Douglas VanOort - Chairman of the Board of Directors and Chief Executive Officer Steven Jones - Executive Vice President, Finance George Cardoza - Chief Financial Officer Steven Ross - Chief Information Officer Jerry Dvonch - Director, External Reporting Maher Albitar - Chief Medical Officer and Director, R&D.
Matt Hewitt - Craig-Hallum Drew Jones - Stephens JP Young - William Blair Debjit Chattopadhyay - Emerging Growth Equities Jack Wallace - Sidoti Mark Zinski - Uniplan.
Greetings, and welcome to the Neogenomics' first quarter 2014 financial results conference call. (Operator Instructions) I would now like to turn the conference over to your host, Doug VanOort. Thank you. Mr. VanOort, you may begin..
Thank you, Brenda. Good morning. I'd like to welcome everyone to Neogenomics' first quarter 2014 conference call, and introduce you to the Neogenomics team that is here with us today.
Joining me in Fort Myers, we have Steve Jones, our Executive Vice President for Finance; George Cardoza, our Chief Financial Officer; Steve Ross, our Chief Information Officer; and Jerry Dvonch, our Director of External Reporting; Dr. Maher Albitar, our Chief Medical Officer and our Director of R&D, is joining us from our Irvine, California lab.
Before we begin our prepared remarks, Steve Jones will read the standard language about forward-looking statements..
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 statements speak only as of today, and we undertake no obligation to update any such statements to reflect events or circumstances after today..
Thanks, Steve. We'll begin our call today with some brief remarks about performance in the first quarter of 2014, then provide an update of some key objectives, and finally comment on expectations for the remainder of the year. Steven will then discuss our financial results in more detail. Neogenomics performed well in the first quarter of 2014.
Underlying trends are very solid and we continue to invest our time and money in the pursuit of very exciting growth initiatives. Volume growth again exceeded 20% compared with last year's first quarter. Revenue growth was 16%.
Despite a $700,000 reduction in revenue recorded for the still unresolved National Correct Coding Initiative, or NCCI, relating to the billing for Medicare FISH test. We recorded a slight profit even with an accounting for the full impact of the new NCCI guideline. Overall results were close to the top-end of our guidance.
It wasn't exactly an easy quarter. Bad whether affected our revenue, the NCCI issue significantly affected Medicare FISH reimbursement per test and we physically moved every element of our lab facility in Port Myers, Florida. Despite those challenges, we were pleased to deliver solid quarterly results.
We continue to take market share and we're particularly pleased with the underlying trends in clinical testing volume. These strong results were driven by good performance by both our sales and operating teams. In addition, continued to be an important factor driving our performance.
Revenue from new products launched in the past 2.5 years, represented about half of our growth in the quarter. Molecular volume increased by 37% compared with last year and now represents our second largest testing department. However, it's noteworthy that we had growth in every major testing area and from every region of the country.
Once again, we were pleased that incremental profit was strong. Gross margins were 48%, an increase of 160 basis points from the first quarter of last year, despite the impact from the accounting to this new NCCI guideline.
Even at that level, we drove 58% or $1.5 million of the incremental $2.5 million of revenue on a year-over-year basis to the gross profit line.
Cost per test declined by about 7% compared with last year's first quarter and productivity metrics similarly improved, as the number of tests processed per lab employee increased by almost 12% in the first quarter compared with last year.
During the quarter, we completed about 75% of the activities involved with the full overhaul and renovation of our Port Myers lab. It's a challenge to get productivity and process improvement gains, while moving, and satisfying the daily demands of our clients, but our people did an outstanding job and achieved both.
Operating cost remained in good control, but increased as a result of a deliberate decision to invest in key growth and productivity initiatives. We increased sales and marketing expense by 36%, as we expanded our sales team.
We also invested to expand capacity, build an infrastructure and capability for clinical trials, develop our next generation sequencing platform and develop our new NeoSCORE prostate cancer test. It's not really our style to give excuses or to do subtractive analysis, but please humor me this one time.
If not for the NCCI matter, which we have accounted for and what we believe to be a conservative basis, we would have had a very strong quarter. Revenue would have been up nearly 21% and gross margins would have been nearly 50%. I tell you that, not just to get it off my chest, but to let you know that this issue is still unresolved.
I'll comment on this more in a couple of minutes. In our last investor call, I described our key areas of focus for 2014. We're making good progress in achieving these objectives and this morning I'll comment on just a few of these. One of our key areas of focus for 2014 is to get lean.
