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Ming Hsieh
Chairman & Chief Executive Officer, FULGENT GENETICS INC

[FLGT stock] Fulgent Genetics Q4 2020 Earnings Call (3/4/21)

🎥 Mar 04, 2021 📺 DueDiligence ⏱ 69m 👁 188 views
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About Ming Hsieh

Ming Hsieh, chairman and chief executive officer of Fulgent Genetics, spoke at a December 2024 event at the University of Southern California about his career and the company's growth. He said that when the COVID-19 pandemic began, Fulgent quickly shifted its capabilities to COVID-19 testing and became one of the top three companies in that market, generating more than $1.5 billion in cash from operations that he stated would be used to support cancer research. Hsieh also discussed his earlier work in biometrics, noting that a fingerprint identification system his company developed received a sole-source contract valued at about $500 million from the Department of Homeland Security. In a 2021 speech at the National Committee on U.S.-China Relations gala, Hsieh said he was a beneficiary of stable and collaborative U.S.-China relations, which he stated allowed him to change from a field farmer to a member of the National Academy of Engineering. He has also spoken about his philanthropic efforts, saying he has donated more than $100 million to support research, educational, and medical institutions. During a 2021 earnings call, Hsieh said the company expected revenue to nearly double in 2021 compared to the record revenue achieved in 2020.

Source: AI-verified profile updated from Ming Hsieh's recent appearances. Browse all interviews →

Transcript (46 segments)
O
Operator0:01
Ladies and gentlemen, thank you for standing by and welcome to the Fulgent Genetics fourth quarter 2020 earnings conference call. At this time, all participant lines are in a listen-only mode. After the speaker presentation, there will be a question-answer session. During the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I now have a conference to you speaker today, Nicole Borcha. Please go ahead.
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Nicole Borcha0:36
Great, thanks very much. Good afternoon and welcome to the Fulgent Genetics fourth quarter and full year 2020 financial results conference call. On the call today are Ming Hsieh, Chief Executive Officer; Paul Kim, Chief Financial Officer; and Brandon Perthuis, the company's 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 use 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 statement. The company has 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 future events and should listen to management's remarks today with the understanding that actual results, including the company's actual future results, may be materially different from what is described in or implied by these forward-looking statements. Please review the more detailed discussions related to these forward-looking statements, including the discussions of some of the risk factors that may cause results to differ from those described in the forward-looking statements contained in the company's filings with the Securities and Exchange Commission, including the previously filed 10-Q for the quarter ended September 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 fourth quarter of 2020 for more information, including the description of how the company calculates non-GAAP income 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.
M
Ming Hsieh3:07
Thank you, Nicole. Good afternoon and thank you for joining our call today to discuss our first quarter and the full year of 2020 results. I will provide some opening remarks before handing it over to our Chief Commercial Officer, Brandon Perthuis, to provide updates on our commercial success, and finally Paul Kim will discuss our financial results and outlook in detail. Before I start, I would like to say that our thoughts are with those who have been impacted by this pandemic and the destruction it has caused. With heavy hearts, we have continued to find a way to do our part in combating the spread of this virus, and I have been in the forefront position to provide testing and support for our customers throughout this challenging time. We look forward to leveraging our success and expertise for the greater good as we continue to battle this pandemic. With that being said, 2020 was truly a home run year for Fulgent Genetics. While the financial trajectory of our business transformed significantly over the last 12 months, our value remained consistent, and our genetic testing platform has expanded and evolved to meet the challenges that COVID-19 has presented. I want to go through the details of each step that we took to get where we are today. As I have discussed much of this in detail on prior calls, I will say that we have emerged in 2021 as a stronger, more robust business than we were a year ago, and that we are extremely well positioned to continue driving growth across our business through 2021 and beyond. Our results in the fourth quarter were truly outstanding. Our fourth quarter revenue of over $295 million is almost three times the revenue we generated in the third quarter of this year and more than 35 times our fourth quarter revenue of last year. We did more than 3 million tests in a quarter and over 4.4 million tests in a year, compared to about 60,000 tests in all of 2019. At the same time, we demonstrated incredible leverage, generating more than $6 per share in non-GAAP income in the fourth quarter and more than $9 per share in non-GAAP income in the full year, and $105.5 million in free cash flow. Paul will cover the financial details, but I want to emphasize that this leverage would not have been possible without our fundamental genetic testing technology, our proprietary lab operations and reporting system, our ability to directly secure multiple reimbursement agreements, and the execution