NeoGenomics, Inc. (NEO)
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Earnings Call: Q3 2018

Oct 30, 2018

Operator

Greetings and welcome to the NeoGenomics third quarter 2018 financial results conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Doug VanOort, Chairman and CEO. Thank you. You may begin.

Douglas VanOort
Chairman and CEO, NeoGenomics

Thank you, Michelle. Good morning, everyone. I'd like to welcome everyone to NeoGenomics' third quarter 2018 conference call. Joining me from our Fort Myers headquarters is Sharon Virag, our chief financial officer, Rob Shovlin, president of our Clinical Services division, George Cardoza, president of our Pharma Services division, and William Bonello, chief strategy and corporate development officer and director of investor relations. Before we begin our prepared remarks, William Bonello will read the standard language about forward-looking statements.

William Bonello
Chief Strategy and Corporate Development Officer and Director of Investor Relations, NeoGenomics

This conference call may contain forward-looking statements, which represent our current expectations and beliefs about our operations, performance, financial condition, and growth opportunities. Any statements made on this call that are not statements of historical fact are forward-looking statements. These statements, by their nature, involve substantial risks and uncertainties, certain of which are beyond our control. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual outcomes and results could differ materially from those indicated in the forward-looking statements. Any forward-looking statement speaks only as of today, we undertake no obligation to update any such statements to reflect events or circumstances after today.

Before turning it back to Doug, I want to let everyone know that we will be making a copy of our transcript for this morning's call available on the investor relations section of our website shortly after the call is completed. We also want to let everyone know that we are going to limit the number of questions to two per person in order to give more people a chance to ask questions within the one hour that has been allocated for this call. Doug?

Douglas VanOort
Chairman and CEO, NeoGenomics

Thank you, Bill. For today's call, I will briefly review some key quarter three highlights and then turn the call over to Sharon for a more detailed review of the financial results. After that financial review, I will provide some additional commentary on our growth initiatives and some of the investments that we're making to drive both near-term and long-term growth. Let's begin with the quarter three highlights. Our quarter three results were very good. We reported record revenue and adjusted EBITDA with 17% top-line growth, 53% adjusted EBITDA growth, and a 39% adjusted EBITDA contribution on revenue growth. In the Clinical Services division, we drove 14% volume growth, a 3% increase in average revenue per test, and a 6% decrease in average cost per test. Those results reflected a continued gain in market share, generating double-digit volume growth across all test modalities.

Our Pharma Services division revenues grew 21% compared with last year, and we signed $21 million of new contracts for future work. At the end of quarter three, our Pharma Services division backlog was up 75% year-over-year and currently stands at $97 million. Profitability also improved as we gained leverage and continued to drive down cost per test. Our adjusted EBITDA margin of 16.3% was an all-time high, even as we continued to make significant investments for future growth. Importantly, service levels continued to be excellent, and customer retention levels remained outstanding. Our strategic and corporate development initiatives. During the quarter, we completed a $135 million equity offering, and just last week, we announced that we signed a definitive agreement to acquire Genoptix, a leading provider of oncology-focused laboratory testing, for $125 million in cash and 1 million shares of common stock.

We're excited by the Genoptix acquisition opportunities. This combination sets NeoGenomics apart from the rest of the industry with unprecedented reach to all customer segments, including hospitals, pathologists, and community oncology practices. Importantly, the acquisition expands our reach into community oncology practices, which has been a strategic priority given changes in ordering paradigms by oncologists. We believe the combination will make NeoGenomics more competitive by leveraging the best offerings from each company and will create an innovative value proposition for oncologists, pathologists, hospitals, payers, and patients. At this point, I'd like to turn the call over to our Chief Financial Officer, Sharon Virag, for a more detailed review of third quarter financial results.

Sharon Virag
CFO, NeoGenomics

Thanks, Doug. Before I begin, I'd like to remind everyone that we adopted ASC 606, effective January 1st, 2018. As part of that adoption, we restated 2017 results so that the year-over-year comparisons that we discussed include the adoption of ASC 606 for both periods. Our third quarter revenues were up $69.1 million. Actually, they weren't up $69.1 million. They were $69.1 million, a 17% increase from last year. Clinical genetic testing revenues increased 17% to $59.5 million, and Pharma Services revenue increased 21% to $9.6 million, which is an all-time high for quarterly Pharma Services revenue. Clinical genetic testing revenue, excuse me, clinical genetic testing volume increased 14% year-over-year. Importantly, this growth was balanced across all modalities with double-digit growth in every test category. Average revenue per genetic test was $320, which was up modestly, both year-over-year and sequentially.