A core principle for us is that high quality and low cost go hand-in-hand. As a consequence, we attack cost by focusing on process improvements, automation, best practice initiatives and better information systems. As a result, we've been able to drive our quarterly average cost of goods sold per test down by over 24% over the past three years.
We continue to invest in information technology and to add resources to develop and implement projects to improve work flow. These include improvements in online ordering, barcoding, specimen tracking and other tools to create a streamlined, seamless and efficient lab.
We are managing these projects with increased rigor, because of their importance to our cost structure, and we expect to realize gains from these activities as the year progresses. We also installed new and exciting FISH in cytogenetics automation equipment as part of our Florida lab renovation.
This new state-of-the-art equipment is designed to reduce supplies cost and improve efficiency and should be fully operational some time during this second quarter. Getting lean also includes a lot of blocking and tackling.
Our people continue to work on best practice teams, execute lean initiatives and constantly develop better ways to improve quality, while reducing cost. Our goal is to leverage these activities to reduce our cost per test during 2014 by another 8% to 10%. I believe we will be successful in reaching this goal.
Growth is obviously another key focus area for our company. We've targeted a 20%-plus growth in volume again this year, and I see no reason why we shouldn't achieve that. It may fluctuate some quarter-to-quarter, but we feel comfortable with the 20%-plus annual growth volume target both this year and next.
We further expanded our sales team over these last few months. This investment in growth increased our first quarter cost, but we believe the investment is well worth it. We've been fortunate to continue to attract and retain some of the very best sales professionals in our industry.
Including regional managers, we ended the first quarter with a high-quality group of 27 field professionals on our sales team. And we're hoping to add three to four more over the next few quarters. We've also added sales training and product management resources to help our team achieve and maintain high levels of productivity.
The team is already quite productive. Our new client activity has been strong and the pipeline of likely new accounts is as strong as I have ever seen it. Recently, we've been awarded a number of large new accounts, including a large national pathology company, a large hospital systems and a large cancer center.
In addition, we also disclosed in 8-K filing this morning, the renewal of our contract with Florida Cancer Specialists. One of the largest oncology groups in the country.
We've had the good fortune to serve FCS for over 10 years now, and although they plan to perform FISH testing themselves, we have contracted to provide cytogenetics, molecular and any other genetic test that they don't perform themselves. We're looking forward to continuing to serve this important oncology group client.
New products continue to be an important driver for growth. Nearly 20% of our revenue or $3.5 million was realized from products introduced during the past 2.5 preceding years. In fact, 56% of our year-over-year growth was from these new products.
Among the new products launched during the quarter were, a new molecular test for Calreticulin mutation, a 48 gene next generation sequencing test for solid tumors and a 14 gene next generation sequencing test for myelodysplastic syndrome or MDS. We're gaining market share for a number of reasons.
Clients like our new products and comprehensive service offering, because it allows us to be a one-stop shop and because our service is consistent and reliable. Our core cytogenetics FISH flow cytometry and molecular testing services provide the most comprehensive accommodations of technical only and global testing services in America.
We are not gaining market share by offering low prices. We maintain a disciplined pricing policy and even though some competitors do compete on price, we've won in many competitive situations and we have very high retention levels for our customer base.
As we described in our last investor call, we are diversifying our business to balance our risk profile and take advantage of new opportunities to ensure that we can prosper even in difficult reimbursement environments. One of our important initiatives to diversify is in clinical trials.
As you know, we have been working with Covance's Central Laboratory as part of the exclusive alliance between our companies. As part of this alliance, Neogenomics will soon provide comprehensive anatomic pathology, histology and specialty lab testing services for worldwide clinical trials.
During the quarter, we invested to build our capabilities for clinical trials. We've hired people, built a small lab within a lab for Covance, as we seek to integrate our capabilities, and are looking forward to expanding these capabilities globally at Covance locations in Shanghai, China and Geneva, Switzerland, later this year.
We've also begun some commercialization activities. It's early in the process, but we've had more conversations with biopharmaceutical companies in the past quarter than in my entire five year tenure with the company.
In the past five months, we've won seven projects of varying sizes, ranging from immunohistochemistry to FISH to next-generation sequencing, which we will begin this quarter. Our world-class molecular testing capabilities, in particular, are of significant interest to pharmaceutical firms.
