I'm joined here by Fulgent. We have CEO Ming Hsieh, Paul Kim, CFO, and Brandon, the chief commercial?
Chief commercial.
Yeah, good. All right. So let's just start off with, Fulgent has a pretty unique business model in the sense that even from a very low revenue base, you already had this low-cost leader position. So can you talk about this competitive advantage, maybe some of your other competitive advantages, and what you've done, to make that happen?
I think, David, thank, thank you everyone for joining us this afternoon, to have the, the presentation. I think really, what we were proud of for the Fulgent Genetics is the efficiency of our R&D, and it's also our technology platform. I think it's, if you compare to what we are doing the past 6 years when we become the public traded company, we continue to bring out the new, new tests, continue to bring the new product at a very, very efficient cost, efficient, efficiently. So I probably let the, the Brandon cover a little bit more about what is different from our competitions in the market.
Yeah, certainly. I think there's a few things. Probably the biggest thing is our comprehensive test menu.
Mm-hmm.
I think at this point, we probably have one of the largest test menus in the industry. Obviously, that menu was much smaller at the time of our IPO in 2016, but today it's 22,000 or so genetic tests, essentially spanning every area of genomic healthcare, where initially we were mostly focused on rare disease, but now that includes oncology, both somatic, hereditary, neurodegenerative genetics, you know, again, essentially every area of genomic healthcare. I think also too, in terms of our competitive advantage, a really important thing in the service industry is your turnaround time.
Like, these doctors are treating patients, they're making medical decisions, whether that's on the oncology side or the reproductive medicine side. You know, turnaround time is a big selling point in the industry, and we continue to excel there as well.
Lastly, I think, you know, we offer our clients a lot of flexibility, whereas a lot of service laboratories will have a preset list of tests that you may offer these clients. Our clients can custom design panels on the fly. They can go to our website. If they have a patient with a very unique, perhaps phenotype or maybe multiple phenotypes, that's not quite explained by one single genetic test, they can build these panels on the fly on our website, and by the time the sample hits our lab, those tests are ready to go. I think those are some of the things that make us stand out a bit.
Good. Gotcha. I want to actually, maybe, if I can, dive in a little bit more on that... on some of those cost achieving. What are some of the tangible things that you've done to reduce costs? I mean, like...
Yeah
L ab efficiencies, a bit, you know, library prep, probes...
Yeah.
You know, what are those?
I'll kick it off. I mean, Ming can probably fill in the color, but essentially, you know, we're a genetic testing laboratory that was founded by a bunch of engineers, right? And I think that's incredibly important, 'cause we've engineered every aspect of who we are. From the moment we receive the sample, we've established as many interfaces as we can with our clients so that we're almost paperless. That reduces our cost, improves our scalability.
We've automated as much as possible, and a lot of this is custom automation, whether it's through liquid handling, through robotics. Our laboratory is as automated as possible. And then a big part of the cost of running a genetic testing lab is the curation, the scientific time that is required to interpret these complex data sets.
Well, and that's really where our technology shines in terms of the AI, suppression algorithms, our proprietary databases, curation tools. We sort of shorten that window of how much time someone has to spend analyzing, you know, these samples. So there's other areas that, you know, incrementally add to that low-cost advantage. You know, our IT has been incredibly important. I sort of separate bioinformatics from IT.
I mean, IT is, you know, our ability to interface with our clients so we can speak with them in a faster, more seamless way. But, you know, it all adds up to, you know, a lab that is scalable, and that is one of the low-cost providers in the industry.
Yeah. Adding Brandon's points, at low cost, but high quality.
Right. That's a very good point. So if a lot of the cost in genetic testing, if you look at next-generation sequencing and large complex panels, could be orthogonal testing, confirmation, multiple assays to get to the answer. So think about running a panel. Well, some of our peers may run NGS, but also run a microarray or MLPA or other assays to get to the full answer.
