Ladies and gentlemen, thank you for standing by. And welcome to the Q3 2020 Fulgent Genetics Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question and answer session. [Operator Instructions] Please be advise, that today’s conference is being recorded on 9th of November, 2020. [Operator Instructions] I would now like to hand the conference over to your first speaker for today, Head of Investor Relations, Ms. Nicole Borsje. Thank you. Please go ahead, ma’am.

Great. Thanks very much. Good afternoon. And welcome to the Fulgent Genetics third quarter 2020 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 its financial results is available in the Investor Relations section of the company’s website, fulgentgenetics.com. An audio replay of this call will be available shortly after the call concludes. Please visit the Investor Relations section of the company’s website to access the audio replay. 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 it may make today to reflect actual results or changes in expectations. Listeners should not rely on any forward-looking statements as predictions of the future events and should listen to management’s remarks today with the understanding that actual events, including the company’s actual future results, may be materially different in 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 these forward-looking statements contained in the company’s filings with the Securities and Exchange Commission, including the previously filed 10-Q for the quarter ended June 30, 2020 which is 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 presented these non-GAAP financial measures because it believes they may be useful to investors for various reasons, but they 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 third quarter of 2020 for more information, including the description of how the company calculates non-GAAP earnings and earnings per share and a reconciliation of these financial measures to income and income per share, the most directly comparable GAAP financial measures. With that, I’d now like to turn the call over to Ming.

Thank you, Nicole. Thank you for joining our call today to discuss our third 2020 results. I will review the highlights from our third quarter before handing over to our Chief Commercial Officer, Brandon Perthuis to provide updates on our commercial success and a go-to-market strategy. And finally, Paul will discuss our financial results and the outlook in detail. The COVID-19 pandemic has continued to challenge both our health and our way of life this year. At Fulgent, we took early action to leverage our technology platform to build out the comprehensive positive [ph] offering to meet the increased demand for reliable testing solutions. While we have come a long way together in our effort to combat this pandemic, we still have a long road ahead for us as we look to return to normalcy. We’ll continue to do our part at Fulgent to help to get testing solutions to individuals in organizations that need them so that business, school, sporting events, travel and social engagements can resume safely. Our record growth in the third quarter is true testament to the scalability of our technology platform. We discussed last quarter, how the often seen events of this pandemic has really proven Fulgent Genetics is as a company and the result we discuss today to go one step further to demonstrate how the platform is truly unmatched in the genetic testing industry. With a modest level of investment in the infrastructure and higher comp, we’re able to grow our test volume almost 50 times or 5,000% over that in the third quarter of last year and by more than five-tenths or 500% over that in the second quarter of this year. At the same time, our gross margin improved by 19 percentage points sequentially with the operating expense only roughly doubling…

Thanks, Ming. As Ming mentioned, we delivered more than 1 million reports during the third quarter and almost 50-fold increase year-over-year and almost five-fold increase sequentially. Despite massive increase in volume that we experienced, we delivered results to our customers without any issues and with best-in-class turnaround time for RT-PCR results. During the third quarter, greater than 90% of our COVID-19 results were delivered within 24 hours. Some as fast as 8 hours to 10 hours, which our customers would agree it’s pretty incredible. This is all possible because how we built this company and how we have leveraged technology and operational excellence. We are a genetic testing laboratory built by engineers founded in technology. For years, we described ourselves as a technology company, providing clinical genetic testing and we have continually emphasized the power of our technology platform. In the third quarter, I think we have proven it and practice. Not only that, we have done it the hard way, building our business organically from the ground up. Before we get into our COVID-19 business, I would first like to highlight the strong quarter we had in our core genetic testing business. While we projected a slight decline in our core business due to the pandemic, it has rebounded much faster than we thought and grew 57% sequentially from a revenue standpoint. This has been in large part due to our ability to win new clients while maintaining relationships with existing clients, even as some of those clients experience lower test volumes amid the pandemic. To further emphasize this point, we looked at our top core business customers in the third quarter of this year and compared it to the third quarter of last year. Of those top customers -- were new. This demonstrates how our core business has…