We have a lot more work to do, but we write the business and we like our chances to compete in this clinical trials area. Our goal is to build a meaningful clinical trials business over the next couple of years and we're quite confident that we can make this happen.
Innovation offers us a number of interesting diversification opportunities and we are investing and pursuing them. Among the most interesting are the prostate cancer test and next generation sequencing. Development of prostate NeoSCORE, our proprietary new prostate cancer test is proceeding nicely.
As you may remember, this is a molecular test performed on blood plasma and urine, instead of prostate tissue biopsies. The two goals for this test are to diagnose the presence of cancer in patients with DTH and to distinguish high-grade from low-grade cancer in patients with prostate cancer.
We have scheduled two advisory board meetings in the next two months and are working on another paper to include data from 319 patients tested in our second round trial. We hope to present an abstract at the next meeting of the American Society of Clinical Oncologist or ASCO, and to make the test available for ordering in the next month. Dr.
Albitar and his team have been working very hard on this new test, and we believe it has very good commercial prospects relative to other prostate cancer test coming on the market. Next generation sequencing is evolving quickly, and we are working to deploy this powerful technology for both clinical testing and clinical trials use.
Over the next couple of months, you will see us convert more of our comprehensive molecular profiling tests to the next generation sequencing platform. Somewhat uniquely, Neogenomics has the ability to augment next generation testing with FISH and other testing modalities because of the breadth of our cancer test venues.
As reimbursement for this technology becomes more certain, we will have a very strong competitive offering in this area. Before I summarize my remarks, I will give you an update on the NCCI FISH edit matter.
As background, the National Correct Coding Initiative, a department within CMS, issued a new guideline in December of 2013, concerning FISH reimbursement that has created significant confusion in the laboratory industry. During the quarter, we tried very hard to help facilitate discussion between the industry and the NCCI.
As a result of a meeting on March 5, CMS allowed one comment letter from the industry to be submitted on the NCCI change. That letter was sent by the American Clinical Laboratory Association or ACLA on March 19, and we had a significant role in drafting it.
For those of you who are interested in reviewing this letter, a copy can be found through a link on the homepage of our website entitled, Recent NCCI Edits. At the March 5 meeting, CMS acknowledged that a clarification was needed and we are expecting a response from CMS shortly.
Although the initial guidelines issued in December are confusing, the absence of any clarification, we have chosen to build and account for this new NCCI guideline, in what we believe to be the most conservative interpretation in order to avoid any future problems, if there isn't a clarification, despite the fact that this results in a negative margin for certain FISH tests.
As you know, the impact of this was to reduce our revenue by approximately $700,000 in Q1 with substantially all of that revenue impact affecting net income and adjusted EBITDA.
If the NCCI guideline is reversed, as recommended by the entire lab industry, we will go back to bill and recover the money we are owed, and record the additional revenue in the quarter in which they announced the final decision. We will issue an 8-K as soon as we have clarity or any response from CMS on this key issue.
Notwithstanding the CMS uncertainty, I'll summarize my comments by simply saying that I had never been so excited about the possibilities for Neogenomics. We are growing and taking market share. We are getting leaner through good processed management and control and we are developing new products and businesses for the future.
Despite the pressure on our industry, our company is strong and we are focused on delivering great service for our clients and patients and creating strong value for our shareholders. I will now turn it over to Steve to comment more fully on our financial results..
Thanks, Doug. I'll start by reviewing some of our financial and operating metrics for the first quarter and then we will open it up for questions. First quarter revenue was $18.2 million, a 16% increase from Q1 last year. Test volumes increased by 21% and average revenue per test declined by 3.8% to $469.
The NCCI FISH matter reduced average revenue per test in the quarter by $18. Gross profit was $8.7 million, a 20% increase over Q1 last year.
As Doug discussed, we improved our average cost-of-goods-sold by about 7% versus last year by increasing lab productivity, realizing leverage from higher volumes and from a variety of cost containment initiatives.
This more than offset the 3.8% reduction in average revenue per test, which in turn allowed us to drive our gross margin up by a 160 basis points to 47.9% in the quarter from 46.3% in Q1 last year. Turning now to SG&A.
Total sales and marketing expenses increased by $700,000 or 36% versus last year as a result of investments and more sales and marketing personnel and the incremental commissions on the increasing revenue. General and administrative expenses increased by $879,000 or 21% versus Q1 2013. And R&D expenses decreased by $207,000 or 25%.