So you mentioned earlier our engineered probes for capture sets, right? To be able to get as high a quality sequence reads off the instrument so that our informatics can deduce as much information as possible from the NGS without having to do those secondary assays.
So we're doing, you know, less work to get to the same answer, perhaps at a higher quality, especially as it relates to copy number calls and areas of the genome that are, you know, sort of difficult, right? So that's where we go above and beyond areas of high sequence homology, you know, GC-rich content, pseudogenes. We can use our proprietary tools to address those without having to go on and do secondary assays.
Very helpful. Can you talk about who your customers are? Is it the physicians? Is it the hospital systems? I mean, I'm guessing it's a degree of both. Why do they pick Fulgent? What's the message that you give to the customers on why they should pick you?
Well, all of the above, plus a lot more, right? So, yes, clients, hospitals, academic institutions, the bulk of our clients. We also have meaningful B2B relationships, and where, you know, we're sort of performing the services and other organizations may be marketing and selling and rebranding. So we have some B2B relationships.
But also another growing part of our business is our pharma services division, and that's not clinical testing. Mostly what we've talked about so far has been clinical testing, but our pharma services is more research-related transactions, where, you know, we're doing a lot of the NGS or proteomics or spatial testing for biopharma, who are outsourcing that to Fulgent.
Gotcha. What, what's on the menu? You mentioned, you know, you started with a more narrow menu. What are some of the bigger testing categories? And what—if you could, could you highlight some of the stuff? I mean, I'm sure you're going to say every test is better than others. But maybe ones that you think are definitively better than all the competitors, like specific...
Yeah.
Tests that you think are definitively better.
Well, the menu is huge, as we talked about. You know, I think an area that we've been growing a lot recently is in reproductive health or women's health, however you'd like to phrase it. Let me take a step back. So what we've done to give some additional color on our business is break it out into sort of three business units or divisions, which is our precision diagnostics, mostly what we're talking about.
We have an anatomic pathology division in our pharma services, which I just touched on there for a second. If you look within our precision diagnostics division, which is the main growth driver of the organization, I would say we're particularly strong in reproductive health.
I think our, our Beacon, our brand name, Beacon Expanded Carrier Screening test, maybe is the best in the industry, if I can use those words, in terms of its content, its ability to tackle those genes that are important for carrier screening, as well as our turnaround time.
So that's an area I think we've stood out quite a bit. In addition, we have, you know, a large menu of hereditary cancer tests, whether it's breast, ovarian, endometrial, colorectal, and we allow our clients to customize those panels. We recently launched Fulgent Oncology, so we can talk more about that, you know, on the somatic side. And then rare disease. I mean, that's our... You know, that's who we've come with public as.
You know, that's not our big growth driver these days as much as reproductive health, but, you know, the number of tests we offer in that space is incredible, right? So if a patient, if a doctor is seeing a patient with an unexplained, you know, developmental delay or other condition, diagnostic dilemma is the word we use, odds are we offer that test for them.
Got it. If you saw some positive benefit from ACOG from, say, expanded carrier screening next year, do you think that would be a benefit to reimbursement or just, or actually a benefit to volume as well as, you know, maybe there's a...
That's a really good question. Certainly, it would help with reimbursement. I mean, a lot of the payers take their lead from ACOG as well as ASRM, to some degree. ACOG is probably more the definitive body on those medical policies.
So I think we would see improvement in reimbursement, but also, the market's not fully penetrated for expanded carrier screening either. I mean, we're still working with some large opportunities and healthcare systems that are only ordering cystic fibrosis, SMA, DMD, maybe a couple other conditions on a wide, you know, scale basis, where really the market is moving towards, you know, hundreds of these conditions, because you can do it essentially in the same amount of time and the same cost. So that's where we're headed. Now, we've seen a lot of adoption of the larger panels in the infertility space.
