Earnings Labs

Fulgent Genetics, Inc. (FLGT)

Q4 2019 Earnings Call· Tue, Mar 10, 2020

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. And welcome to the Q4 2019 Fulgent Genetics Earnings Conference Call. [Operator Instructions] Please be advised, that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, Ms. Nicole Borsje, with Investor Relations. Thank you. Please go ahead.

Nicole Borsje

Analyst

Great, thanks. Good afternoon, and welcome to the Fulgent Genetics Fourth quarter and full year 2019 financial results conference call. On the call today is Ming Hsieh, Chief Executive Officer; Paul Kim, Chief Financial Officer; and Brandon Perthuis, Chief Commercial Officer. The company's press release discussing it's 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 such as predictions of 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 the forward-looking statements contained in the company's filings with the Securities and Exchange Commission, including the previously filed 10-Q for the third quarter of 2019 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 regarding -- discussing it's financial results for the third quarter 2019 for more information, including description of how the company calculates non-GAAP earnings and earnings per share and a reconciliation of these financial measures to income and incomes per share, the most directly comparable GAAP financial measures. With that, I'd now like to turn the call over to Ming.

Ming Hsieh

Analyst · Credit Suisse. Your line is now open

Thank you, Nicole. Good afternoon and thank you for joining us today to discuss our fourth quarter and the full year 2019 results. I will review the highlights from the fourth quarter details before handling to Brandon Perthuis, our newly appointed Chief Commercial Officer to provide updates on our go-to-market strategy. Finally, Paul Kim, our Chief Financial Officer, will discuss our financial results and 2020 outlook in detail. We finished the year with a good fourth quarter as revenue for the full year within our most recent guidance range. I'm very pleased that we achieved organic growth over of more than 50% for the year, and [indiscernible] more than 160% year-over-year. At the same time, we saw strong bottom-line and generated approximately $5 million in adjusted EBITDA for the year along with positive operating cash flow. So specifically, regarding the fourth quarter, revenue grew 48% year-over-year to $8.4 million. Billable test increased 118% year-over-year to 13,977. Our ASP was $600, an increase of 20% compared to the third quarter of 2019, benefit from the shift of mix of our tests of running to hire ASP tests. At the same time, our cost per test increased modestly in the quarter, primarily due to both shift in mix of tests, as well as reduced the benefit from economies of scale as our test volumes in the fourth quarter declined from the regular volume we saw in Q3. Non-GAAP gross margin in the fourth quarter was 59%, up approximately six percentage points from the fourth quarter last year, and then down approximately 5% point sequentially. GAAP loss was $296,000 and non-GAAP income was $778,000. Adjusted EBITDA was positive $1.1 million in the fourth quarter. Coming off a record third quarter for the company, we were pleased with the result we achieved in the…

Brandon Perthuis

Analyst · Credit Suisse. Your line is now open

Thanks, Ming. Before I dive into the updates on our go-to-market strategy, I'd like to take a minute to briefly introduce myself to those of you who I may not have met. I joined Fulgent in mid-2017 after spending 10 years at Baylor College of Medicine, and Baylor Genetics in Houston, Texas, and I've been overseeing the commercial activities and sales organization at Fulgent for the last two and a half years. During my time at Fulgent, I've come to understand how our technology and approach truly set us apart from other laboratories in the market. Specifically, the Fulgent Laboratory Information Management System, or FLIMS for short, serves as the engine that drives many of our efficiencies. These include proprietary pipelines and alignment tools to tackle the difficult areas of a genome, such as pseudo gene. FLIMS reduces labor time for curation and sign-out using computer learning and suppression algorithms to help our scientists get to the answer faster, with less need for confirmatory studies. Our technology platform also allows us to be the only lab that enables our physician clients to customize genetic tests in real-time. We also recently became the first lab to routinely use next-generation sequencing for parental studies, which we have shown to be critically important in detecting clinically relevant germline mosaicism; this was recently published in the Journal of Molecular Diagnostics. Finally, our technology platform serves as the engine for rapid product development in R&D, which allowed Fulgent to maintain one of the largest test menus in the industry. On the go-to-market front, we've been focused on expanding our test menu, improving reports with robust clinical content, improving turnaround times, securing in-network status with the payers, and expanding our global sales organization to capture share in markets where we see opportunity for growth. Specifically, we have made key international hires to better support existing clients and penetrate those markets. At the time of our IPO in 2016, Fulgent was a rare disease company; today, we are comprehensive lab offering testing that spans all areas of genetic health, including prenatal, preimplantation, reproductive carrier screening, cardiovascular disease, neurodegenerative disease, and both, hereditary and somatic cancer. We are excited to see the new opportunities are expanded to you as created. And finally, we've talked a lot about partnerships in the past with organizations such as the Parkinson's Foundation and Columbia University; these types of partnerships remain a key part of our growth strategy going forward and we intend to continue to build deep relationships with clients around our technology and services. These types of relationships include biopharma laboratories and contract research organizations. I am excited to take on the opportunities that come with my new role as Chief Commercial Officer, and I look forward to continuing to contributing to the future growth of our business. I'll now turn the call over to Paul to provide the details on our financial performance in the fourth quarter. He'll also introduce our financial outlook for the full year 2020. Paul?