The decrease in R&D was primarily the result of unusually large non-cash stock-based compensation expense booked in Q1 last year. The core R&D spending did not decrease at all. Total SG&A and R&D expenses were up about $1.4 million or 20%, year-over-year.
Net income for the quarter was $102,000 or $0.00 per share compared to net income of $3,000 or $0.00 per share in Q1 of last year. Adjusted EBITDA was $1.7 million in the first quarter down slightly from last year.
We finished the fourth quarter with 339 full-time equivalent employees and contract doctors as compared to 320 at December 31 of last year. Our accounts receivable balance, net of allowance for doubtful accounts was $19.3 million at March 31, up approximately $600,000 from the balance at December 31.
Our AR balance express in terms of day sales outstanding was 95 days as of March 31 versus 94 days as of December 31. As we have discussed previously, we have been putting in a new billing system over the last two quarters, which has diverted significant attention away from the normal billing duties.
DSOs hit a high in January and have started to steadily decrease since then. Indeed, we had our strongest two months of cash collections in our history in February and March and we still believe that we can get DSOs down in the low-80s by yearend.
We had $5.4 million of cash on March 31 and $4.2 million of availability under our working capital line of credit for a total liquidity of $9.6 million. Our cash flow from operations in Q1 was positive $1.0 million. We purchased $2.6 million of property, plant and equipment in the quarter.
However, we were able to lease finance approximately $1.7 million of this amount, thus the net use of cash from investing activities was only $900,000. Turning now to the guidance we issued this morning for the second quarter of 2014.
Assuming, we continue to use the conservative interpretation in the NCCI FISH model, which as we've discussed is still unresolved, we expect second quarter revenue of $18.8 million to 19.3 million and $0.00 to $0.01 per share of net income.
A positive resolution of the NCCI matter would have the effective increasing revenue by approximately $700,000 for the quarter. In addition, a positive resolution will allow us to rebuild for approximately $700,000 of revenue that we elected not to do in Q1. Approximately 85% of any positive resolution of the NCCI issue would fall to net income.
As discussed in the press release, we are also increasing our guidance for the full year 2014. Previously, we stated that we expected revenue of $73 million to $77 million if the NCCI edit was result positive with the earnings of $0.05 to $0.07 per share.
We now believe that we can achieve $73 million to $77 million of revenue, even if the NCCI edit is not result positively and earnings to $0.03 to $0.05 per share. The net effect of this guidance change is to add approximately $3 million to our revenue guidance and $0.02 to $0.04 per share to our net income guidance for the year.
A positive resolution of the NCCI issue would have the effective increasing revenue by another $3 million and net income by approximately $0.04 per share on top of the above guidance. At this point, I would like to close down our formal remarks and then open it up for questions.
Incidentally, if you are listening to this conference call via webcast only, and would like to submit a question, please feel free to email us at sjones@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.
Operator, you may now open up the call for questions..
(Operator Instructions) And our first question comes from the line of Matt Hewitt with Craig-Hallum..
First question, I don't know if you have the ability to do this, but what was the weather impact? I mean you were kind enough to provide what's the growth rate would have been x NCCI, but had you not had a number of loss due to weather, what would your growth rate have been in that case?.
That's a difficult question to try to figure out exactly what you would have done if something else would have happened. I can tell you that our average number of test reported per day increased by 12% from January to March, which is a substantial acceleration of momentum during a quarter.
In fact, it's one of the strongest momentum accelerations we've ever had in a quarter. And we think a lot of that is because January was suppressed by the weather. I don't have a dollar revenue figure, but it was more than six figures..
And then regarding the recent SGR Fix, I'm wondering if you could provide us a little bit of detail on how you think that will impact your business going forward?.
Generally, we thought that was a positive. You have to look at -- I think Congress is sort of overriding CMS' plan to use technological change. And I think when you look at last year, their proposal was an 80% cut to certain tests. So I think moving to more of a market-based, I think it is a much fairer structure I think over the long rung.
So in the short run, fees are going to be stable. And then I think moving to a market rate, it's actually better than I think what CMS was proposing. And I think generally, we view it as a positive. In most of lab industry, I think it's a plus..
And assuming, it essentially takes some of the risk off the table with the upcoming CMS proposed rate cuts for 2015, July timeframe. But it doesn't take a lot of that risk off the table..