As we discussed last quarter, we are optimistic that we are beginning to see less downward pressure on price per test than we have experienced over the past several years. Gross profit increased by $7.4 million to $32.3 million, up 30% from the prior year. This increase represents a 75% contribution on the $9.9 million of revenue growth. Gross margin improved by 468 basis points year-over-year to 46.8%. This improvement was driven by productivity gains, cost efficiencies, and the negative impact of Hurricane Harvey and Hurricane Irma on 2017 results. As Doug mentioned, average cost of goods sold per clinical genetic test, our standard cost per test metric, decreased by 6%. G&A expenses increased by $2.8 million or 15% year-over-year to $21 million. Approximately $700,000 of this increase is related to one-time non-recurring costs associated with the relocation of our Houston facility.

These moving expenses are counted as non-GAAP adjustments in our calculation of adjusted EBITDA, adjusted net income, and adjusted EPS. The balance of the increase is primarily attributable to an increased number of employees to handle our increasing growth, as well as increases in professional fees. Sales and marketing costs increased by 8% year-over-year to $6.9 million, primarily due to commissions expense on increased revenue and additional investment in marketing-related activities. Third quarter GAAP net income attributable to common shareholders was $2 million, compared to a net loss of $6.9 million in the third quarter of 2017, and diluted income per share was $0.02 versus a loss of $0.09 in the prior year.

We believe that in order to compare the net income related to the true operations of the company on a more consistent basis across periods, it is appropriate to adjust GAAP net income or loss available to common shareholders to exclude certain non-cash items and, if applicable, one-time costs. We refer to this measure as adjusted net income and on a per share basis, adjusted diluted earnings per share, and we have included a table with how these are calculated in our earnings release. Adjusted EBITDA was $11.3 million, an increase of 53% year-over-year. As Doug mentioned, the marginal adjusted EBITDA contribution on revenue growth was 39%, which is above our long-term guidance of 25%-35%.

As we have mentioned in the past, the 25%-35% guidance is a range that we expect to fall into on average, with some quarters above and some quarters below that range. In the third quarter, adjusted net income was $4.6 million, compared to a loss of approximately $600,000 in the prior year. Adjusted diluted EPS was $0.05 versus a loss of $0.01 in quarter three 2017. Cash collections were strong in the quarter. Although DSOs this quarter increased two days sequentially to 84 days, this still represents a 14-day decrease compared with last year. Cash flow from operations of $29.3 million was up significantly in the first nine months of the year compared with $12.3 million in the comparable period last year. We ended the quarter with $118 million in cash and $110 million of total debt, including capital leases.

As Doug mentioned, during the quarter, we completed a $135 million equity financing. We finished the third quarter with 1,078 full-time equivalent employees, contract doctors, and temps versus 1,063 as of June 30, 2018, and 942 as of September 30, 2017. We are updating and narrowing our full year revenue and earnings guidance. We now expect consolidated revenue to be in the range of $270 million-$272 million, which compares to prior guidance of $260 million-$272 million. We expect adjusted EBITDA to be in the range of $40 million-$42 million, which compares to prior guidance of $39 million-$43 million. Net income available to common stockholders is now expected to be $4 million-$5 million, compared to prior guidance of $1.2 million-$5.2 million. This new range includes the impact of $2.6 million of one-time transaction costs related to the proposed Genoptix acquisition.

GAAP diluted EPS is expected to be $0.04-$0.05 per share versus prior guidance of $0.01-$0.06 per share. Adjusted diluted EPS is expected to be $0.17-$0.19 per share versus prior guidance of $0.12-$0.17 per share. I will now turn the call back over to Doug to provide some additional commentary on our 2018 growth initiatives.

Douglas VanOort
Chairman and CEO, NeoGenomics

Thank you, Sharon. Before we begin the question and answer segment of the call, I'd like to highlight some important drivers of near-term and long-term growth and profitability. First, our acquisition of Genoptix will significantly accelerate our revenue and growth trajectory. Genoptix will add approximately $85 million of revenue, resulting in a pro forma combined company revenue run rate of approximately $350 million. The acquisition will also improve our level of profitability over time, as we have identified $25 million of cost synergies, which we expect to realize by the end of 2021. Second, our strong Pharma Services backlog is an important driver of revenue growth. We have $97 million of signed contracts in our backlog, and we expect approximately 70% of this backlog to convert to revenue over the next three years, including approximately 50% over the next 18 months.