Paul Kim

Analyst

Thanks, Brandon. Fourth quarter revenue total $8.4 million, an increase of 48% compared to the fourth quarter of 2018. Our US business remains the most significant driver of our momentum. Revenue from the US grew 79% year-over-year in the fourth quarter, representing 74% of total revenue in the quarter, down from 82% in the third quarter. Billable test in the quarter totaled 13,997, growing 118% over Q4 of last year. As Ming mentioned, we had one customer last quarter that represented a significant portion of our test volume, that we were not expecting to see again, to that extent this quarter. Our test volumes declined sequentially to a more normalized level this quarter as expected due to less concentration from this one customer. Our ASP in the fourth quarter was $600, up 20% from the third quarter. Cost per test for the quarter was $260 on a GAAP basis, and $246 excluding equity compensation of $193,000. While we continue to see increasing efficiencies across our business, we've recorded a slightly higher cost per test this quarter compared to the third quarter due to overall volume, while personal costs and other costs remain largely consistent. Our non GAAP gross margin improved six percentage points year-over-year remaining at a healthy 59%. While our gross margins will continue to fluctuate quarter-to-quarter, with ramp in test volumes, we expect to maintain strong gross margins overall in the quarters ahead. For operating expenses our disciplined cost structure and commitment to managing expenses while investing in growth, we again delivered a positive non-GAAP operating margin in the third quarter for the third quarter in a row. Our non-GAAP operating margin was over 6% in Q4, an improvement of 14 percentage points year-over-year. We will continue to see quarterly fluctuations in the near-term as we scale. Sales…

Operator

Operator

Thank you. [Operator Instructions] Our first question comes from Rachel [ph] with Piper Sandler. Your line is now open.

Unidentified Analyst

Analyst · Credit Suisse. Your line is now open

Good afternoon. Thanks for taking the questions. So first off, I have a few questions related to coronavirus and we appreciate the comments you made. And so, were you assuming a guidance related to coronavirus, if anything? Also, I know you have minimal exposure in China, but can you talk about if you have any exposure from a supply chain or manufacturing standpoint?

Paul Kim

Analyst

Okay. So I'll first take the guidance and I'll turn it over to Ming, who can talk about where we stand with the testing, as well as our capabilities and the opportunities. We have zero amount built into our guidance related to the coronavirus opportunity.

Ming Hsieh

Analyst · Credit Suisse. Your line is now open

Yes, thank you, Paul. Thank you, Rachel. So in terms of coronavirus related to the test, our GTV [ph] in China has been validating the coronavirus tests. We do see the -- our JV in China in this year, will be much, much better than the expected growth in 2020 in terms of their test volumes and their growth. So specifically, in terms of coronavirus, we knew the current test method, which is used globally has roughly about 30% to 40% detection rate. At Fulgent, our team here has been developed [ph] new test method, one method that will be more accurate than the current one. We did submit our tests based on the regular method, PCR to FDA already, and we will submit our new comprehensive method in the next few weeks. Hopefully, this one will address the concerns of the detection rate for the coronavirus. So from a scientific point-of-view, we're very proud for our capabilities to develop such test very quickly. Definitely, how to use it; we are looking for once we get the FDA approval and the guidance on how to move forward.

Unidentified Analyst

Analyst · Credit Suisse. Your line is now open

Great, thank you. And then, my next question on corona. So we've heard from other companies that coronavirus is pressuring hospital volumes, since it's impacting patients willingness to come into a hospital setting. So can you talk about if you or your customers have seen that and if it's pressured in either [ph] testing volumes, or if you expect it to pressure it in the coming months?

Ming Hsieh

Analyst · Credit Suisse. Your line is now open

I think that Rachel, the -- in terms of regular tests, we are on the same position with all the other diagnostic laboratories based on the standard tests; we're following the CDC's guidelines. In terms of our comprehensive test is mainly used by hospitals. I think in that sense is related to how to do better detection and associated with treatment; so in that sense it is not subject the concern you have.