Well, keep in mind, Matt, that that only applies to the clinical lab fee schedule. Medicare is only 25% of our payer mix and the clin lab fee schedule is only about 20%, 22% of that. And so it actually is only applicable to a pretty small piece of our business..
We might prefer a structure that's kind of based on a market average than a structure that's based on maybe a bureaucrat's view of what technological change is and CMS hasn't always been transparent, so I still think moving to a market approach is a plus for us..
And maybe one more for me, then I'll hop back in the queue. As far as the clinical trial opportunity and the projects that you've been able to sign up, how should we think about average size of those deals? I mean are they several hundred thousand, are there some that are about $1 million per trial.
I'm just trying to get some sense for what that can mean for the business?.
Well, Matt, they are varying in sizes. So some are $100,000 and some are $1 million-plus. I think that we're going to get a lot more experience here in clinical trials over the next several quarters. And what we expect to happen is that we expect to keep wining new projects and these projects will have lives of varying life sizes as well.
So some can be completed in a matter of months, some are completed in matter of years. And so what will happen in the second half of this year is we expect to be managing a number of clinical trials and we expect the number that we manage to continue to increase.
And so I think we're pretty bullish on our ability to continue to grow our business as a result of a number of a trials from both Covance and from our ability to deal directly with the biopharmaceutical industry as we move forward..
And our next question comes from the line of Drew Jones with Stephens..
Diving a little bit further into the CRO relationship, you talked a lot about the flurry of RFP activity.
Have the RFPs had been awarded? Can you talk about your win rate?.
I think it's a little early to talk about win rates. And I say that because some of our activity, about half of the activity of RFPs, actually a little bit more than half has come as a result of our relationship with Covance. And we're still working on the process by which we work that relationship and understand wins and losses and so forth.
So we don't have a really good answer for you right now. I would guess that of the trials that we're bidding on directly, we have a little bit better sense, and I would say that that's so far around 50-50. We're a process-oriented company. So what we do, we don't take losses well, we like to win.
And so whenever there is an issue, we don't win, we go back and try to figure out exactly how we can win and we intent to try to have a very high level of wins for these RFPs..
And looking at the volume growth in the quarter, obviously, another good quarter there and March was strength. You talked a little bit about pent-up demand there.
Can you give us a peak at what percentage of the volumes came from Florida Cancer Specialists in March?.
The Florida Cancer Specialists volume for March and really for the first quarter represented about 15% of our revenue. So for the whole quarter, Florida Cancer Specialists represented about $2.7 million of revenue for us. The acceleration in our revenue that Steve mentioned from 12% growth from January and March really occurred from new client wins.
So we are gaining new clients at even accelerated paces. And that's why we're fairly bullish and increased our guidance for the year..
And then last one from me, obviously, some sales additions are starting to bear fruit.
What percentage of the sales force would you say in running full speed right now?.
Well, I'll give you a sense for that. In March, I would say that about 70% of our sales team, I think I get this right, 70% of our sales team was at or above target. And we have pretty aggressive targets for them. It's been the same kind of targets and goals that we've had for a number of years and that's pretty good performance. It's accelerated.
Recently it wasn't bad in January, partly weather-related and so forth. But our goal is to have 75% of our representatives at or better than target for the year with 20% kind of growth. And at this point, I think that most of our sales force will be at that kind of level..
And our next question comes from the line of Amanda Murphy with William Blair..
It's JP in for Amanda. My first question is around the FCS agreement.
Could you guys talk a little bit more about the economics of the deal and kind of what made them come back to the table and sign the new agreement?.
As you know, I think we've had been privileged to serve FCS for a number of years now, probably about 10 years all-in-all. It's a very important relationship for us and it's been changing and evolving over that entire period, as we change and evolve and as they do. But right now they have more than 160 physicians.
They have built their business to be started as a leader in oncology in America. And they have a desire to perform more testing themselves and they have done this over the last several years. So as I said before in my remarks, we expect to perform less FISH testing for them, starting as soon as May of this year.
Now, our agreement extends through the end of 2015. It does have the annual renewal options. And during this time, we intend to perform all cytogenetics and molecular testing for them. And also to perform any testing that they don't perform themselves. I might add that, we are also collaborating -- Dr.
Albitar is collaborating with a number of their leading oncologist on some new test development activities. And so we're continually finding new ways to work together.
Now, in terms of the economics, I did mention in quarter one FCS represented about $2.7 million of our revenue, about half of that is FISH, and we expect a lot of that FISH testing will be performed internally by FCS after May of this year.