capabilities of our sales and lab team. I'm extremely proud of what we have been able to accomplish this year, and the future of Fulgent looks very bright for years ahead. Throughout the challenging landscape and challenges in 2020, our team has not only risen to meet the demands that came our way, but has gone above and beyond to establish Fulgent as a true leader in genetic testing in the COVID-19 market. This is demonstrated in two ways: both by the customer and the contracts that we have won competitively, but perhaps more importantly by the work we have done to pioneer new approaches to lab operations and test management to make testing more accessible and efficient. I would like to highlight a few examples of this. First, on the leadership front, Fulgent was recognized as the number one provider of COVID-19 tests in the state of California by the California Department of Public Health in late January, processing the highest volume of tests with over 90% of results returned to patients within 24 hours and 97% returned within 48 hours. We have announced various wins and partnerships in the states over the last year, but to see Fulgent atop the list of all COVID-19 testing providers in California is truly a testament to our ability to execute and service customers successfully in a way that drives them to choose Fulgent over some of the largest testing providers in the country. Our approach is fundamentally different, and the proof is in the pudding when you see the success in the most populous state in our nation. Other highlights on the leadership front include multiple large testing contracts that we have continued to sign. Specific wins include a new contract with the Department of Homeland Security, as well as the extension of our testing partnership with the New York City public school system. Brandon will discuss this partnership in more detail in a few minutes. In terms of COVID-19 testing capabilities, we have kept a close eye on the new virus mutations that have emerged, and I'm pleased to announce that our tests are detecting all major mutations of the virus. We are also leveraging our next-generation sequencing capability to support COVID-19 research on the various potential mutations, which Brandon will elaborate on momentarily. In terms of new approaches to the market, we have done some exciting things with our software and technology platform, using it as a new way to service our customers. Our software offerings, including our vaccine management solutions and community testing software platform, enable our customers to better manage their testing and vaccine workflows, programs, and policies. We already have several customers who have purchased such offerings. While these programs are still very much in the early stages of rollout, we are optimistic that we will be able to leverage our software platforms as an avenue to service and maintain customers in the months and years ahead. Aside from COVID-19, our next-generation sequencing business continued to grow in 2020. Despite various lockdowns across the country, volume from NGS tests grew from 59,000 in 2019 to 72,000 in 2020. Looking ahead to 2021, we expect our NGS business will grow about 92% year over year to $70 million. And looking at our business overall, we expect revenue to almost double in 2021 compared to the record revenue achieved in 2020. With our technology platform, we expect to continue to see strong growth and strong margins due to our best-in-class cost structure. We also believe our technology platform sets a higher bar in the market by bringing business predictions, as our strategic wins have been through rigorous competitive bid processes and the sustainable value for our customers through our ability to continue to drive down the cost for the market. At the same time, by applying our technology and operational execution into adjacent areas, we will be able to join the larger market for fusion going forward. Throughout the balance of 2021, we plan to invest in sales, marketing, and initial international expansion efforts to continue driving the momentum. We also view M&A as a potential avenue to expand our addressable market into wider screening and diagnostic capabilities. On the last point, I would like to mention the philanthropic efforts that we have undertaken in recent months in response to the pandemic. Advances in engineering are an important part of the response to the challenges presented by COVID-19, but they need to be carefully applied not only to address the current circumstances but to promote a future of productive collaboration and engagement. In the fourth quarter, Fulgent donated $1 million to the National Academy of Engineering. The National Academy of Engineering, in collaboration with the China National Academy of Engineering and the United Kingdom Royal Academy of Engineering, will use the funds to identify highlights and formulate the best thinking on engineering system solutions to COVID-19. We also made an initial donation of $250,000 as part of a $1 million commitment to UIC to support cancer research initiatives. We believe supporting these projects will bring Fulgent closer to premier institutions and organizations. As we become a larger company with a wider reach than our existing addressable market, we have remained focused on building a business with long-term growth potential, and I believe we will prove that this year. The progress we have made with new customers, partnerships, service reimbursement, the scale we have created with our lab operations, the extensions of our software applications into customer use, and the ramp of our PICTURE platform together create a significant sustainable tailwind for our business. We are excited about the future and look forward to reporting on our success in the quarters ahead. With that, I would like to turn the call over to Brandon to dig into more on customer dynamics we saw this quarter. Brandon.