I mean, it's pretty much standard of care now to order hundreds of genes for a patient going through an infertility treatment. But on the OB space, there's still some degree of smaller panels, and I think if ACOG were to further, you know, sort of promote or validate the larger panel approach, then you'd see more adoption from the OB-GYNs.
Got it. What are the top drivers of growth in the diagnostics area of your business over the next three to five years?
Well, I'm taking all the questions. Ming, you want to talk about the next 3-5 years?
Well, there's some therapeutic questions coming.
Okay.
Yeah.
All right. Fair enough.
If you took this one.
Okay.
He'll have a chance.
They're not tired of hearing me talk yet? You know, I think we're going to continue to see good growth in reproductive health. We've really done a good job standing out in a bit of a crowd, but also too, we're seeing consolidation in that space.
Mm-hmm.
Not near as many players as there were, you know, five years ago. So I think, you know, continuing to launch additional products in that space. You know, right now we have a handful of products, mostly led by Beacon in the reproductive space, but, you know, we do have some R&D in the space to launch more products to sell to those same customers. So I think, reproductive health is going to be a big area for us, for the foreseeable future.
Also, too, oncology. We're starting with a low denominator, so to speak, right? It's a newer initiative for us, but we've done a good job, you know, expanding those capabilities. So I think we can penetrate that space as well.
Then pharma services, you know, it's a bit lumpy for us, but if you look at our capabilities today versus like, you know, just two years ago, like we're able to address so much more of that market today. So I do think pharma services into 2024 and beyond may be a good growth driver for the organization.
All right. I'll give you a chance to speak.
I'll...
Oh, you want to add to it?
Yeah, a little bit on top of what Brandon covered. As David know, we did two acquisitions. One is Inform Diagnostics, another is CSI Laboratories. It take us a little bit longer to do the integration. You'll probably see the - we all have a tighter integration, you know, to see the benefit in 2024 and beyond. I think that that's the one area. Give us the, the time to do the integration and also to see the synergies and the efficiency out of these two acquisitions.
All right, Ming, which of the therapeutics that you acquired, Fulgent Therapeutics, are the most exciting to you? I know it's your favorite child. It's a favorite child question.
It is, David, I think we are while we continue to focus the area in the diagnostics, but we is likely using some of the acquisition we did. We called this nano delivery platform. It's really one of the platform we are very proud of it. It is a platform technology, which is validated for the Phase 1 trial in the data. When you go through the Phase 1 trial, there's hundreds of Phase 1 trials in the market. Our first drug in the market, in the Phase 1 trial, can see the very significant benefit in terms of not only the safety, our safety is better compared to our peers, but then also we see the efficacy.
Now we are planning to give our first drug, this is FID-007, into the clinical trial, for the Phase 2 studies in 2024, in the early part of 2024. Really, we're targeting the second line therapy. You see the many of the drugs, you know, target into the last line, third, fourth, and fifth line. But our first entry, we see the benefit, the window for us to get into the second line, head and neck cancer, that's one area, and then we have a few more lined up. But in addition, we're going to also get the new drug into the clinical trial. We are targeting late 2024 or early 2025, which is, we feel is very, very promising, the drug.
What really, I'm excited, all this nanotechnology helps us to have the building block to compete in the area with the patents we have, over 40 patents. One of the patents we feel very, very strong is the linker technology, which is currently the hottest market for the antibody drug conjugate, and we definitely will be playing in the market, which really puts us in the premier spot in terms of therapeutic development, so.
Gotcha. You know, post-development, or what is the strategy for commercialization of these therapeutic assets? Would you use partnerships? When would you think about the partnership? Would you go on alone? What's kind of the strategic view there?
I think, David, this is very good, the areas for us to cover. Brandon, talk about our customer base. We are working with the doctors, physicians, hospitals. Most of the very prestigious academic institutions in the oncology are our customers.
We can either go directly to market our products or to use a partner. I think that the most important thing is that we want to show the benefit of the our drug delivery is going to be efficacy and especially low side effects. And then that's the areas where we're excited, so we're definitely have a multiple way to go after the customer or the we're dealing with the current now.