Now, I will also add that we're fortunate to have enough momentum in the rest of our business, which is accelerating, and we expect to more than offset this FISH volume loss with clients, who have already begun to use us and/or with clinical trials revenue.
One thing I'd add, JP, is that the guidance increase that we made this morning, does not reflect any increase from the contract renewal by FCS, because we expected to retain that business, when we issued our full year guidance a couple of months ago..
And then, do you have any insight into maybe other competitors have, speaking about insourcing or is that kind of a one-off deal there?.
Well, I'd tell you that we are continuing to work on this kind of model, where we -- we have a very flexible business model, and that's one of the keys to our success. As you know, we can perform the technical component of global testing. We can do a little bit of each.
We serve many clients both pathology clients and oncology clients today, who have chosen to perform some testing themselves and use us for testing that they don't perform. I think it's a mixed bag in terms of who is insourcing and who is outsourcing.
I will say there is a bit of both from a number of hospital clients, so a number of these are saying, well, I don't -- not even makes sense for us to do flow cytometry anymore. On the other hand, we've just landed a nice oncology account where they are insourcing flow and using us for everything else.
So as the market changes, our clients change, we're trying to be very flexible to be able to serve a wide range of clients with varying desires..
And I might just add one thing on that, we're not hearing really from any of our other existing large clients any rumblings about insourcing current volume they have with us.
What we are doing is we are proposing and presenting to several large clients, partnership kinds of models where we help them bring up a certain portion of the testing and we do the rest of life test, new win from the oncology group that Doug just mentioned.
And so we don't actually see much pressure coming from the rest of our already established clients on the insourcing front. The FCS thing is sort of a unique situation. They are a very, very large client. And in fact, we believe they're the largest independently-owned oncology group in the United States.
And they have certainly the size and the scale to look at things a little differently than most clients..
And then if I could on the next-generation test, just curious how you guys are thinking about doing for those in the future and maybe who you're running into competitively with those tests?.
Billing for next generation sequencing is something that we're working very hard to get right. I think I would say before maybe Dr. Albitar or Steve way in here that we are trying very hard to lead in this area. There are number of companies that have lunched next-gen platforms and tests. There are different strategies.
Our strategy has been to look at driver genes. We have couple of different next-gen tests right now. We are going to add significantly to the number of next-gen test that we perform. And Dr. Albitar, you may want to comment a little bit on what our general strategy is on next generation sequencing.
And then George or Steve, if you have some further comments on reimbursement that, would be great..
So as Doug said that our strategy is more concise as well as conservative strategy. For example, as we discussed this before, when you are dealing with lung cancer core biopsies, you have very scanned small samples.
As a matter of fact, we currently, these samples, because of the material are very scanned and the tumor might be very small and bulging, 5% or 10% of that samples, very difficult to get complete, if that duration for molecular abnormalities, in particular, EGFR and KRAS and BRAF, which are very important for making decision how to treat these patients.
So even for one test, let me say, in the EGFR, some times we select to use next-gen sequencing for testing and we believe that it is more accurate than any other testing available currently, and we believe it should be build as the same way as a conventional symptom sequencing or BCR-based testing.
So with that attitude, I think we feel very comfortable we would be able to get reimbursement for next-gen sequencing and we are trying to have a bit of composition as well as educate the [ph] bureaus about this concept..
And our next question comes from the line of Debjit Chattopadhyay..
I'm just trying to drive a little bit more clarity on the Florida Oncology Group situation here. So last year there were about $12 million in revenue and if FISH is 50%, so it's going to be more like $6 million for the whole year, but they're also fairly large practice.
So are there volume growth comparable to your kind of volume growth, in which case you're looking at between $7 million to $8 million in revenue from that practice this year..
Last year there were just over $10 million in revenue, not $12 million in revenue. About half of that was FISH. We expect to lose most of the FISH beginning after May 15. It will be phased in over time. If you look at where the trends are in this account, they tend to purchase a lot of oncology practices every year.
In fact, I believe they something like tripled or quadrupled in size in the last three or four years just through acquiring more practices.
We don't have any color or insight as to whether they'll keep doing it, but absent anything to the contrary, we would assume that they will keep growing their own internal practices, and so we'll lose a good portion of the FISH, maybe even most of it. We think we'll continue to get growth from Florida Cancer as they continue to grow.
