reimbursement. Lots of news in the past few weeks. Maybe just give us a little bit more of your house view in terms of what the current environment is, getting better, getting worse, or relatively stable.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Look, there was one event, right?

Speaker 4

But yeah, one event.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Just one event, right? There was a large commercial payor, I mean, it's all public, right? It was all press release. UnitedHealthcare.

Speaker 4

Public.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

UnitedHealthcare came out and said, "We're not gonna pay for pharmacogenetic testing." And then a publicly traded company was hit pretty hard, right? And maybe others. I don't know. So it was one event, one payer, one test. I certainly don't, I don't agree with it, right? I think pharmacogenomic testing is extremely valuable, right, to patient care. And by the way, our VA contract does cover PGx as well.

Speaker 4

Yep.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

But that, you know, the VA contract doesn't rely on third-party reimbursement. So I think that was an isolated event. I don't understand the rationale, the thought process there from the payer. But again, I think that is a test that provides a lot of clinical value. And so it didn't affect Fulgent really at all. We don't have really any third-party reimbursement for pharmacogenetic testing. Most of our PGx is now through the VA, for example. And we have hospital contracts where the hospitals are working directly with us. Maybe some B2B as well. So that event didn't affect us, but you know, not a move in the right direction for the industry. And hopefully kinda fixes itself over time.

Speaker 4

Okay. But you don't see any pressure in hereditary cancer testing?

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

No.

Speaker 4

That has been the news for like maybe past few years, but.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Yeah. I mean, I guess maybe in terms of rates coming down a little bit. You know, on the hereditary cancer side, we don't see any changes in coverage. I think it's getting better, right? So, I think coverage is getting better. But, you know, I think maybe some other companies talking about rates coming down, but you know, I don't know. It happens, I guess. You know, CMS goes through cycles where they'll lower rates a little bit, and a lot of contracts, like commercial contracts, are based on the CMS rate. So if CMS comes out with a little bit lower price, it has a ripple effect, right? But it hasn't affected us too much.

Speaker 4

Okay. Great. So let's definitely switch to Fulgent Pharma, which is the other part of the business. Dr. Yin, so maybe can you share a little bit what kind of application that you guys are developing using the nano delivery nano drug delivery systems?

Ray Yin
President and Chief Scientific Officer, Fulgent Genetics

Yeah. So this is a platform originally I developed in the Army for countering biological and chemical agents, and then when I started the company, we started working on the cancer drugs, and so our first drug demonstration using the same platform is paclitaxel or FID-007. And right now, as you know, it's in phase II stage, and we're very encouraged with the preliminary data. Right now we in those nine patients, we're supposed to have about 40 patients by the end of next year to finish the phase II trial, and then we're gonna start the registration trial, but among the nine patients, those that we have six patients that had scan data. But I can't talk too much details, but we're very encouraged with the data.

The most important thing is, we also saw the continued no neuropathy side effect issues, which is often seen with Abraxane and other paclitaxel drugs. This is an extension of our phase I and phase I-B , which we didn't have that problem. We'll continue to see, which is a very good sign. This is in a very specific focused cancer patient, the head and neck squamous cell carcinoma area. The other interesting part is these head and neck cancer, the second line is wide open after Keytruda and chemo. Many of the second line trials failed because Keytruda turned out to be such a super immuno-oncology drug, which basically poked the immune system already of the patient. Any other immuno-oncology drug coming in is basically not gonna be effective.

So everybody coming back to look at the chemo possibilities, but there are no new chemo developed, particularly the chemo like ours with very good efficacy and also very much lower toxicity or safety issues. So that's becoming a very, very interesting. And we're very encouraged with this trial, which in combination with cetuximab and so the result is extremely encouraging. And so we hope to publish interim data by the June ASCO meeting so that you'll have a first sort of look at our data and to share the interesting excitement we have. And our second drug using the same delivery technology is Nano SN-38. As you know, and this is to be filed IND in late December, early January timeframe or January timeframe of 2025. And it is targeting the irinotecan resistant tumor.

As you know, irinotecan is another very broad spectrum cancer drug, which is a workhorse for treating the lower GI tract cancers. But the problem is, like for FOLFIRINOX, you know, they are first line in combination with other chemo drugs. The problem is that when patients develop the resistant tumor, there's really not a good way to solve these problems. And our preclinical data show this nano-SN-38, which SN-38 is an active component of irinotecan, except people couldn't really formulate them. For years, nobody actually made a drug. We'll be the first one if it can make it successful. And we can overcome the irinotecan resistant tumors, which is gonna be quite interesting because this is such a broad spectrum.