Our Pharma sales team continues to perform at a very high level, and we are beginning to add to our sales capabilities outside the United States. Third, we expect that our new partnership with PPD will help drive growth, and we are extremely pleased to have established this global strategic alliance. PPD is one of the largest contract research organizations in the world, with a significant expertise in oncology trials and an outstanding reputation. Our shared objective is to provide a seamless and fully integrated global pathology and molecular testing solution to PPD's pharmaceutical and biotech clients. We have a handful of early wins and a number of bids outstanding with pharma and biotech customers today. Perhaps more importantly, the PPD and NeoGenomics commercial organizations recently met for a two-day sales strategy meeting, and our business development teams are working collaboratively to pursue new opportunities.

We're hoping to generate run-rate revenue of at least $10 million from this alliance by the end of 2019, and believe that the longer-term potential is greater than that. Fourth, we continue to add new managed care and group purchasing contracts as a result of our scale and strong ability to serve providers and payers on a national basis. On the second quarter conference call, we discussed our agreement to be a national participating in-network provider with Cigna, which was effective August 1st. In September, we announced that we had been awarded a group purchasing agreement with Premier, effective October 1st. Premier is one of the largest group purchasing organizations in the U.S., representing approximately 4,000 U.S. hospitals. This agreement opens the door for us to negotiate contracts with these member hospitals.

In addition to Cigna and Premier, we added several other important new contracts during the quarter, which will also expand our access to both hospital customers and patients. Fifth, we continue to make progress with our FDA initiative. As we discussed on previous calls, we're in the process of seeking FDA approval for a large multi-gene next-generation sequencing panel. Earlier this year, we filed our pre-submission documents, and we had a very helpful pre-submission meeting with the agency in August. We believe that an FDA-approved next-generation sequencing test offering will benefit both our Pharma Services and clinical testing divisions by further differentiating us from other oncology labs, driving reimbursement for our multi-panel test, and increasing our attractiveness to pharma companies for clinical trials involving companion diagnostics. We're also working with a major pharma sponsor on getting FDA approval for a companion diagnostic in conjunction with their drug application.

NeoGenomics is uniquely positioned to be able to work with pharma sponsors in their drug development process and take the test through the FDA all the way to commercialization with our clinical team. Finally, we're beginning to make progress with our proactive measures to address revenue per test. We have enhanced our analysis of existing reimbursement trends, identified areas where we are being significantly underpaid, and implemented a plan for improvement. These activities include securing coverage for non-covered tests, improving our billing process to avoid denials, and working those denials more effectively when they do occur. We're also evaluating our fee schedules to identify tests that are not appropriately priced. Our quarter three results suggest that we are seeing some initial benefits from these efforts. In summary, we're excited about the strength of our business, our position in the market, and our near-term and long-term growth opportunities.

Sophisticated laboratory testing plays an increasingly critical role in identifying appropriate care protocols for cancer patients, ultimately improving quality of care and saving lives. We're pleased to play an important role in this vital segment of our healthcare system and believe that our services are creating value for patients, employees, customers, and for our investors. I'll now turn the call over to Bill Bonello to lead us through question and answer period.

William Bonello
Chief Strategy and Corporate Development Officer and Director of Investor Relations, NeoGenomics

Thanks, Doug. At this point, we'd like to open the call up for questions. Incidentally, if you're listening to this conference call via webcast only and would like to submit a question, please feel free to email us at bill.bonello@neogenomics.com during the Q&A session, and we will address your questions at the end if the subject matter hasn't already been addressed by our call-in listeners. As mentioned at the beginning of this call, we would like to ask each person to limit their questions to two so that we may hear from everyone and still keep within the hour allocated for this call. Operator, you may now open up the call for questions.

Operator

Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, while we poll for questions. Our first question comes from the line of Kevin Ellich with Craig-Hallum. Please proceed with your question.

Kevin Ellich
Analyst, Craig-Hallum

Good morning. Thanks for taking the question, guys, and congrats on the good quarter. Doug, just wanted to go back to your comments on improving revenue per test and kind of what you guys are doing to identify where you're being underpaid. 3% growth on average revenue per test was great. First time we've seen that in a long while. I guess, what else are you guys uncovering and where do you think pricing can ultimately go over the next 12 to 24 months?

Sharon Virag
CFO, NeoGenomics

Thanks. This is Sharon. I'll take that one. I think we have been doing a great deal of work on our reimbursement and improving that revenue per test. I'd love to say it's sophisticated stuff. I think on the analytics side, we are getting a lot better. We've moved the organization from looking at everything on a claim-by-claim basis and really trying to get to data-driven answers on where are we seeing reimbursement not where we think it should be, and then going after those with a project plan. For example, if we see Medicaid not paying in one state for tests that it pays in another, why is that? People go down to the root cause, and then we put together an action plan for what are we going to do about Medicaid in that state. That's one of, unfortunately, a 1,000 examples.