B
Brandon Perthuis18:48
Thanks, Ming. We'd like to again express our sympathy to those who have been impacted by this terrible virus. It has been a difficult time for many families in our country in general. The spike in cases and testing that was predicted by medical experts to happen in the fall indeed became a reality during the fourth quarter. We again saw lockdowns increase across many states, which did slow our momentum in our non-COVID-19 business. However, we have seen increasing strength in our business outside of COVID-19. Our non-COVID-19 business grew approximately 43% year over year in the fourth quarter, and we signed on over 15 contracts with new customers for services such as hereditary cancer, cardiovascular genetics, carrier screening, and neurodegenerative genetics. During the fourth quarter, we worked tirelessly to increase COVID-19 testing capacity, maintain our best-in-class turnaround time, and expand our testing footprint nationally. These efforts led to a quarter where we were able to service over 3 million patients with COVID-19 testing. At this time, we have the capacity to handle north of 100,000 tests per day across our two laboratories, with the ability to continue to scale. During the fourth quarter, we handled accelerating volume while maintaining our best-in-class RT-PCR turnaround time, delivering approximately 90% of tests within 24 hours. We believe our ability to scale our business to roughly 228 times that of what we were handling just one year ago is almost unprecedented in our industry. It is indicative of everything Fulgent represents. We are a technology platform company with the ability to excel in many areas of healthcare. We are a team of engineers, geneticists, genetic counselors, and business operators with a fierce motivation to make Fulgent a dominant force. We have proven with our platform and infrastructure that we can run a laboratory that far outpaces many genomic labs in terms of efficiency and scalability, which translates to best-in-class growth and operating margins, which Paul will elaborate on in minutes. Early in the pandemic, our COVID-19 patient volume was concentrated around drive-through testing sites and was somewhat limited to select regions in and around Southern California. Today, our COVID-19 customer base is incredibly diverse with a national reach. At this point, we have direct agreements with 11 counties for our services, many large corporations, testing organizations, sports teams, sports conferences, cruise lines, and hundreds of nursing homes and assisted living facilities, just to name a few. We announced during the fourth quarter an extension of our New York City Department of Education and Test and Trace contract. The New York City Department of Education selected Fulgent as a partner after evaluating a number of different COVID-19 testing providers through a competitive bid process. Our ability to retain this business through the 2021 school year demonstrates that our platform is not only capable of meeting the stringent needs of the school system, but our service in doing so resulted in a very positive customer experience for the New York City public school system. We believe we have built an incredible system for back-to-school testing, and we have now had months of experience and many thousands of students tested. We believe this early start in an emerging testing market will help drive additional opportunities for Fulgent. In fact, we are excited to announce we were recently selected by Clark County in the Las Vegas school district to be their back-to-school testing partner. We look forward to continuing to deploy our resources across the U.S. to help students return to school safely. One other exciting announcement, which Ming briefly mentioned, is that Fulgent was selected by the Department of Homeland Security as one of four labs chosen for a $2 billion, five-year indefinite delivery, indefinite quantity contract for COVID-19 testing. This is the largest contract we have been awarded to date. We believe with our industry-leading turnaround time, capacity, and delivery platforms, we have the ability to take on a meaningful portion of this contract and help our country's first responders stay healthy and safe. The demand for our RT-PCR COVID-19 test remains strong for both existing clients and new opportunities. We continue to build a robust sales funnel in a variety of different areas as the country continues to view testing as a critical tool to fight the virus and reopen our country. RT-PCR remains the gold standard. While rapid tests are available and being used, they cannot replace the accuracy, meaning sensitivity and specificity, of RT-PCR. Many organizations, government entities, and counties are requiring RT-PCR results. However, we do see an opportunity for rapid testing and RT-PCR results to work together. To this day, many labs are struggling with turnaround time, which limits the usefulness of RT-PCR. However, we continue to provide results in generally less than 24 hours. We believe that fast RT-PCR testing continues to be the best option for testing. We continue to monitor the situation regarding new mutations and strains of the virus. Importantly, we want to make sure our RT-PCR test can detect these new strains, which we have been able to do. Recently, there was information released by the CDC that warned that some of the new variants may be missed in testing, and there were in fact some labs who had this issue based on the RT-PCR targets used. We are pleased to report that our RT-PCR test can detect the variants published to date. While almost all of our COVID-19 testing volume has been RT-PCR based, I will remind you that we actually introduced a next-generation sequencing based test prior to launching RT-PCR. We realized quickly that the rapid turnaround time of RT-PCR is critical in controlling the spread of the virus; therefore, we did not commercialize the next-generation sequencing test as a diagnostic test. Fast forward to today, next-generation sequencing is now in the spotlight of this pandemic due to its ability to identify strains and mutations and screen for potential new mutations. We have now hit a perfect intersection of Fulgent's core competencies. We are primed and ready to take on massive NGS testing volume. With our sequencing capacity and expertise, we can handle approximately 10,000 NGS tests per day. We are currently working with local and federal government on genomic studies of this virus, which are just getting started. We believe our ability to offer both NGS and RT-PCR puts us in a leading position to partner with organizations doing these studies. Another key area of opportunity for us has been our PICTURE at-home COVID-19 test. This has proven to be an important differentiator for Fulgent and has helped many people by providing convenient access to testing. PICTURE is being used for employee testing, student testing, pre-travel testing, and athletes, just to name a few. Highlighting a couple specific use cases, we partnered with New York City and JetBlue to provide testing kits to travelers leaving New York airports during the holiday season in response to the testing travel mandates by the state. Also during the holidays, LA County launched a new COVID-19 home test collection program which allowed certain county residents to do complementary testing from home. The PICTURE platform is more than just a COVID-19 testing platform; it is a platform designed to change the way genomic testing and other testing is delivered. We believe patients will become increasingly proactive in their healthcare, and consumer-initiated testing will be a rapidly growing market. With the PICTURE platform seamlessly integrated with telemedicine, we are uniquely positioned to expand the service offering by adding many new tests in the future. We also believe we have dramatically