Fulgent Genetics Inc (FLGT) 2018 Q1 法說會逐字稿

Good day, ladies and gentlemen, and thank you for standing by. Welcome to the First Quarter 2018 Fulgent Genetics Earnings Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded.

I would now like to introduce your host for today's presentation, Ms. Nicole Borsje of Investor Relations. Ma'am, please begin.

Great. Thank you. Good afternoon, and welcome to the Fulgent Genetics First Quarter 2018 Financial Results Conference Call. On the call today is Ming Hsieh, Chief Executive Officer; and Paul Kim, Chief Financial Officer.

The company's press release discussing its financial results is available on 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 future events and should listen to management's remarks today with the understanding that actual results -- 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 the forward-looking statements included in 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-K for the full year 2017, 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 the 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 first quarter 2018 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 loss and loss per share, the most directly comparable GAAP financial metric.

With that, I'd now like to turn the call over to Ming.

Thank you, Nicole. Good afternoon, and thank you for joining us on our call today to discuss our first quarter 2018 results.

I will spend a few minutes discussing updates on our recent initiatives before Paul discusses our financial results in detail.

Let me first provide a brief overview of our financial results for the first quarter. Revenue totaled $4.7 million compared to $5.3 million in the first quarter last year and up 9% sequentially from Q4 2017.

Billable tests in the quarter grew 5% year-over-year and 10% sequentially to our quarterly record of 4,621. Our ASP was $1,007, essentially flat compared to the fourth quarter.

Non-GAAP gross margins in the first quarter was 43.1%, down slightly from 43.8% in the previous quarter.

GAAP loss was $1.9 million and the non-GAAP loss was $1.2 million. Non-GAAP loss per share was $0.06 in the first quarter.

We are pleased with our first quarter results, and believe we are beginning to see stability in our business. We have begun to see momentum from our new initiatives, particularly our Beacon carrier screening test.

As we discussed last quarter, we are now using accrual method of recording this revenue and are using conservative estimate on collection rates for this test.

Looking at the accessions across our business overall, we saw increase of approximately 56% compared to first quarter of 2017.

We recognized that we are early in the process of reaccelerating our growth, but we are pleased with our initial traction and the start we had for the year.

I would like to focus on updates on key drivers of our business: first, we're seeing strong demand for our Beacon carrier screening test, which is helping drive our volume growth. We are establishing relationships with clinics, networks and organizations. As such, our customer base continues to expand. Further, we are planning on introducing a newborn screening test in coming months.

Second, we launched our somatic test panel. With introduction of this panel, we expanded our test menu beyond the traditional germline screening to provide the more comprehensive cancer screening option. With the launch of the somatic panel, our test menu remains one of the most comprehensive in the industry. Though we are still very early in the rollout of the somatic test, we have started to receive some samples.

Third, we've made progress on securing reimbursement agreements and signed several regional third-party contracts in the quarter.

Fourth, service revenue from the biopharma organizations is growing, and now accountable for more than 10% of our overall revenue.

Fifth, we won a strategic government contract with the Veterans Administration and look forward to serving their genetic testing needs.

Fourth -- fifth -- sixth, our China JV is operating well, and we look forward to long-term business opportunities in that market.

Lastly, expanding our lab including automation and integration, we have made a meaningful investment in our lab operations. And we now have ample capacity to handle increased volumes we expect to receive.

Overall, we are again pleased with the traction we are seeing in our business, and I believe the first quarter marks the beginning of the positive trends in 2018.

I would like now to turn the call over to Paul to provide detail on our financial performance in the first quarter. And he'll also provide update on our outlook for 2018. Paul?

Thanks, Ming. First quarter revenue totaled $4.7 million, a decrease of 12% compared to the same period a year ago, but an increase of 9% compared to the fourth quarter of 2017. We're seeing increased momentum in our business, as we gain traction with our Beacon carrier screening test and as we secure more business from our service agreements with pharma organizations.

As we discussed last quarter, we're now using the accrual method of revenue recognition for all our business, specific for carrier screening tests we are using a very conservative estimate on the collection rates of tests when recording this revenue. We will adjust the rate in the future based on actual collection experience.

Revenue from Asia has contributed -- has continued to decline and represented less than 3% of our total revenue in the first quarter compared to 29% in the first quarter 2017.

Countering this decrease was notable strength in the United States, which caused our revenue to increase sequentially and resulted in record quarterly billable tests. Billable tests were 4,621 in the first quarter, an increase of 5% to over Q1 of last year and an increase of 10% from the fourth quarter of 2017.