And as to what the total loss of revenue will be this year, we haven't really scoped that all out yet, but it's not going to be as bad as what it otherwise would have been, because we're going to retain all the cytogenetics molecular and all the other testing that they don't otherwise elect to do.
And just to give you a sense of that, we do a lot of overflow float cytometry testing for them today, because some times it will have capacity issues and what not.
And so we become effectively in the safety net for them and we can pick up wherever they want to leave off, and that's a very powerful feature and a very big competitive advantage that we offer. Indeed that's why we're getting so much interest in these kind of partnership-driven models from other clients..
So if you compare FISH, cyto and molecular, how does the margin stack up for the all three segments?.
Without respect to anyone client, generally speaking, FISH is sort of in 50%-plus range. Cytogenetics has always been a lower margin business, although we are getting ready to roll out some pretty interesting automation. So generally speaking across the whole Neo system, the margins in cytogenetics are somewhere in the order of 25% to 30%.
Molecular has been increasing quite rapidly each of the last four quarters. We expect to have molecular margins up into the 40% to 50% range by end of this year and maybe even higher..
Now switching to the prostate cancer, Steve, the second trial that was run with 319 patients did that include the samples from EU or that's a separate trial that's underway right now?.
Dr.
Albitar, you want to answer that? Do the samples in the second 319 patient trial include any samples from the European Union?.
No. Not yet..
I'm sorry, I did not catch that..
No. They did not. Not yet..
So you have separate trials running on samples coming in from Europe?.
Very much so, yes..
And just in terms of the regulatory strategy then, any thoughts on 510(k) filing or kind of running through a prospective trial on intra-using of prior biopsies and stuffs?.
No. the prostate cancer test will be launched as a laboratory developed test. There is well-established protocol for that in the testing arena. We'll validate it in lab that will be running it in which is our Irvine, California lab, we're actually well in the way to having already validated that.
And we intent to make it available as Doug mentioned some time in the next month for those that want to start ordering it..
And our next question comes from the line of Jack Wallace with Sidoti..
Just want to get a little bit more color on the volume growth. It seems like the maturity of those coming from new accounts.
One, where were some of those accounts added into the new territories? And two, you also mentioned that there was a nice pickup across the board use of the SPA test, how much of that came from current accounts as well?.
In terms of the volume growth, it was relative wide spread. So we have three different regions of the country from a management perspective. The western region is growing at a relatively higher pace, but it's a much smaller actual size for us. So we've leased up the number of representatives that serve us out and that are serving that market.
We also have a terrific lab, which Dr. Albitar keeps as office, and so that lab shows well and we're able to bring a number of clients there. So we've been growing there pretty nicely. Interestingly the central part of the country has been growing at a very high rate.
We actually include Florida in that region, its not exactly central, but that's how we manage it. And we've had pretty good growth, even here in Florida..
I actually have some data, just to kind of put a final point on this. Our growth and volume in the first quarter for non-Florida test, which would include everybody other than FCS and all our other Florida accounts was 24%, whereas the Florida growth was only 14%. So we're clearly growing faster outside of Florida than we are in Florida..
And in terms of the breakdown between new and existing accounts, were the existing accounts growing? It sounds like a little bit slower rate, but say, what was the other rate of the existing account growth rate?.
We don't actually get into disclosing that publicly, because there is so many assumptions you got to make to get to apples-to-apples and its something that's going to lead to more confusion than it's worth. But let's just say that we took a lot of additional market share away from existing clients, where we got a greater share wallet.
It usually takes 12 to 18 months to fully penetrate a client, and what we're finding as a result of the breadth and depth of our menu that we are growing quite nicely in same-store sales as well as in new clients.
And so you got to get it into making assumptions about what's an increasing same-store sales versus not same-store sales to get that question. We look at, but it's not something we really want to get into quantifying for the investment community..
And how many test were added in the first quarter?.
It's a very interesting question. If you count next-gen sequencing, 48 gene panel and next-gen sequence MDS panel as one test each, then we also added three other tests, calreticulin mutation analysis, [ph] SEBT1 and cMET, SETB1 mutation analysis and cMET mutation analysis. So I'm going to call it five, but I'm going to invite Dr.
Albitar to correct me..
Again, I think we are at stage where we are looking to add, developing more high-complexity testing, for example, we are focusing on the prostate cancer, which frankly is taking the tremendous efforts.