expanded PICTURE's visibility and brand recognition due to the role the platform has played in COVID-19 testing. While COVID-19 testing has been unwavering in its demand on our business, we have continued to invest time and resources in our non-COVID-19 operations. We are excited to announce that we have launched a next-generation sequencing based pharmacogenomic test. Our pharmacogenomics test will target 44 genes and more than 140 drugs to enable personalized dosing and healthcare, and will determine if a patient is a rapid metabolizer of certain drugs or a slow metabolizer, adjusting dosing accordingly, or perhaps a different drug altogether could be recommended. While other pharmacogenomic tests are RT-PCR based and include limited targets and information, applying our expertise in next-generation sequencing allows us to unlock much more information and provide patients a more comprehensive report. We look forward to commercializing this product in 2021 and beyond. In addition to our new pharmacogenomic test, we continue to expand the number of disease-specific panels we offer and the number of conditions we test for. As published in the NCBI Genetic Testing Registry (GTR), we now offer over 19,000 genetic tests, making the Fulgent menu one of the largest in the world. We intended 2020 to be the year we dramatically expanded our commercial sales team; however, COVID-19 threw us an unexpected curveball. That said, we intend to dramatically increase our sales team headcount by the end of 2021. We believe we now have the product menu, turnaround time, and cost structure to drive significant expansion in the United States and overseas. In addition to a vastly expanded sales team, an important part of our go-to-market strategy has been increasing our managed care contracts. An incremental benefit of COVID-19 testing has been our increased exposure to payers. In the fourth quarter, we built over 1.8 million more insurance claims than we did in the fourth quarter of 2019. We have become an in-network laboratory with several regional payers and now have close working relationships with several large national payers. We believe we will continue to make meaningful progress becoming an in-network provider for our services. Another opportunity for us is the extension of our software platforms to customers, which Ming briefly touched on. We recently launched two new software products: the Fulgent Vaccine Management Platform and the Fulgent Community Testing Software as a Service product, both of which leverage the testing platforms we have built to support our massive COVID-19 testing operation. The Vaccine Management Platform is a layer added to our extremely successful technology platform, which is used by drive-through, walk-up, and other testing operations. Now on the same web-based platform, patients are able to schedule their vaccination, pick a location, arrive pre-registered with a QR code, get a digital confirmation of their first injection, and reminders for their second. This will be a fee-per-click product. The second product, the Fulgent Community Software as a Service, is a completely novel approach for us. Some counties and municipalities have their own laboratory and testing operations but lack the platform technology to scale and effectively manage testing. In this case, they can now take a license to our Fulgent Community Software as a Service product. Essentially, it's a Fulgent front end, but instead of pointing the order to our laboratory, it will point it to our customer's lab. This will be a subscription service billed annually along with a fee per click. We have a number of irons in the fire as we work to emerge on the other side of this pandemic, and we look forward to what the future holds for Fulgent. I would now like to turn the call over to Paul Kim, who will walk you through our fourth quarter and full year 2020 financial performance. Thanks.
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Paul Kim30:38
Record fourth quarter revenues totaled almost $295 million, an increase of more than 3,400% compared to the fourth quarter of 2019. Billable tests in the quarter totaled almost 3.2 million, growing more than 200 times the volume of Q4 last year. The vast majority of this volume was from our business related to COVID-19. Despite the re-emergence of a state-wide lockdown in California and stay-at-home orders elsewhere, we saw stable demand for our traditional genetic testing business in Q4. Our core business in Q4 was up 43% year-over-year and 17% sequentially from Q3. We finished the year at almost $37 million in revenues from our core business, which was slightly lower than our original projection before the pandemic hit. Overall, our Q4 results far exceeded our expectations, largely due to the unwavering demand for our COVID-19 capabilities. Our customer base continued to diversify, and in the fourth quarter we added six major customers who are contributing multi-million dollars each in quarterly revenues. Our ASP in the fourth quarter was $93, slightly lower than the $98 we saw in the third quarter. While our ASP has largely remained stable over the last few quarters, the modest decrease is due to the increasing mix of tests for COVID-19 versus non-COVID-19. Cost per test for the quarter was a record low of $16, an improvement of approximately 36% compared to the last quarter. Gross margin continued to improve and was up more than eight percentage points sequentially. The gross margin improvement we've seen is a further testament to the scalability and leverage in our platform as revenue increased almost three-fold sequentially and we drove further efficiencies in our lab operations and unit economics. Now turning to operating expenses, total GAAP operating expenses were $17.3 million in the fourth quarter, up from $11.9 million in the third quarter. Non-GAAP operating expenses totaled $14.8 million, up from $9.2 million last quarter. Our non-GAAP operating margins improved 12 percentage points sequentially to 77.6%. We continue to make meaningful investments across all our departments in the quarter, but our top line outperformance and increasing operating efficiencies continue to outpace the investments into our business. Based on our profits, we recorded a 26% tax rate in Q4. Adjusted EBITDA for the fourth quarter was $230 million, compared to $1.1 million in the fourth quarter of 2019. On a non-GAAP basis and excluding equity-based compensation expense, income for the quarter was $167.5 million, or $6.20 per share, based on 27 million weighted average diluted shares outstanding. Turning over to the balance sheet, at the end of the fourth quarter we had $432 million in cash, cash equivalents, and marketable securities. During the fourth quarter, our equity shelf program enabled us to sell approximately 4.7 million more shares, raising almost $204 million in cash, net of issuance costs. We have not executed on any shelf program since December 31, as we minimize dilution to our shareholder base. On the other side of the balance sheet, our contract liabilities sit at $26.6 million. I'll also quickly touch on the financial highlights for full year 2020. Revenues totaled $422 million, up almost 1,200% year over year. Operating income totaled $290 million versus an operating loss of $428,000 last year. Non-GAAP EPS was $9.10 based on 24.1 million weighted average diluted shares outstanding. Now moving on to our outlook, we see significant opportunity in 2021 to extend our leadership with COVID-19 testing, while our genetic testing business should continue to expand. As we look at revenue streams in 2021, we see a more diverse mix of revenue drivers contributing to COVID-19. In addition to RT-PCR testing, we see growth potential from our NGS-based COVID-19 test as we continue to win more customers who want sequencing to understand the characteristics of COVID-19.