There's a ton of work to be done because we keep uncovering these little nuggets. We're really encouraged, too. We're just at the beginning, to be honest. Where do we think it could go? We could definitely see an improvement. There will always be headwinds in reimbursement in healthcare. That's just a fact of life. I think where we have always been able to use the cost per test to offset that, we're really excited to see that we might be able to just offset it with these efforts. We think there's a long way to go. I don't know that we're ready to quantify anything, but we're just at the beginning.

Kevin Ellich
Analyst, Craig-Hallum

Great. No, that's helpful color, Sharon. Thanks so much. Just going back to the Genoptix acquisition. Nice that you guys laid out the cost synergy opportunities. Doug, I was wondering if you could talk maybe about any potential revenue synergies such as cross-selling. Also, I guess, holistically looking at your growth strategy and the investments that you guys continue to make, wondering, I guess, where you'd like to drive business over the next three to five years, and what investments are needed for that.

Douglas VanOort
Chairman and CEO, NeoGenomics

Yeah. Thanks, Kevin, and thanks for your comments about the quarter as well. We believe that there are revenue synergies for sure as a result of the Genoptix acquisition. We have not quantified those, and we have not baked those into any commitments in terms of our growth. I think the revenue synergies would include, for example, our FDA-approved tests. We've got a broader channel with oncologists as a result of this acquisition, and certainly that provides an opportunity to use this new FDA-approved assay for that channel. There are a lot of other opportunities that we believe we have on the revenue synergy side, and you can count on us to be working those very hard. We're just starting the integration process.

We do have a lot of growth opportunities, you can see in our guidance that we are investing still in a lot of those. Those investments show up in cost of goods sold as well as in SG&A. Some of those investments, for example, in Pharma Services, we're investing outside the U.S. We're putting up a lab in Singapore. We're still significantly under capacity in Geneva. We're working very hard to increase our commercial organization outside the U.S., and these things take time, they're important investments for us. In the U.S. here, we're investing a lot in the clinical business. We're investing in our quality management processes in order to meet the standards, the stricter standards for documentation and other things by the FDA. There's a lot of growth investments in our projections, in our numbers.

Kevin Ellich
Analyst, Craig-Hallum

Got you. That's helpful. Thanks for all the color, Doug. Congrats on the good quarter again.

Douglas VanOort
Chairman and CEO, NeoGenomics

Thank you, Kevin.

Operator

Thank you. Our next question comes from the line of Drew Jones with Stephens Inc. Please proceed with your question.

Drew Jones
Analyst, Stephens Inc.

Thanks. Good morning, guys

Douglas VanOort
Chairman and CEO, NeoGenomics

Great.

Drew Jones
Analyst, Stephens Inc.

Thinking about that same topic of mispriced tests. I know, with IHC PD-L1, that's obviously an area that could be focused on. I'm curious, what's your reception when you talk to your hospital customers specifically? Maybe what's the timeline to enact change with those contracts versus maybe commercial payers?

Rob Shovlin
President of Clinical Services Division, NeoGenomics

Yeah. Hey, Drew, it's Rob Shovlin here. I think, on the IHC example, in particular, we've had an effort to raise or increase prices on PD-L1 specifically, because of the demand for that test and higher cost of goods for that test. I think we've been pretty successful across the board at increasing pricing on that, and I think clients understand that and get the explanation behind it. In addition, we have a lot of discipline around our price approvals process internally, with our controls. We continue to be focused on price discipline as we move forward with our growth initiatives.

Drew Jones
Analyst, Stephens Inc.

Okay. Maybe shifting to Pharma Services. Doug, you mentioned the companion diagnostic, that seemed new to me. Can you give us any more color on that? Is that a new drug? Is it an already approved drug, maybe with an expanded indication that you're looking at, or any color there would be appreciated.

George Cardoza
President of Pharma Services Division, NeoGenomics

No. This is a test actually that was on our menu. It was a laboratory-developed test. Right now they're using that in their phase III clinical trial. It will be a companion diagnostic ultimately for their drug, ultimately, hopefully when it's approved, in 2019. Again, we're very uniquely positioned in the pharma, at NeoGenomics with the Pharma Services division. We can work with the sponsors upfront, and then what makes us attractive to them is we can also offer it day one on our commercial menu and have it available for ordering. That's really a value proposition that's very attractive to the pharmas.

Douglas VanOort
Chairman and CEO, NeoGenomics

That was George Cardoza, by the way, Drew.

Drew Jones
Analyst, Stephens Inc.