Thanks Brandon. Third quarter revenues totaled $101.7 million, an organic increase of 883% compared to the third quarter of 2019. Billable tests in the quarter totaled 1,040,000 growing almost 5000% over Q3 of last year. The vast majority of this volume let’s from our business related to COVID-19. Though the majority of volume and revenues in the quarter were related to COVID. We saw a sharp rebound in our traditional genetic testing business, compared to Q2 to our traditional genetic testing business grew by more than 57%. The breadth of our customer base was impressive during the quarter with over a dozen companies contributing over $1 million of revenues. Our ASP in the third quarter was $98 higher than the $96 we saw in the second quarter. The increase is attributable to the vast majority of our tests now going through reimbursement and our favorable payment experience today. Cost per test for the quarter was $25 and improvement of approximately 42% compared to the second quarter. Gross margin improved almost 19% point sequentially, the primary reasons for the decrease in cost per test or continued automation efficiency. And in general, the utilization of our technology platform. Turning over to operating expenses, total GAAP operating expenses were $11.9 million for the third quarter, up from $6.9 million of the second quarter. Non-gap operating expenses totaled $9.2 million, up from [Technical Difficulty] quarter. As many mentioned, we made a small amount investment in a company [Technical Difficulty] antibody and antigen testing capabilities as well as assisting in the developing landscape for therapeutics. This translated to approximately $2.6 million charged below operating expenses. Non GAAP operating margin improved approximately 44 percentage points sequentially to 65.5%. We continue to make meaningful investments across all our departments in the quarter. But our top line out…

Thank you. [Operator Instructions] Our first question is from the line of Rachel Vatnsdal from Piper Sandler. Your line is now open.

Great. Hi. This is Rachel on for Steve. Congrats on the nice quarter you got.

Thank you.

Yes. So that was a substantial guidance increase. Can you just walk us through how we should think of the core business versus COVID revenue in that guide? And then a little more forward thinking, can you walk us through what you guys are thinking about for testing demand over the next year or two with an effective vaccine on the market following that news we saw this morning?

So I’ll take the first part of that question on the core business. And then I’ll turn it over to Ming, followed by Brandon, as to their thoughts on the landscape and the developments on the vaccine news from today. So on the core business, we were extremely pleased with how the core business performed during the quarter. As I indicated, the core business grew 57% sequentially, which translates into approximately 20,000 tests and revenues of approximately $10 million to $11 million, which is a record for the company. It’s that consistent levels with what we posted in the third quarter of 2019, which was a high point before this quarter. And looking out into Q4, we anticipate that our volume for the core business to be approximately 25,000, where the revenues being in the low teens, and the core business is performing better than we had hoped. And that’s because we’ve signed on many new customers. We also added content to our genetic testing menu across the board, whether it be cancer, women’s reproductive health, or pediatrics. And as you remember, we ended last year with approximately $32 million of revenues, all non-COVID. And before COVID had, we guided the street to $40 million of business for the year. And then during the earlier on part of this year, in March, April and May, during the first lockdown that impacted the core or the genetic testing business across the industry. But because of the additional capabilities that we made in terms of reimbursement, and the great traction that we’ve seen in reimbursement, because we’ve signed on so many more core customers, and we’ve proven ourselves for the capabilities and the efficiencies that we’ve had in the lab. We’ve seen a tremendous uptick in our core business and the back half of this year. So we’re still on track to meet the $40 million. But that $40 million of business that we had in the core business hasn’t been linear. We had a law in the springtime of the year, but we came back roaring in the back half the year. So what that tells us is if we continue on with the momentum and our capabilities as a company, our outlook for core business in 2021 should be very, very favorable. And I’ll turn it over to Ming, who can give commentaries on the vaccine.

I think this in terms of vaccine development, we welcome the news of the well vaccine development, because we do see continues the demands for the Fulgent Genetics to provide faster, quicker, and cheaper tests in terms of diagnose the COVID-19 test. The addition, as the vaccine developments have come in, adding additional requirement for the test faster and cheaper and quicker and more accurate test for the antibody test neutralizes the antigen test. So I think this has created the new opportunity for Fulgent Genetics in this space, I do not believe the COVID-19 will go away easily. But as long as there is a requirement in this space, Fulgent Genetics will be there to provide faster, quicker, and more accurate test to responses of pandemics. And Brendon can give you some of that in details.

Yes, certainly. Hi, Rachel. Brandon, we continue to believe that the COVID-19 testing is quite durable, right? We think it’s going to stretch well into 2021. At the same levels. Who knows we don’t have that crystal ball. No one does, right? But we think we’re extremely well positioned to be a major player in this market. So we think it’s going to be around with us for a while, at these levels that we are forecasting in Q4 and Q1, what we’ll see, right, but should testing even begin to slow down a little bit, the way we’ve positioned this company with our technology platforms, we’re going to continue to take market share from other people, right. A lot of our wins have been organic. That’s a fact. At the same time, we are taking market share from other people. So we think we can play a dominant role in the testing, we think is quite durable. And I think the platforms we built the turnaround time, the systems, I think we’re going to be a player for deep into 2021.

Great, thank you for all that color. And next you just give us more details and from the contractor you guys have one. For example, what are the terms and how long are they and do you have any exclusivity agreements?

All of the above Rachel. So some are exclusive, some are not. We look at the contracts they range from month a month to 24 months. I think our longest one we signed so far has been 24 months. These contracts have been government agencies, municipalities, big companies, you name it colleges, sports [Technical Difficulties] Rachel. So a lot of these contracts or laboratory services agreements like I said, some, some exclusivity, some don’t. And most of them, I would say a majority of them, do have some legs to them to where they’re going to stretch many months in deep into 2021.