Brandon Perthuis

Analyst · Credit Suisse. Your line is now open

Yes. Thanks, Rachel, this is Brandon. I'll just add that we continue to use telemedicine when necessary. There was some press today about further using telemedicine to address any restrictions to hospitals into clinics. You know, Fulgent does have the ability to do at-home collections of samples, if necessary via saliva or buccal samples. So, I think Ming is correct that, in general, we don't expect any sort of disruption to patients, patient flow or patient's access to our types of services.

Unidentified Analyst

Analyst · Credit Suisse. Your line is now open

Got it makes sense. Next question; so you've talked about building out your international and local sales team this year. So can you just give us an update on how that's progressing? And when do you expect to have those teams fully hired; is it mid-year? And if you're -- just any color on that would be great, along with how many people you plan on hiring. Thank you.

Brandon Perthuis

Analyst · Credit Suisse. Your line is now open

Rachel, Brandon again, and thanks for the question. We have already put key hires in place. We are approximately halfway there, and we expect to have the remaining half in place sometime early this summer.

Unidentified Analyst

Analyst · Credit Suisse. Your line is now open

Great. That's it for me. Thanks so much.

Operator

Operator

Thank you. Our next question comes from Erin Wright with Credit Suisse. Your line is now open.

Unidentified Analyst

Analyst · Credit Suisse. Your line is now open

Hi, this is Katie [ph] on for Erin. Can you talk or speak to some of the key drivers for volume in the quarter, particularly across, oncology and reproductive health? Thanks.

Ming Hsieh

Analyst · Credit Suisse. Your line is now open

Sure. As we indicated on our prior calls, we introduced many tests in 2019; we're a much more diversified company than we have been. Having said that, our traditional rare disease and the pediatric part of the market is holding into strong; but if you take a look at the composition of what we're selling, it's much beyond pediatric and rare disease. During the quarter, we had a nice mix of products in the area of oncology; we also had a nice mix of products in the area of cardio, as well as women's reproductive health. And our sequencing as a service business also chimed in very strongly. I know that I'm talking about strength here, Katie, but the results for the fourth quarter; it was below what we achieved in the third quarter. And I like to take a moment to explain that. As you remember, in the third quarter we had one particular customer that comprised of approximately 40% of our business during that quarter, that one customer was down to 13%. The reason why that happened was because this one customer had a significant amount of backlog in Q3, which we've adjusted [ph]. We still have this customer, it's a very important customer; but we believe that we're at a more normalized amount. If you actually strip that away and take a look at the remaining portion of our business during the fourth quarter, it actually grew by more than $1 million. That combined with the fact that we signed on over a dozen core customers who have started to order regularly from us, particularly in the last four weeks, gives us confidence and conviction and our guidance of $40 million for this year. We think that we're at an elevated state of volumes, as well as business and capabilities for Fulgent. And we fully anticipate that each of the quarters that we post in 2020 will be sequentially higher. We believe the other concern and questions that we've gotten about the ASP swinging around in 2019, you know, was of a question to a certain people. We think based on the breadth of what we're selling, a mix of what we're selling, as well as the customers and the contracts that we see; that the ASPs will be more normalized in 2020. And we should continue to see the progression of the cost per test going down in each of these quarters.

Unidentified Analyst

Analyst · Credit Suisse. Your line is now open

Okay, that's really helpful. And then, just separately, can you remind us of some of your recent collaboration, for instance, in New York State, Department of Health? And what those are contributing in terms of volume? Which collaborations are really moving the needle for you now? Thanks.

Brandon Perthuis

Analyst · Credit Suisse. Your line is now open

Hi Katie, thanks for the question. It's Brandon. With regards to the New York State, especially [ph] that you saw -- that was really a validation of our laboratory. So, after multiple years of simply to get approval by New York State, we were recently able to obtain that. So, we are now able to do business in New York State with very few restrictions. As you probably have been made aware, it's very sort of onerous process, a very detailed process to give me New York the approval; and Fulgent was able to obtain that license here in New York State. In terms from the other collaborations and partnerships, we continue to be in a tight partnership with the Parkinson's Foundation, which we've announced late last year. We're beginning to see an increase in the recruitment for that study; I mean we're very happy to be a part of that study. And then, the Columbia University is another strategic partner of ours, where we have actually licensed our FLIMS to them to help run their laboratory operation in New York. So, in addition, you know, we continue to see deep collaborations with biopharma around our sequencing as a service business.

Unidentified Analyst

Analyst · Credit Suisse. Your line is now open

Great, thanks so much.

Operator

Operator

Thank you. And I'm showing no further questions in the queue at this time. Ladies and gentlemen, thank you for your participation in today's conference. You may now disconnect.