Got it. You know, one thing I think nobody can deny is, you know, how successful you were with COVID. You know, just for sake of all purposes, how much revenue did you generate during COVID, if you remember? And a go-forward basis, how should we think about COVID testing? You know, do you think this is going to be done mostly at the point of care, or could you see this maybe in a large panel with flu? Do you think there's going to be a surveillance component? I mean, how do we think about...
First, on the number side...
Yeah.
Because it's a big number. I'll let Ming give the number.
Yeah. We did roughly about $2 billion COVID test in terms of revenue. But what is really, we're proud, not only the revenue, is at the time when the country need us, we provided fast and efficient service. All those tests we did, we have no errors. You know, if you compare with all the large labs in the market, they all have some type of issue in terms of quality. We come out of nowhere, not only we build the capacity quickly, but we deliver the quality...
Mm-hmm.
on time. And that only demonstrates the power of technology. I think that we are now using the same platform and technology getting into the areas Brandon mentioned about women's health. If you take a look at that area, we do not have a lot of revenue in that or presently in that space. When a company exited that space, there is strong demand in the market. We need quicker, better test, and a timely deliver the results, and Fulgent step in. That's where we see the most growth in 2023 and 2024 and beyond, so.
No, you nailed it. I mean, I'm glad most of us have forgotten because it was a crazy time. But, you know, initial COVID tests were taking, like, 2 weeks, 3 weeks. It was a total disaster. We had never did any infectious disease in the life of our company, but we saw that our technology in lab could do it. So from the day we launched until today, it was 24-hour turnaround time. And we got to the point where we were doing 100,000 tests a day in 24 hours. So like I mentioned earlier, we're a genetic testing laboratory founded by a bunch of engineers. These guys, not me, I'm on the science side.
But you know, that, that engineering approach meant everything, because we, down to the minute, down to the, like, the over-the-shoulder approach of, of engineering every single step of COVID allowed us to meet the turnaround time. In addition, we drove our COGS as low as humanly possible, right? So we were able to create a margin there, and I think we're a shining example of how to pivot, you know, given an opportunity.
And like Ming said, we were thankful to be able to help during that time. Going forward, I'm sorry. Going forward, I don't know. I mean, you know, we're not doing much at all today in terms of COVID testing. It's still out there. My mom and dad have it right now. Right? It's still out there.
The symptoms seem to be milder, and a lot of the testing seems to be a point of care with antigen testing. So PCR, we did PCR testing, by the way. PCR was great 'cause it's very accurate and very scalable, right? You know, if you try to do 100,000 antigen tests a day, you know, the ones you get for free in the mail, like, it's almost impossible. But you can scale PCR testing. So, you know, is there gonna be a time where PCR testing is big again? Only if the testing demands are through the roof, 'cause that's what you need PCR for.
Got it. Okay. You know, going back to another compliment here. You were one of the companies that the second all this cash came in and free money and, and, and low interest rate kind of environment, you didn't, you know, go full on with ridiculously high OpEx. So, you know, given the fact that there are probably dozens of companies out there, that probably did get over their skis in terms of OpEx, is there an opportunity in 2024 to, to be the acquirer, of, of some of these, lab, labs that did go over their skis in terms of costs?
Well, Steve, this is a very good question. I think the, we're very different in terms of what we do in terms of business market. I think some of the investors here knew the diagnosis space is deeply depressed due to the fact that some of those labs out there is really do not have a very sound business model. They're literally using the $2 to acquire $1 revenue. We're not in that space. Okay, definitely, we deliver the quality, we deliver the value.
As a matter of fact, if you take a look in terms of COVID test, we did about $2 million of COVID test, but we collect almost all the money. We have a very little write-off, versus our competition in this space. Every dollar they sell, they collect very little. I think definitely now it demonstrated our discipline, how do we operate this space, and give us the opportunity to be the consolidator in this market.