Great. And then last question for me is that you guys have quite a bit attached following the COVID-19 tailwind. Can you talk about your plans for using the money to invest in the business? Thanks.

So that’s a excellent question. Yes, we generate a lot of cash based on the momentum that we had in the business, and we believe in capping off this year, it would demonstrate several things. One, the viability and the permanence of our business model to the efficiency, as well as the scalability of Fulgent Genetics and we believe [Technical Difficulty] in the our traditional genetic testing space, or in the wider screening market, that we will be one of the consolidators to take a look at businesses and technologies that we can incorporate or potentially incorporate, as our own to enhance our technological lead in addition to making a stronger company.

Yes. To add the Paul points, we’ll continue to invest the carefully to enhance our position in terms of our technology, and also our market positions.

Great. That’s it for me. Thanks, you guys.

All right. Thank you, Rachel.

Our next question is from the line of Erin Wright from Credit Suisse. Your line is now open.

Great. Thanks. You’ve always obviously been very nimble here with the COVID response, which has been impressive, but I guess how can you repurpose some of the capacity expansion in a - like a post-vaccine kind of post-COVID sort of world? How does that fit in into your longer term plan from a capacity standpoint? Thanks.

Erin, this is very good questions. As I mentioned, COVID-19 is not going to be goes away completely. Our investment in terms of capacity, it is always the multiple use, we’re not only to use our test for the COVID-19. But we also put our other genetic tests. As we continue seeing the increase for the demands, we increase our automation, this automated machines can use for multiple different purpose. As you re recall, all our lab management system and software has developed in-house. So we definitely could program or repurpose some of those equipment getting into the mixer, our complete automation for the level of automation so.

Erin, from a numbers perspective, this is Paul, so you can break out the investments that we made, as well as spending in a couple different buckets. So number one, our total fixed assets, and the equipment purchases for the year is going to be between $10 million and $15 million. And then, we have added a number of people to the organization, but not all of them are employees, many of them are consultants in the operational lab area. So if you take a look at the amount that we’re spending for COVID, versus what COVID has brought us just for this year, we’re going to be generating approximately $200 million of COVID business on top of massive profits. We’ve already gotten massive returns on those investments. So COVID is not going to go away at the end of 2020. We see these contracts going deep into 2021. We believe we’ll have material level of COVID business. So whatever investments that we’re making, we believe that we’ll have immediate returns on that. And then from an operational sense, we can quickly deviate the resources into other areas that we believe will be fruitful for the company.

Okay. That’s helpful. And then on the reimbursement front, obviously, we had favorable reimbursement for COVID testing. And CMS has extended that through late January. How long do you think that lasts there on, and do you feel comfortable I assume you feel comfortable now based on sort of your prepared remarks in terms of your turnaround time to meet their today’s requirements?

Yes. Rachel, sorry, Erin, we were happy to see what they did actually, to reward those laboratories that can actually deliver on turnaround time. We think that’s incredibly important. When it comes to contact tracing. The turnaround time needs to be 24 hours or less for this test to be as powerful as possible. [Technical Difficulty] Other their decision to do that, we hope that reimbursement rate will continue it deep into 2021. We’ll see how it plays out. I think as Paul mentioned, we do have some additional leverage in our in our cog there. So we were all also on the private side as well, not just the Medicare, Medicaid from the CMS perspective. The private side also is a satisfactory reimbursement. So we hope that will stick around, we think it will. And yes, in terms of meeting the turnaround time to get that extra reimbursement, we are incredibly confident in our abilities to do that.

Remember, the COVID-19 test started as a $50. Most of lab could not survive without price to CMS or increase the rate. And most of the labs could not meet the response time, the CMS gave the two rates $100 for the 24 hour result for the [inaudible] respond time, or the $75 if we cannot meet the 48 hours response time Fulgent Genetics another position while position to meet the time challenges, but also want to be able to perform in this market at any price to compete in this market. I think the Fulgent Genetics when we get in, we’re not the highest the provider that we provide the low cost competitive bid in the old our efforts, not only windows fitted, the effectively. But also we are able to deliver the bottom line at the results we deliver today. We will continue to enhance our position in this area, because of our technology, because of our biochemistry, and because of our pipelines.

And just to give you a point of reference on the reimbursement, we have $90 million of accounts receivable at 930. As of today, we collected on more than $60 million of that $90 million balance. And the reason why we’ve been able to get that kind of collection is because of the efficiency as well as the enhanced capabilities that we have as a company in the area of reimbursement. And as Ming indicated, the CMS reimbursement rate is $100. And on starting January 01, it stays at $100 as long as you’re able to meet the turnaround time, but because our turnaround time is just getting quicker what the additional volume, we don’t have a whole lot of doubt whether we can meet that threshold starting on January 01, 2021.