Our average selling price was $1,007, flat with the fourth quarter. Cost per test for the quarter was $600 on a GAAP basis and $573, excluding an equity-based compensation of $124,000.

Although average cost per test was essentially flat with what we saw in the fourth quarter 2017 we believe we are beginning to benefit from the onset of accelerating test volumes, which will lower our average cost per test going forward.

We anticipate that our average cost per test will begin to decline as we see benefits from increased volumes, better productivity and make collections on insurance claims beyond our conservative initial estimates.

Our non-GAAP gross margin was 43.1%, down slightly from 43.8% in the fourth quarter. Our gross margin will continue to fluctuate since our test mix varies and our volumes scale. Longer term, we remain confident that our differentiated technology and operating efficiencies will enhance the improving gross margins.

Now turning to operating expenses. We continue to balance investments for growth while managing expenses with the goal of reaching sustainable profitability in the future.

Sales and marketing expense on a GAAP basis was $1.1 million for the quarter, flat from last quarter. Our sales organization is now stable, and we're just beginning to see the payoff from the restructuring we made in 2017.

On research and development, we continue to invest to maintain our technology advantage and expand our test menu as evidenced by the development of our somatic test this quarter.

R&D expense in Q1 was $1.5 million, up from $1.3 million last quarter. We incurred several hundred thousands of dollars in expense related to the development of our somatic tests and enhancing our proprietary probes. This effort is largely complete. As such, incremental expense related to probes and somatic tests should be minimal in coming quarters.

Lastly, total G&A expense was $1.5 million, slightly up from $1.4 million in Q4.

Total GAAP operating expenses were $4.1 million for the quarter, up from $3.8 million last quarter. Non-GAAP operating expenses were $3.7 million.

Adjusted EBITDA loss for the quarter was $1.1 million, compared to loss of $1 million in the fourth quarter and $1.3 million in Q1 of last year.

On a non-GAAP basis and excluding equity-based compensation expense, non-GAAP loss for the quarter was $1.2 million or $0.06 loss per share based on 17.9 million common shares outstanding.

The GAAP and non-GAAP tax rate at the end of the first quarter was 22%.

Turning to the balance sheet. We remain well capitalized to support our growth. And we're comfortable with our cash position. We ended the first quarter with $38.8 million in cash, cash equivalents and marketable securities with no debt. This equates to $2.17 in cash per share.

Moving on to our outlook. As Ming discussed, we're pleased with our first quarter results and are off to a good start for the year. We are beginning to see stability in our business as our sales organization matures and as we're growing. And we see growing contributions from our new initiatives. We are still very early in the process of reaccelerating our growth, but are confident in our positioning. We made investments and changes last year in the sales area, and we're beginning to see signs that those investments are paying off. We remain on track for reaching our goals of at least $20 million of revenue for the full year. We also expect that our gross margins will continue to improve over the course of the year as our volume increases combined with experience on insurance claims. We also remain focused on controlling expenses while investing for growth.

Our profitability goals remain unchanged, though we expect some modest loss next quarter before our moving towards breakeven at the end of the year.

It is still early on our path towards accelerating growth, but we remain confident that our technology advantage as well as expanding test menu and lab capabilities can continue to drive growth in the quarters ahead and will demonstrate the viable business model we have.

Thank you, again, for joining our call today. Operator, you can now open it up for questions.

(Operator Instructions) Our first question or comment comes from the line of Erin Wright from Crédit Suisse.

Great. Can you talk or speak to the test mix in the quarter? How that influenced ASP? And kind of how we should think about that progressing, I guess, over the course of the year? And how maybe some of your newer R&D initiatives and newer test offerings influence that overall ASP metrics?