M
Ming Hsieh35:12
As well as a growing number of variants, we also expect to generate revenue from our software licensing as customers are beginning to purchase our software to utilize their own environments for various applications. Further, we see continued growth in our at-home platform, Picture Genetics, for both COVID and non-COVID tests. On the non-COVID front, we continue to expand our content and introduce more tests into multiple areas including oncology and reproductive health. In addition to the aforementioned momentum, we see continued benefits from expanded partnerships on the reimbursement front by being able to anticipate payments for tests delivered. Based on our initial outlook for momentum in 2021, we expect test volume in 2021 to be over 8.5 million, which translates to approximately $800 million in revenue, representing a growth of 90% year-over-year. In the first quarter of 2021, we expect revenues to be approximately $325 million. Of the $800 million, we estimate approximately $70 million in revenue from NGS testing and $730 million in revenues from RT-PCR or non-NGS tests.
We define NGS revenues as revenue from our traditional genetic testing business plus revenues from our NGS-based COVID sequencing. These NGS test agreements include long-term contracts with major regulatory organizations, which provide important baseline information for COVID-19 and other infectious diseases for national and state-level surveillance, defining important changes in transmission, identifying unusual or emerging variants, and ultimately improving the public health response and decision making with better laboratory data on a going-forward basis. We believe our revenues from NGS testing will be more sustainable as it is less volatile than the evolving COVID testing market, which is driving our revenues from non-NGS testing. We also note that $70 million represents a 92% growth in our NGS business compared to 2020.
From a profitability standpoint, we expect to show ongoing leverage in our business which drops to the bottom line and drives cash flow generation. We continue to rely on our foundational technology for operating our business, which is producing gross margins above 80% and operating margins above 70%. Even with aggressive hiring and investments in our business, we anticipate growth and operating margin will remain extremely strong. As such, for the full year 2021, utilizing an estimated 27% tax rate and an estimated share count of 31 million, we expect net income of approximately $380 million, or approximately $12.50 per share for our shareholders, excluding stock-based compensation. Before we turn it over to questions, I'd like to make a few comments on our balance sheet and capital structure. As of the date of our earnings report, our cash balance has grown from $432 million at year end to $625 million from our operations in January and February. That plus our accounts receivable, which stand over $200 million, combined with guidance of $800 million in revenue and $380 million in profits, position the company to have a cash position above a billion dollars sooner rather than later. We're proud of Fulgent's capital structure as we achieve this feat organically with minimal dilution to our shareholders. By capitalizing on opportunities armed with our technology platform, we believe we're much stronger than we were a year ago with expanded capabilities that address a much larger market. As such, we continue to assess strategic M&A targets on a regular basis. We also plan on opening up new markets in Asia and Europe in the future. Thank you for joining our call today. Operator, you can now open it up for questions.
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Operator39:29
Thank you. As a reminder, to ask a question, you will need to press star one on your telephone. And to withdraw your question, just press the pound key. Please stand by while we compile the queue roster. Our first question will come from the line of Steven Ma from Piper Sandler. You may begin.
S
Steven Ma39:48
Oh, great. Thank you, and congratulations on the quarter and the full year. Well done. Thank you, Stephen. So just a couple questions on California and then also on the 2021 guide. I know from our internal channel checks, you seem to be pretty overweight in California. So should we think of that trend continuing in 2021? And how has that been trending in the first months of the year as well? And then secondly, on the cadence of the guide, your Q1 guide implies about 40% of total 2021 revenues. Just maybe a little bit of details on that. Do you expect a drop in COVID testing volumes in Q2 and just maybe a little bit more color on that? Thank you.