Thanks, George. Just to be clear, George, it sounds like that FDA approval could maybe come in front of the large panel.

George Cardoza
President of Pharma Services Division, NeoGenomics

Possibly.

Douglas VanOort
Chairman and CEO, NeoGenomics

Yes, because of the nature of that, yes, it probably will.

Drew Jones
Analyst, Stephens Inc.

All right. Thanks, guys.

Douglas VanOort
Chairman and CEO, NeoGenomics

Thank you, Drew.

Operator

Thank you. Our next question comes from the line of Puneet Souda with Leerink Partners. Please proceed with your question.

Puneet Souda
Analyst, Leerink Partners

Yeah, thank you. Hi, Doug. Congrats on the quarter.

Douglas VanOort
Chairman and CEO, NeoGenomics

Thanks.

Puneet Souda
Analyst, Leerink Partners

Let me touch briefly on, cost per test. Just wanted to get a view from you now with Genoptix, having a wider geographic base here. Maybe just give us your view on how cost per test can evolve further and decline further with your existing base of fixed costs that you already have in place. Also give us a view on the turnaround time, if that can improve here, for the oncologist and pathologist.

Douglas VanOort
Chairman and CEO, NeoGenomics

Yeah. Thank you, Puneet. We were pleased with the 6.6% decline in cost per test in the quarter. As you know, we've had a history of successfully reducing our cost per test, and really it's a lot of things. It's not one thing. First, it's scale and volume. Volume does come in at variable cost for the most part. That helps drive down cost per test. Importantly, we're spending a lot of money in IT and a number of automation initiatives. I mentioned the QMS, quality management system process. Ultimately, the QMS process, we believe higher quality results in lower cost because you're taking waste out of the system. We're working hard on automation, process enhancement initiatives, all of those kinds of things, just to continually drive down the cost per test.

I think that with the Genoptix acquisition, we have an opportunity to continue that trend, particularly on the volume side of the equation, adding volume to existing facilities. That gets into your last question about turnaround time. Ultimately, what we want to do is we want to use and leverage the infrastructure that we have here, such that East Coast United States clients are being predominantly served from our East Coast facilities. West Coast clients are predominantly being served by our West Coast facilities. Right now, we're sending samples across the country, and that has limitations on the progress that you can make in turnaround time. I think that, over time, we expect to have improvements in our quality, service, turnaround time, and cost per test as a result of our strategies.

Puneet Souda
Analyst, Leerink Partners

Okay, thank you. Then, on multi-gene panel, just wanted to get what should we be expecting next and the type of updates we should think through into 2019? Also, if you could, just on a high level, give us some thoughts on the overall liquid biopsy as a multi-gene panel. We recently saw that one of the tests received an LCD there, and there was a company that came to public market. Just wanted to get a view on liquid biopsy as a modality despite tissue being very much of a standard among the oncologists for multi-gene today.

Douglas VanOort
Chairman and CEO, NeoGenomics

Yes, Puneet. Let me just say, relative to that question, liquid biopsy is an exciting area for us, and it's an exciting area really for cancer patients and for oncology generally. I think most people on the phone might recognize that liquid biopsy is becoming increasingly important because of advances in next-generation sequencing technology. We have had and continue to offer a liquid biopsy test for heme cancers. That test has been on our menu for some time and is continuing to gain traction. There's a lot of investor interest today in liquid biopsy for solid tumor testing. There are more solid tumor cancers than there are heme cancers in the U.S., and there's been a lot of interest recently because of the IPO that you mentioned. Certainly that company has done a nice job advancing the science.

Liquid biopsies for solid tumors today are used really for advanced cancer patients. I would say that it's a very important technology because cancer patients, particularly, in the future, as cancer becomes more of a chronic disease, there'll be more monitoring of cancer and the cancer progression. It's much easier for a cancer patient to have that monitoring performed through a blood draw as opposed to a biopsy. This is an important technology. NeoGenomics has a limited offering today for solid tumor liquid biopsies, but you can be sure that this is on our radar screen. We are looking at it. We can approach this in a number of different ways, including investing in the technology ourselves, which we are doing, working with IVD companies, and there are a number of them working on liquid biopsy tests and offerings.

We could partner with other labs, or we could do a combination of all three of those things. I would say the last point is with Genoptix now in our scale, we do have unparalleled access to the channel to be able to offer liquid biopsy testing, whether it's heme or solid tumor, and we think we're in a unique position to do that.

Puneet Souda
Analyst, Leerink Partners

Thanks for the color. Thanks.

Douglas VanOort
Chairman and CEO, NeoGenomics

Thanks.

Operator

Thank you. Our next question comes from Joseph Munda with First Analysis. Please proceed with your question.