There are many cancers, colon cancer and ovarian cancer and everything, even prostate cancer, that all utilize irinotecan, not mentioning the other cancers. So this is such a large unmet market, which are gonna bring the second wave of our, sort of asset. And the third one is actually a broad platform. It's also extension of same polymer technology from these delivery system, but we use them as a linker for antibody-drug conjugate along with our newly invented payload family. And so we're targeting not only the established target ADC, target established target, but also the brand new targets and as a new, basically new drug therapy. So the third asset is really not a single target, drug anymore. It's actually a platform. You can plug and play.

I mean, you can turn maybe 12 target, 12 targeted ADCs, you know, together at the same time using the same linker and payload technology, and if you follow the ADC area very closely, you will know this is a heavily patented area. It's very, very competitive, and Merck paid $22 billion, licensed three ADCs from Daiichi. Just got a chance to play in the field, not mentioning the other big pharmas also spent a lot of money, BMS, you know, Amgen, all licensed technology, so we're very fortunate to have our own brand new portfolio of patents, not only one, but a portfolio of patents over the years overlapping each other, and so we're very excited with this opportunity as well. Hopefully, we'll soon are rolling out the ADC targets as well. You see it.

Speaker 4

Got it. So I know that it's still pretty early to talk about it, but thinking about long term, how do you wanna commercialize that technology? Do you think about like you doing by yourself or you're more like a partnership type of, kind of like model, like anything?

Ray Yin
President and Chief Scientific Officer, Fulgent Genetics

Yeah. That's a great question. For example, FID-007, as we see more and more, I mean, exciting results, and then there will be a better chance for partnerships. And, as Brandon explained to you earlier, we have a lot of cash. We may be able to fund like one or two of the phase III drugs, but if we partner with them, maybe we are able to fund three of the phase III, I'm sorry, more even, five or 10 of the phase III opportunities because the platform can pump in more drug candidates, right? So that, we can diversify ourselves a lot better. And this is based upon the results. This phase II is very crucial. Hopefully, we're gonna see the results sometime next year.

And then, you know, once people see the good results and there will be more interest in partnering with us, they see the power of the technology platform. And this is only one. And our SN-38, the FID-022, if we're able to successfully find the IND later this year or next year, so we'll be able to dose patients likely the second quarter. And by the end of next year, we're also gonna see some really interesting preliminary results as well. Because most patients happen to be we collected all irinotecan resistant and most of our colon cancer, which is exactly the population we're trying to target, even though we're not allowed to select the patient, but it happened to be the trial, you know, it comes with those patients and have those solutions.

Speaker 4

Got it. Oh, in the final few minutes, Paul, wanted to touch a little bit on the margin and the capital allocation strategy. As you guys mentioned, $800 million cash on the balance sheet. Do you still wanna do another M&A? How do you think about that? And then on margin, gross margin pretty good progress right now, but how do you move to the next stage?

Paul Kim
CFO, Fulgent Genetics

Yeah. So, thank you for that question. On the gross margins, we're actually very proud of what we achieved. We were in the high 20s seven quarters ago, and now we're above 40 or at 40. You know, as we focus on expansion of revenues, quality of revenues, continued streamlining, automation, the usage of our technology, our hope is that, you know, our margins will continue to grind higher. And then as far as capital allocation, I mean, all the above. We've invested in our business. You know, we've hired people, you know, bought, you know, several companies. We made a couple investments, you know, into tens of millions of dollars. We also bought back stock. So, I mean, the usage, you know, of our cash, all the options are open.

Speaker 4

Okay. Great. Any final kind of like comments, conclusion comments, like anything that you think investors have underappreciated the story, yeah, anything?

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Well, in five seconds. You know, I'm not, you know, it's hard to say, right? I think, you know, we have become a diagnostics company and a drug development company. And we're doing a good job at both of those. But that doesn't always attract the same sort of investors, right? So we think maybe there's some disconnect there. Like our diagnostics investors doesn't really, they don't really understand the, the drug development side. And maybe our drug development investors don't really understand the diagnostic side. And maybe, maybe that's on us. We need to do a better job telling the story, right? But I think that's probably the area that is kinda creating a little bit of confusion. And look, we know this hasn't been done a lot, but I think the strategies we've taken can be successful.

So, you know, we'll do a better job telling the story and continuing to show progress in the diagnostic side and continuing to show good patient outcomes on the drug development side.

Speaker 4

Great. Awesome. That wraps up our conversation. Thank you so much for joining us.

Brandon Perthuis
Chief Commercial Officer, Fulgent Genetics

Thank you.

Ray Yin
President and Chief Scientific Officer, Fulgent Genetics

Thank you.

Paul Kim
CFO, Fulgent Genetics

Thanks.

Powered by