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Paul Kim40:43
Okay, thanks for the question, Steven. In terms of the concentration in California, because we are positioned in Los Angeles and Los Angeles County, it is true that a meaningful amount of revenues come from that county. But having said that, we have continued to diversify our business within the state to various other counties, as well as a number of other states. So if you take a look at the characteristics of our Q4 revenues at about $295 million, only about a quarter of that came from LA County. The other thing I would also say is in terms of the guidance, back in 2020 we were one of the few companies to have guidance throughout the course of the year, and we're pleased to exceed the expectations in each one of those quarters and for the year. In looking out at 2021 for a company that is largely centered around COVID testing, we believe that we have confidence in our market share as well as in our positioning to have formal guidance even this early on in the year. If you take a look at our confidence, that's based on the contracts that we have and the outlook even as deep as Q3 and Q4. That can certainly change if the testing landscape changes, but on a conservative basis we feel confident with the $800 million in revenue. So if you break out the $800 million in revenue into two components, NGS and non-NGS, we see the non-NGS portion or approximately $730 million in revenue being a 65 to 35 split. That can certainly change if our market position and the testing environment changes as we get deeper into the year, but that's what we feel comfortable with. On the flip side, on the NGS side, based on the progress we made from a number of different fronts including reimbursement and corporate customers that we have been introduced to through COVID, some of those corporate customers are very well aware of our capabilities and we have executed on contracts which bolsters our confidence in being able to hit that $70 million. In terms of the gradient of how that $70 million will play out, we see Q1 NGS revenues being flat to slightly up, but that should accelerate nicely as we get into the future quarters throughout 2021.
S
Steven Ma43:43
Okay, great. Thanks for the color. And maybe just if I can sneak in one quick one on the Department of Homeland Security's contract. Can you give us a little bit more details, such as how many other parties are within that contract, and what proportion of that $2 billion can you get? Give us a sense. Is it all the testing that you can handle or is there some other structure in terms of the volumes you might get from that? Thank you.
B
Brandon Perthuis44:09
Yeah, thanks Steven. The Department of Homeland Security contract, $2 billion over five years, it's an IDIQ contract. We're one of four laboratories that are named in that contract. So that's going to have pretty far reach from the Department of Homeland Security, multiple departments, a lot of employees. And it's essentially driven by the demand for testing. So these are task orders from the government that come in that need testing services and testing kits. I think with Fulgent's delivery platform, our reach, our turnaround time, of the labs that are a part of it, I do think we stand out a little bit. We do have the capacity to take on a meaningful portion of that. I mentioned where we are today, north of 100,000 per day capacity, and between our two labs we can continue to grow that. So it'll be entirely driven by the demand for testing. Some of these departments are still getting back to work full-time, so to speak. So I think as the country begins to reopen and we start thinking about back to work and back to a sense of normalcy, testing with the Department of Homeland Security will continue to be a growing area for Fulgent and testing in general.
S
Steven Ma45:26
Okay, great. Thank you.
O
Operator45:30
Our next question comes from the line of Kevin DeGeeter from Oppenheimer. You may begin.
S
Susan45:38
Hi, this is Susan calling in for Kevin. First question, I actually just want to tap on to the geographic split between California and other areas. Based on our model, it looks like the percentage from California increases in Q1. Is that correct?
P
Paul Kim46:05
The percentage of business that we have in California it should be pretty consistent with what we saw in the fourth quarter. If you take a look at our major customers that are providing say over $10 million of revenues within the fourth quarter, we have a number of different counties driving those revenues. Aside from LA County, San Bernardino County, we have Santa Clara County, Long Beach, Anaheim, several others. And we see the level of testing and the demand for our services being pretty consistent within those customers compared to the fourth quarter.
S
Susan46:54
Great. Just one more related to COVID. Do you guys have a sense of how large the market is for COVID variant characterization?
M
Ming Hsieh47:07
So the market definitely is there. I'll make a few comments and then I'll turn it over to Brandon. The market is there in a bigger way for the variants aside from the testing on the NGS side. And that's what has me really excited, because if you take a look at the NGS and the contracts that we have signed, these are major organizations that are in the business of policy and standards setting. It's a very, very competitive bid. These are sizable contracts, and they chose Fulgent based on our quality capabilities and the value that we have. And the value that we have is really unique. The amount of COVID volume that we do is obvious, but what is not so obvious is the capabilities of the company before COVID, because we're a genetic testing company that was at the highest end of testing capabilities for next-generation sequencing. We were at a perfect spot to capitalize on some of those opportunities and ink those contracts. We believe that these contracts will have very good legs because it is more predictable, sustainable, less volatile, and not tied directly to the demand for testing. And we see these contracts as something that will have years of growth for the company.
B
Brandon Perthuis48:56
We also are building several projects with various pharmaceutical companies related to NGS tests for COVID-19. To answer your question directly, how does the market look? The market for testing goes up and down through each one of the waves, and we're in a different environment now because of the vaccine distribution. So we fully recognize that, and that's the reason why we have confidence in the $800 million. But we are anticipating the immediate testing revenues from say drive-through sites to go down. If it doesn't go down, we can certainly change our guidance. But what we are excited about is our positioning within that testing market. We believe we're gaining market share and we can clearly see that. The other thing that we see in the testing area is that you will begin to see the concentration not only in LA County but in the state of California become more diversified. I've talked about the state of New York, but other big states like Texas and Florida, we believe the testing revenues in those states will increase. And then if you combine that with the need to do work for the variants analysis, which first centers around COVID but really is about highly infectious diseases, we believe we can offer a tremendous amount of value to governmental bodies by being invited to execute on full sequencing. And the other thing that Ming just mentioned is from the commercial basis, we are being invited more to do full sequencing for pharmaceutical organizations. So if you take a look at the testing environment, we think that it's a better characterization to report not just COVID and non-COVID. We think a better way to characterize it would be NGS versus non-NGS. And then if the software revenues, which we're very excited about, become more meaningful, we certainly look forward to updating the investment community.