Got it.
Yeah, I just wanna echo his comments. I've already talked a lot, but I mean, we've done two acquisitions. All right? Those are our first two. We've done two strategic investments as well. We still have 800 and...
A lot.
$800 and a lot million. $840 or something million in cash with no, no meaningful debt. So I think one thing we've proven, without any doubt, is our platform is scalable. So could we be a consolidator in the space? Absolutely. Right? But we are taking a careful approach to our M&A, but we do look forward to deploying some of that capital going forward.
Got it. You know, I just wanna make sure I get Paul in there, 'cause I don't think he's been able to speak yet. Can you talk about the fourth quarter guide? I think it seemed like if I remember correctly, it was flat sequentially. How should we think about that in terms of the organic growth rate when we think about 2024?
I love hearing him speak. We're gonna pivot over to Brandon.
Oh, okay. Well, I mean, I think we've talked about, you know, a couple divisions, anatomic pathology and pharma services. Pharma services had a great first quarter and a great second quarter, but the business is lumpy, as we call it, right? Because it depends on the timing of the awards from biopharma and when we get the samples in and when we deliver the project. And so, you know, we're projecting a little bit down for pharma services in fourth quarter, but that's not a weakness, right?
The pipeline for pharma services looks great. I mean, the number of clients that we're gathering, the backlog, the contracts we're bidding on. So I think the long-term strength is good, but fourth quarter, just because the timing, is likely to be a little bit light on the pharma services side.
In addition, you know, we had this AP business and we see the seasonality in fourth quarter, particularly strong in fourth quarter, especially like on the derm side, for example. There's not a lot of people going to a dermatologist around Thanksgiving and Christmas to go have, you know, their face cut on during the holidays. So we do see some seasonality in that business. So, you know, we still see momentum in our precision diagnostics, but you know, we are planning for some seasonality around AP in the biopharma. But, you know, we - I think we beat every quarter this year, so...
Yeah.
We certainly reserve the right to do so.
Yeah, that's what I would mention is, you know, we started the year at $240 million of core revenue guidance, so excluding COVID.
Mm-hmm.
You know, in this tough market, we've already raised our estimates twice organically, without doing any acquisitions.
Mm-hmm.
You know, we've had multiple quarters where we've beaten the estimates, so we reserve the right to beat those estimates again in the fourth quarter.
Got it. Okay. Larry's not here, but are you guys willing to talk about Fulgent Oncology? How is that ramping up? You know, when should we see that nationally? How many regions are you in? And maybe I'll bring it back in, incorporate Paul. Is there any OpEx associated with expansion of Fulgent Oncology?
I think on an incremental basis, as we have these initiatives internally, you're gonna see efficiencies within OpEx this period. Because, you know, we have our platform, we have, you know, a lot of the fixed costs in already. So, you know, everything from development to the way we commercialize it and the expenses associated with the commercialization, you know, because we have a robust and you know big platform already, I think that you're gonna be seeing scale on the expense side.
I have a question from the lady here.
Oh, go ahead.
We don't break it out as a portion of our revenue. It would fall in precision diagnostics, in that bucket. But it is a growing business, for us. You know, it, it's great. It allows us to leverage other sales teams, other organizations, provide services that they don't offer, that we're very good at. So, it's a meaningful part of the business, and it's a growing part of the business. A little bit more in 10 seconds on oncology. We've executed really well with our R&D and our go-to-market strategy.
Our heme panel for hematological malignancies, as well as our solid tumor panel, we've put both of those through the MolDX process. They were both approved, both been priced. So those two panels are both priced over $3,000 through MolDX.
To answer your question about how many regions, I think we now have around five or so salespeople in essentially five or so regions, and these are salespeople we've hired that come from a, you know, rich history of selling, you know, oncology services. So we're in our infancy, but I think it is gonna be a high growth area for us in the future.
Thank you guys for coming. Thank you.