Joseph Munda
Analyst, First Analysis

Good morning, Doug, Sharon, and Bill. Can you hear me okay?

Douglas VanOort
Chairman and CEO, NeoGenomics

We can, Joe. Thank you.

Joseph Munda
Analyst, First Analysis

First off, I'd like to drill down a little bit on Genoptix. As we're building out our models going out to 2019, in some cases 2020, can we get some sort of color as far as price per test and gross margin profile that Genoptix has? It'd be very helpful.

William Bonello
Chief Strategy and Corporate Development Officer and Director of Investor Relations, NeoGenomics

Hey, Joe. This is Bill. We will give you additional color on that over time. I think as we noted on the Genoptix call last week, one of the issues is that the test count at Genoptix and the test count at NeoGenomics is not exactly apples to apples, and we're very reticent to give you data prematurely that might confuse things rather than clarify things. Once we have that sorted out a little bit better, then we will provide that information. Obviously, after the deal closes, we'll be providing historical results for Genoptix, and you'll see a lot more of that information as well. If you would just bear with us for now on that front, it would be a great help.

Joseph Munda
Analyst, First Analysis

Sure. I guess then we could expect something maybe when the deal closes, some sort of direction.

William Bonello
Chief Strategy and Corporate Development Officer and Director of Investor Relations, NeoGenomics

Yeah

Joseph Munda
Analyst, First Analysis

Is that the case? Okay.

Sharon Virag
CFO, NeoGenomics

After the deal closes.

William Bonello
Chief Strategy and Corporate Development Officer and Director of Investor Relations, NeoGenomics

Yeah, after.

Joseph Munda
Analyst, First Analysis

Okay, sure. My follow-up here, you guys gave us some great commentary on the backlog, talking about the synergies with PPD. I was just wondering two things. If you could give us some semblance or the contribution to the backlog from PPD as well as, Doug, you talked about the FDA and the encouraging meeting that you guys had. I guess, can you walk us through what the next steps would be going forward?

Douglas VanOort
Chairman and CEO, NeoGenomics

Sure, Joe. We're going to ask George to take the backlog question. I'll try to address your question around the FDA.

Joseph Munda
Analyst, First Analysis

I know I snuck one in there, an extra one.

William Bonello
Chief Strategy and Corporate Development Officer and Director of Investor Relations, NeoGenomics

Well done. You went over quota.

George Cardoza
President of Pharma Services Division, NeoGenomics

Yeah. Relative to PPD, again, we announced the alliance on June 1st. In July, we got the operational teams and the IT teams together to try to work together so that we had smooth handoffs and we actually could present an integrated offering. As we discussed too, the two teams have literally just come together on the commercial side and have really begun planning. We have done several joint bids. We've got a couple of small wins to date, but at this point, so far, as expected, I think it's had a minor impact in our numbers now, but we still remain very optimistic about the long-term future for the alliance.

Douglas VanOort
Chairman and CEO, NeoGenomics

Yeah, we're just getting started on that one, Joe. The question that you snuck in around FDA, let me say, first of all, that we're happy with the progress that we're making on this. We did, as I mentioned, have a pre-submission document. We met with the FDA. We found them to be very engaged in our process. I would say we're making progress on two fronts. First is establishing sort of an FDA-compliant process in our laboratories, and that's to meet the FDA's more rigorous documentation standards as opposed to CLIA. We're making progress on that front. The second area we're making a lot of progress on is on executing the assay development and the validation process itself. We're in the beginning phases of that, but we're making good progress.

I would say, it's hard to give you an exact date when we will finalize our submission, because this is a new process for us, and frankly, it's a new process for the industry. I would say that we're on track for a submission probably sometime in the fall.

Joseph Munda
Analyst, First Analysis

Okay. Thank you.

Operator

Thank you. Our next question comes from the line of Paul Knight with Janney Montgomery Scott. Please proceed with your question.

Paul Knight
Analyst, Janney Montgomery Scott

Hi, Doug. Congratulations on the quarter.

Douglas VanOort
Chairman and CEO, NeoGenomics

Thanks, Paul.

Paul Knight
Analyst, Janney Montgomery Scott

Could you talk about Pharma Services? How's the relationship with Covance? Could you talk about your level of backlog and just how is the Swiss facility? Is it capacity now? Could you give us a roundup on that part of the business?