S
Susan51:48
Oh, thank you for all that color. If I may, that was a very good, long answer. A couple questions on your core business. Do you guys have a priority listing in mind for the different things that you mentioned for business development in the future?
P
Paul Kim52:09
Yeah, so let me take a shot at that and then I'll turn it over to Ming about some business development. In terms of the COVID landscape, if you take a look at how we built our business, the amount that we invested in COVID from a dollar perspective was very minimal. In terms of the priorities, we believe our ability to run a business efficiently and show our capabilities can certainly have a very good positioning within the COVID marketplace. What we are more concentrated on is the NGS side, really utilizing our technologies to bring better business discipline, value, costs, and sustainable adoption into the marketplace. So that includes things like next-generation sequencing that we were fully comfortable with. We are also evaluating other kinds of modalities to address the wider market. And I'll turn it over to Ming, who will make comments on business development and investment in certain areas in the future.
M
Ming Hsieh53:35
Thank you, Paul. So I think we talked a little bit about COVID-19. Most of our fourth quarter and first quarter revenue comes through the drive-through test, but as schools reopen, people go back to work and start to travel, we will see the revenues shift from the drive-through to the return to normal situations. So that's related to the COVID side. In terms of NGS, we are ramping up our pharmacogenomic testing, which is a new product we offer. We should also go through our partner channels to offer the same disease, which is signed at the customers to use our products for patient treatment related to precision medicine. So Brandon, I think that covers it adequately. We'll move on to the next question.
O
Operator54:59
Thank you. Our next question comes from the line of Erin Wright from Credit Suisse. You may begin.
E
Erin Wright55:07
Great, thanks. So just to clarify, and sorry if you said this already, but in terms of the $70 million in NGS testing revenue, how much of that is related to COVID testing versus the underlying business?
P
Paul Kim55:22
A minor portion is related to COVID testing. Some of these contracts are new. We're very excited about it. We think those new contracts certainly have a lot of upside that we haven't incorporated into that $70 million.
E
Erin Wright55:43
Okay, so that's helpful. And then what does your guidance assume in terms of reimbursement for COVID PCR testing? How are you thinking about the sustainability of ASPs?
B
Brandon Perthuis55:57
Hey Erin, it's Brandon. Our expectations for ASPs are to stay generally flat. I think they're in a sweet spot. We haven't heard of any expected changes in that, so our model would keep ASPs pretty flat. And the collection experience, Erin, has been very, very good. We've written off hardly any receivables that we have on the balance sheet. The reimbursement experience has been fast because over half our revenues are through reimbursement right now, and the experience has been very good. So we feel very good about the rate as well as what we'll encounter in 2021. It's evolving, but it looks like NGS COVID-19 is going to fetch a bit more of a premium in terms of ASPs as well, so we'll see how that falls into the mix.
E
Erin Wright56:51
Okay, great. And when we think about some of these partnerships with like sports teams, cruise lines, are they largely exclusive relationships or have any sort of minimum volume commitments? And how are you thinking about the competitive landscape with antigen testing?
B
Brandon Perthuis57:06
Some of them are exclusive, some are semi-exclusive, some are multi-year, some have minimums, some don't. With the number of clients we have, the volume we're doing, you can imagine it's pretty dynamic in terms of what these terms look like. But there's a lot of competition out there. I do think we stand out of the crowd quite a bit. We have the complete service offering, our customers love us, we deliver, meet our turnaround time, make their lives easier with our technology platforms, and we have the capacity. We're confident in the contracts we have. We'll continue to be their preferred partner. Antigen testing pops up. Some of our largest municipalities have tried some of those kits that were given to them by the federal government. They don't use them very much. The accuracy is not there. It's faster, but I think people want to get the answer right. The feedback we receive from our customers that have run those in parallel, they continue to see RT-PCR as the gold standard, especially when you can turn it around in less than 24 hours depending upon when we get the sample. Some of our RT-PCR results are out in eight hours. So I think that's a pretty powerful tool that we have to continue to offer.
E
Erin Wright58:26
Okay, great. And then one last one—
M
Ming Hsieh58:33
Adding a few comments. I think people have ignored the importance of the back-end software tracking system. If you take a look at the operational results, we handled 4.4 million tests last year. You can hear the labs, from the largest labs to the on-commercial ones, they always had issues dealing with the customer, missing samples, inaccurate tests. But Fulgent Genetics last year tremendously stood out among the crowd. We never reported the loss of a single sample, and we never ran the test with failures. So looking forward, our platform will continue to expand and will continue to deliver in this market and also address the new market that we see emerging.