Erin, so as far as the test mix for the quarter, our core customers who purchased the complex and the larger panels, they continue to grow and they grew from what we had in the fourth quarter. We also had decent quarter for the sequencing for service with the pharma organizations. And as Ming indicated, now that accounts for over 10% of our revenues. And then, we're beginning to see a recognition of revenues from our carrier and our cardio tests, which we launched towards the late part of last year. And we're just beginning to see the revenues being recorded from those 2 particular tests, the carrier and the cardio. To give you a little bit more color into orders and revenues, our sessions are at a record, as Ming indicated, on a year-over-year basis, the sessions were up 57% or 56%. But our huge chunk of the increase in the sessions comes from the introduction of those new tests. But if you take a look at the revenues that we recorded from the carrier and the cardio tests, it totally represents 2% to 3% of our booked revenues, and that's because we used a very, very conservative rate initially on the collections based on the little experience that we had of processing insurance claims. We believe that the rate that we used, which estimates the collections is very conservative. And we believe, as that becomes more normalized, we should get an uplift in the revenues that we booked from those tests. As far as your comment on the ASPs, because a larger portion of our business now is being processed through insurance, although we booked a very small piece of revenues from that, the ASPs are being normalized with the various tests that are under our belt now, whether they be the complex panels, the exome, the carrier test, the sequencing for service, the cardio. The ASPs on average as we process more through insurance should come down. But the thing that will come down even more than the ASPs will be the COGS per test because we're processing all those tests through our lab now, and the costs are being recorded in the cost of sales. I think, in the near term, when we take a look at even as early as Q2, what all that translates into is higher billable tests. We should see top line revenues increase from what we posted in the first quarter in Q2. We'll see gross margins being raised from what we currently recorded. And on the operating expenses side, we should see that potentially be even lower than what we posted in the first quarter because in the first quarter in the operating expenses, as I indicated, we had up to $300,000 of costs that were booked for the development of the somatic tests, in addition, to the redesign of the new probes. And then as another example on the G&A side, we had the year-end audit, which is not going to be booked in its full impact on the second quarter, so you should see operating expenses be potentially lower than what we had in the first quarter.

Okay, that was great. That was a lot of information what I needed. The -- I guess, one other question just on the evolution of your sort of commercial payer relationship. So I guess, where do we stand now? And how is that sort of evolving?

Erin, we are continuing to evolve with some of those relationships. But as you may know, the insurance collection is still kind of in the early stage, because it is (inaudible) depends on the year, beginning of the year, end of the year, in-network, out-network, (inaudible). But from what we're seeing, as Paul discussed earlier, we do see -- we see the volume (inaudible) and we do start to try to make a reasonable collection. So overall, we feel that we're good in the area. We have been and always will be pioneered in terms of technology. But now we are focusing in some of the third-party relationships, includes clientship. And we do build a pretty -- or a good collection team at the present time.

I think, the other thing to note, Erin, is some companies are out there. Reimbursement is such a huge part of their strategy. For us, it's a very important part of our strategy. As Ming indicated, we are making good strides at improving the process around insurance, and we're going to see being -- more being processed through insurance, as I indicated. But from our positioning perspective, we have a core set of institutional clients, which continue to purchase from us. We have developed our sequencing for service capability. We are in the process of finalizing the development for our somatic tests. We have a sizable portion of our revenues still coming from the international side. And then, as Ming indicated on the call, on the government, we made inroads by landing a contract with the Veterans Administration. So we think that there are a lot of things under our belt. We just need to be able to capitalize on those opportunities and get the volumes, and ultimately the revenues up.

Great. And one quick last one, if I can. Do you still have a relationship with some of the larger reference laboratories like the LabCorps and Quests of the world?

Erin, we do. Actually, those reference labs start returning, we're good, and we're starting to generate the revenue, which is collectible with cash. In addition, with those relationships with the laboratories, we also have our independent contractor now working with the VA hospitals.

Our next question or comment comes from the line of Bill Quirk from Piper Jaffray.

This is Tyler Lee Etten on for Bill. Just building up the last second question. How -- in terms of reimbursement, where are we at for lives under coverage at this point?

It is very hard to try to talk about what in lives. We are talking about the 70 million in the range.

Okay. And then, I guess, you mentioned it, but then I was wondering if you could just expand on the China JV and any milestones or progress made in the quarter of any significance?

It started to -- in operation now and that we are collecting some of our royalties from that operation, but it does run slightly below our expected schedule. But in general, it is moving forward.

Got it. And then just an update on the carrier screening test. Should we assume that you'd be building out other supporting tests such as NIPT?

The NIPT, it is (inaudible) the test. We do have that capabilities. But our intention is building more -- the better value of the test such as the newborn. We will introduce the newborn test as well as a test for the personal genetic profile test, which will give you a pretty comprehensive test relative to older, the genes related to the disease and potential treatment.

(Operator Instructions) I'm showing no additional audio questions at this time. I would like to turn the conference back over to management for any closing or additional comments.

Well, thank you, again, for joining us for our call today. And operator, I think we'll be -- you can close the lines. Thank you very much. We'll record our progress and talk to you again in the next quarter.

Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone, have a wonderful day.