Okay. Sorry. Thank you.

Next, we have Kevin DeGeeter from Oppenheimer. Your line is now open.

Great. Thanks, guys. I want to revisit genetic testing. And Paul, some of your comments with regard to how to think about that portion of business for the year, I believe I heard you correctly, you feel comfortable kind of - at that $40 million, recorded revenue for genetic testing for the year if our math is right, that suggests somewhere around $15 million for 4Q or another 40% sequential growth in that business on top of the 57% in the current quarter. So can you just comment a little bit more about what’s driving that - what portion of the business is hereditary cancer? Is it to carrier and how should we think about if our math is right that $15 million as a, good baseline to think about building growth into 2021?

That’s an excellent point. So we are on track. What’s our original goal guidance, which is quite a feat. Because a lot of the diagnostics companies 2020 was essentially a throwaway year. But oddly enough, it seems like we’re on track to meet the original guidance in before COVID has head. And the reason why it’s accelerated in the back half the year is because during the lock down period, and even with the momentum of the COVID business, we continue to sign on additional customers and it’s across the board in cancer and women’s reproductive health, as well as in pediatrics. And we believe that things open up more and should people get more comfortable going to clinics, having the genetic -- the comfortness of returning to some kind of normalcy for the genetic tests, that’ll just open up the doors for even more enhanced business for our core NGS testing. And I’ll turn it over to Brandon, who can give more commentaries, both in terms of the number of customers, the quality of the customers, as well as the size of programs that they’re thinking about for our core business.

Kevin, yes, I think, in the script to read [Technical Difficulty] customers in Q3 this year versus last year, and actually got a text that I cut out a little bit. So I’ll re emphasize what I said, in the third quarter of this year, greater than half of those customers were new, right? We look at our largest customers in Q3, more than half of those were new this year. So Paul’s right, we’ve continued to bring on new customers, we continue to win business, these customers not running at full speed, let’s make no mistake have been impacted by this pandemic. We’re still not back open like we need to be we want to be. But this growth has been fueled by continuing to win new customers. So we think when our expanded portfolio of customers is running at full speed, when they’re seeing the same number of patients, they saw pre-pandemic can be a pretty powerful turning point for our company.

Kevin, the last thing is on the cost side, when we talked about the efficiencies that we have for COVID. But our core business, that’s also gaining a lot of benefit from the automation and the efficiency, meaning that our cost per test during Q3 on a full gap basis was 25 bucks. On a non-GAAP basis, it’s even lower than that. But that includes our core genetic tests on top of COVID. So you can just estimate what our cost structure is, whether it be for COVID, or non-COVID. We’re not going away anywhere, and we believe we can compete in any kind of environment.

Okay. Great. No. That’s super helpful. And as we think about your continued menu expansion, you did call out some opportunities with regard to infectious disease side of the portfolio, but are there important or meaningful menu expansion opportunities in genetic testing? Do you think continue to feel this type of growth to existing customers as they expand? The breadth of their ordering into a broader menu for genetic testing?

Well, Kevin, if we throw away $100 million dollars, you can easily buy a $20 million or $30 million business. Okay, but that’s another way we do. Okay. Definitely, we see the business opportunities. As we walk into the each opportunities, we need to make sure we have a sound business model, we need to make sure it is beneficial to our clients. But in addition, we need to make sure that we also provide returns to our shareholders. So with this organic growth, I think we are going to focus in the area of cancer in advance of cancer treatment. How do we do provide a precision medicine Fulgent continue to invest in these areas, we will introduce the products in this area due to the COVID-19. I think you slow down a little bit our interest introduction in this kind of our products. But it definitely does the areas that we will be focused on.

Yes. I think we’ve been on a test launch craze for the last year, a year and a half. I mean, and now the test menu is over 19,000 tests. So we continue to pump out a new test. We think that’s important, looking at different disease, different phenotypes. So yes, we continue to develop new tests. I guess, sort of tactically speaking. A couple weeks ago, we did launch a pharmacogenomics test, which we’re pretty excited about. We have not played a major role in pharmacogenetics in the past. But with our technology, our capture set, our pipelines, we were able to develop that pretty quickly. So we will be at the market, which will help in personalized therapy and drug treatment.

So very exciting. Thank you for taking my questions.

Thanks, Kevin.

[Operator Instructions] And there are no further questions as of this time. I will now turn the call back to Nicole, for any final comments.

Great. Thanks everyone for joining our call today. We look forward to keeping in touch with you in the days and weeks ahead. Have a great day.

Ladies and gentlemen, this concludes today’s conference call. Thank you all for participating. Enjoy the rest of your day. Keep safe and you may now disconnect.