E
Erin Wright59:50
Okay, that's helpful. And in light of new markets and what you're contemplating, how should we be thinking about your revenue mix in 2022? Do you think a huge component of it will be non-NGS testing? Will it be meaningful in 2022, or does it just become all NGS testing, or is there another third that we don't even know about?
P
Paul Kim1:00:12
I think the short answer is we believe we'll have both NGS and non-NGS testing. If you take a look at how we laid out the guidance, we talked about the $70 million and what that includes and why we're excited. On the COVID testing front, there are different categories of COVID testing: drive-through sites and then there are post-vaccine contracts that we have signed on that include things like schools, travel and leisure, and opening up corporations. When you take a look at what they want to do in terms of testing as part of their policy, we believe that has business extension beyond 2021. To the extent of how much that would be, we see what we have signed on and feel comfortable with the guidance. But there's potential that that market might still continue to be healthy. What we have more confidence in, regardless of how the landscape looks, is our positioning within that market. We believe we're continuing to capture market share within the COVID testing space even today as vaccines are being administered.
M
Ming Hsieh1:02:06
Adding to Paul's comments, we do believe the COVID testing will remain for our business for a while. The University of Hong Kong research team yesterday published a paper on the Lancet that identified even though an individual is vaccinated, that person still has the capability to transmit the virus. So this brings a new challenge to society: how do we do prevention even when people are vaccinated? With the return to travel, airlines require travelers to be tested for COVID-19. People going back to work and school still need to make sure there is no infection. So we do believe the COVID test will still be there. It is very early for us to make predictions now. We did not add all those things into our guidance. The same for the DHS contract that Brandon mentioned; we did not add that one as part of our estimate. So as Paul mentioned, it is early in the year. We are armed with our technology and capabilities not only to address the COVID-19 market. Our capabilities far beyond what we could do for COVID-19. We will work aggressively on new R&D development, invest heavily in cancer and cancer-related diagnostics. So we do believe we have a sustained power in this market to continue to gain market share while protecting our shareholders' value.
E
Erin Wright1:04:56
Okay, that's helpful. Thank you.
O
Operator1:05:00
Thank you. Our last question will come from the line of Sonja Nam from BTIG. You may begin.
S
Sonja Nam1:05:07
Hi, thanks for taking the questions. Hopefully a couple of quick ones. One on COVID surveillance going forward. Just a clarification on the Department of Homeland Security contract: does that entail next-gen sequencing solely, or is that a combination of both PCR and next-gen sequencing? And are you seeing interest from local and state governments around surveillance of the COVID pandemic? But are you seeing any concerted effort at the national level in terms of building out infrastructure for not only COVID surveillance but for other pandemic surveillance down the road? Are you seeing anything internationally in terms of potential interest or demand?
B
Brandon Perthuis1:05:51
The Department of Homeland Security contract is strictly RT-PCR. They're looking to screen their employees, enable early detection, get people out of the workforce, keep the rest healthy, minimize the spread. I think it's exactly what RT-PCR is meant to do in an asymptomatic screening type setting. We are seeing national efforts around NGS. The CDC is involved, HHS is involved. We are involved at that level. The genomic testing is again in the spotlight right now. Monitoring these variants, seeing how they're responding to therapies, seeing how they're responding to the vaccine. Are the vaccines working on these variants? We've seen some homegrown variants pop up in the United States. I also think we're going to learn a lot about therapeutics in the future. I see RT-PCR also playing a role as a bit of a companion diagnostic. As we differentiate between the flu and COVID-19, those symptoms are very similar, but perhaps those treatments could be vastly different. So we do need a definitive diagnosis more so than just symptoms. I think we'll continue to see a push to do more genomic studies, and we applaud the money being set aside as part of the budget and the CDC and HHS involvement.
M
Ming Hsieh1:07:21
Great, that's helpful. So, adding to Brandon's comments, if you take a look where we were last year, we were not involved in the respiratory infection disease detections. I can say now we will be the leader in that area. Not only COVID-19, but all respiratory tract infection diseases—we will be in that market.
S
Sonja Nam1:07:57
Great, that's very helpful. And then just lastly, in terms of your international opportunities for investing in international opportunities going forward, could you talk about what that could look like? Would that largely mirror what you're doing in the U.S., or are there distinct opportunities outside the U.S. that you're considering? Thank you. Ming, do you want to take that last one?
M
Ming Hsieh1:08:17
Thank you. Yes, I think Sonja, we are looking at expansions in Europe and we are looking at expansions in Asia. So we'll update you in the coming quarters about our progress.
S
Sonja Nam1:08:38
Okay, thank you. Thank you.
O
Operator1:08:42
And I'm not showing any further questions in the queue. I'd like to turn the call back over to the speakers for any closing remarks.
P
Paul Kim1:08:50
Thanks so much. Looking forward to speaking to investors in the week ahead. Have a great day. Thank you.
O
Operator1:09:00
Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.