Douglas VanOort
Chairman and CEO, NeoGenomics

Sure, Paul. Let me take a crack at it, and then we'll ask George to fill in the blanks here. We're very excited about our pharma business, and we've been investing in it. We've been investing in the infrastructure. George has taken over leadership of this probably six or seven months ago. He's doing a terrific job building out the team. The backlog, as you saw and we reported today, is up some 75%. That's all very promising for the future. The relationship that we have with a CRO is with PPD. It's, I think, a relationship, as George described, which is just beginning. We really like those folks. Their culture is terrific. We're working very collaboratively together, but we're at the beginning stages of building our backlog as a result of that relationship.

The other thing I would say is the Swiss facility is a very good facility. We're up and running. The instruments have been validated. We're running samples through that facility, but it's still way under capacity. We have a lot of room for growth there. We've just begun to build our sales team outside the U.S., and it takes time to get traction in a new marketplace. We're encouraged about the activity there, and we're encouraged also about having a facility in Singapore, because having worldwide presence in this business really helps the U.S. business as well as business in those geographic areas.

Paul Knight
Analyst, Janney Montgomery Scott

Is Singapore opened?

George Cardoza
President of Pharma Services Division, NeoGenomics

No. The first employees are starting in the first week of December, and we hope to be operational in early Q1.

Paul Knight
Analyst, Janney Montgomery Scott

Okay. Thank you.

Douglas VanOort
Chairman and CEO, NeoGenomics

You're welcome. Thanks, Paul.

Operator

Thank you. Our next question comes from the line of Brian Weinstein with William Blair. Please proceed with your question.

Andrew Brackmann
Analyst, William Blair

Hi, guys. Good morning. This is actually Andrew on for Brian this morning. I appreciate the commentary on the double-digit growth across the different categories that you noted. Could you maybe be a little bit more granular on what you think is driving that? Thanks.

Douglas VanOort
Chairman and CEO, NeoGenomics

Sure, Andrew. Let me take a crack at that and maybe we'll turn it over to Rob for the real facts. I would say that the growth We've been driving growth in our Clinical Services business for quite some time, as I think you know, and we just have a terrific sales team. Our service is good. Our customer service is great. We have a lot of word of mouth as a result of high customer satisfaction scores. We're continuing to have access to more hospitals as a result of our group purchasing organization these big hospital GPO agreements that Rob and his team continue to drive. There are a lot of things that are adding to growth and we think that that's going to continue. Rob, do you have something?

Rob Shovlin
President of Clinical Services Division, NeoGenomics

I would just add that I think our Clarient acquisition from three years ago gave us that real national scale and footprint to credibly deliver on these national agreements. We've had a lot of success, as Doug mentioned, not only with the GPOs or managed care plans, large hospital systems that may have 50, 60, 70, 100 hospitals across the country. Those contracts have helped fuel the growth pipelines for our individual sales territories as the reps focus on implementing those contracts. Also this year, we invested in some growth in the oncology practice segment and have had some beginnings of success there leading up to now this Genoptix acquisition.

Andrew Brackmann
Analyst, William Blair

Great. Thanks. I think in the past you've talked about the flattish PD-L1 volumes. Maybe you could talk about the trends in that category as well. Thanks, guys.

Rob Shovlin
President of Clinical Services Division, NeoGenomics

This is Rob again. We've seen PD-L1 spike in the early part of last year, and it's really flattened out over time. We see pretty consistent PD-L1 volumes each quarter for the last several quarters.

Douglas VanOort
Chairman and CEO, NeoGenomics

I'd just add that I think what PD-L1 did for NeoGenomics, in addition to being able to provide good testing for patients for this whole new class of immunotherapies, it's allowed us to be a leader in immuno-oncology generally. We've developed an offering, whether it's tumor mutational burden or MSI or whatever, I think we're looked to as people that know the testing protocols and have the capabilities in immuno-oncology generally.

Andrew Brackmann
Analyst, William Blair

Thanks.

Operator

Thank you. Our next question comes from the line of John Hsu with Raymond James. Please proceed with your question.

John Hsu
Analyst, Raymond James

Good morning. If we could start off with guidance, I just wanted to take your temperature on your confidence in mid-teens volume growth. I think you have a relatively difficult comp in the 4Q. Similarly on Pharma Services, 3Q was obviously a nice record level of revenue. How should we think about the trajectory as we look into 4Q?

William Bonello
Chief Strategy and Corporate Development Officer and Director of Investor Relations, NeoGenomics

Hey, this is Bill. Our mid-teens volume growth, again, is a trend over time. Some quarters will be above that, some quarters will be below that. We never give specific volume guidance for an individual quarter. I would say the same thing with the Pharma revenue. Our 20% plus long-term growth guidance for revenue is a trend over time. Remember that the Pharma Services revenue is still small enough that it can be variable from quarter to quarter. This quarter, we had a record quarter, but 21% growth because we had a great quarter in Q3 of last year. That's going to fluctuate a little bit as well. We probably can't give much more specificity in terms of Q4 specifically than that.

John Hsu
Analyst, Raymond James

No worries. That's helpful. Quickly on Genoptix, what are some of the integration activities that can be done before the deal is closed? Specifically, how are you thinking about customer attrition and what efforts can you do to keep that low? You obviously did a nice job with Clarient, so any learnings there on the customer attrition side? Thank you.

William Bonello
Chief Strategy and Corporate Development Officer and Director of Investor Relations, NeoGenomics

Yeah, John, we're working already on the integration, frankly. We have a number of weeks here before the deal closes. We've organized, or we are organizing as we speak, teams across a number of key areas. We have a steering committee organized. These teams are comprised of people from both companies, from Genoptix as well as from NeoGenomics. The process is pretty rigorous. Each team has a charter and objectives. There are day one activities laid out. There are things that we can do pre-closing and after closing. Obviously, there's a lot of information that we can't get from Genoptix pre-closing because of regulatory rules. There are some things that we can do. We can certainly get to know each other and start to plan out all of those integration activities.

Our objective is at closing, everyone will know exactly what needs to be done, either to gather more information or to develop plans very quickly. We'll hit the ground running. Last thing I'd say is we did some things very well with the Clarient acquisition. We did some things that we would change next time. We're putting all of those learnings together as we approach this one. One of the goals that we have, we have a number of goals. One goal is not to lose one single client. We're very pleased with the Clarient acquisition that that was the case. Other than very, very minor clients as a result of other things, we really didn't lose any clients as a result of the integration. That would be our objective this time as well.

Sharon Virag
CFO, NeoGenomics

Maybe I could add one more thing, John, if you wouldn't mind, to that. I think when you, maybe this is even going back to Kevin's question, our first question earlier on Genoptix. When you think about some of the integration and some of the synergy opportunities on the revenue side, I think there are a lot of positives we can do for revenue synergies. There's also a very strategic piece here, which is how do we make sure that as we move into that second channel, we do it in a really thoughtful way that focuses on our customers and our existing customer base in pathologists. We're going to be super careful. I think you'll see that Rob and his team are already being very thoughtful with the folks on the Genoptix side to figure that out.

Before anybody gets too excited about additional revenue synergies, you should know that we're working very hard to put together a strategic approach that is thoughtful for that client base and that there might be some additional compression that comes against that revenue synergy. Make sure that you're keeping expectations at a reasonable level so that we give the room for those commercial groups to work together, form those partnerships with the pathologists and in the communities. I think the integration work has already started for them to think through how do you best manage any channel conflict. Let's make sure we keep our expectations for revenue in Genoptix at the range that we've already given you of $85 million, because I think we need to give them the space to be really thoughtful in the integration.

John Hsu
Analyst, Raymond James

Okay, great. Thanks for all the color.

Operator

Thank you. Our next question comes from the line of Bruce Jackson with The Benchmark Company. Please proceed with your question.

Bruce Jackson
Analyst, The Benchmark Company

Hi. Congratulations on the great results.

William Bonello
Chief Strategy and Corporate Development Officer and Director of Investor Relations, NeoGenomics

Thanks, Bruce.

Bruce Jackson
Analyst, The Benchmark Company

Most of my questions have been answered, but I just want to ask a housekeeping question about the share count. You put out an annual share count target. What's the share count range for the fourth quarter that we should be looking at on a basic and fully diluted basis?

Sharon Virag
CFO, NeoGenomics

Yeah. I think we're at, again, this is our weighted average. 93 million for Q4 is expectation. The average for the year, 94.5 million.

Bruce Jackson
Analyst, The Benchmark Company

Okay. All right. That's it for me. Thank you.

William Bonello
Chief Strategy and Corporate Development Officer and Director of Investor Relations, NeoGenomics

Okay, Bruce. Thanks.

Douglas VanOort
Chairman and CEO, NeoGenomics

Thank you, Bruce.

Operator

Thank you. There are no further questions at this time. I would like to turn the call back over to Mr. VanOort for any closing remarks.

Douglas VanOort
Chairman and CEO, NeoGenomics

Okay. Thank you, Michelle. Before we end the call, I want to take a moment to recognize the approximately 1,078 NeoGenomics team members around the world for their dedication and commitment to building a world-class cancer genetics testing company. On behalf of our whole NeoGenomics team, I want to thank you for your time joining us this morning. For those of you listening that are investors or are considering an investment in NeoGenomics, we thank you for your interest in our company. Goodbye.

Operator

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.