The next-gen sequencing panels, we are about to introduce multiple new panels, so we are focusing on this and remember, but way more higher impact testing..
And then, two last questions here.
One, how much of the operating expense in the quarter was non-recurring in nature? I guess how much of the OpEx that you're seeing or maybe even some of it's in the cost-of-goods, that won't be there once the lab in Florida is done being remodeled and other non-recurring charges?.
We look at that a one-time sort of related expenses embedded within OpEx, I guess construction and moving, we're capitalizing most of that..
It was relatively de minimis. And we had to move and help people move boxes and keep their equipment, but it wasn't a major number..
For those of you who have visited our Fort Myers facility before, you won't recognize it. It is completely remodeled. I can't emphasize enough not how much we've changed things and how excited we are about the impact that we'll make on our workflow..
And then lastly, you mentioned in the past that you'll be looking to go ahead and acquire other labs. So you filed a shelf earlier in the year.
Any developments on the M&A front and maybe comment on relative evaluations for other transactions this year versus last, x the capital, any of those considerations?.
Well, I would just say that we continue to have a lot of exciting conversations with potential partners that we might acquire. And, no, I really can't comment on evaluation..
And our next question comes from the line of Mark Zinski with Uniplan..
Just wanted to confirm a previous statement in the prepared remarks that you think that test volume growth for 2014 and 2015, can stay at that 20% level, is that correct?.
Yes. So just to clarify that a bit, so obviously, we have better visibility to the current year than next year. And I will also caveat that the volume growth can fluctuate quarter-to-quarter. But yes, we're comfortable with 20% volume growth. That's our target this year. And I think it will remain our target next year.
And we see no reason why we can't achieve it..
And then just to dissect your thoughts on gross margin going forward. It looks like you've brought some new equipment and you think you might have some lower supply cost going forward.
Do you see the future gross margin improvement coming mostly from those equipment purchases and investment in IT or can you still get some improvement from like process improvements and productivity et cetera?.
So Mark, the answer is really all of the above. We try to lump all of this into looking at improvement in average cost per test. We have been on record many times stating that we expect to get 8% to 10% average cost per test improvement this year. We were just under 7% in Q1.
There are five or six different things to drive that it's the automation, it's the productivity. It's just a sheer leverage from offering more tests to our fixed infrastructure. And although, we are increasing capital spending in the lab, the amount of incremental revenue we're pushing to that far outweighs the revenue.
So we think we can get back up into that 49%, 50% gross margin area by the end of this year. And that's before factoring in a positive or potentially positive resolution of the NCCI edit. If the NCCI edit is rescinded or otherwise favorably resolved, some 85% of that incremental revenue would fall to gross margin.
We don't even want to think about that. That's a little too crazy..
Could you potentially just kind of give a little example of the new equipment and the lower cost materials at all, any color on that?.
Well, I guess, I would just say that the -- and we have a lot of new equipment and a lot of information technologies. Steve Ross is here and he is helping us to do a much better job in automating a number of tasks that are currently manual in the lab.
One of the big pieces of equipment we just put in will help us to automate the, what we called the wet lab piece, the front-end part of the process for cytogenetics and FISH. And what it will do is allow more consistency in that process and a lower level of supplies applied to each test.
So anytime you automate, you free up resources that we can use for other areas. We're still having a hard time attracting, finding technologies in some of these areas. And so any automation that we can put as part of our process really helps us..
And our next question comes from the line of [ph] Frederick Hartley who is a Private Investor..
So happy to here about NeoSCORE and how that maybe made available to patients in the near future, and I was wondering if you can talk at all about the use of SVM to enhance the images for your cytogenetics and flow cytometry test?.
I think, Dr. Albitar is probably best to describe this as he has put a lot of time and effort into applying SVM to our laboratory processes. Dr.
Albitar?.
It's again, along that the same these of automations, we developed in collaboration with Health Discovery the SVM-based software to broaden the analysis of the cytogenetics and make it a little bit more automated. We finished the development of that software. We expect it to reduce the time that each one of our technologist needs to finish the case.
Remember cytogenetics, reading cases is extremely labor-intensive and an average cytogenetist can do two cases, two-and-a-half case per day. So if we can reduce the hours used by our technologists and considering the huge number of cases we do everyday, this will add up into significant improvement in efficiencies and improvement on our margin.
The software currently looks great. We are very excited about it, but we are doing some testing, making sure that the things on validation before implementing the software.
At the same time, we are using the cMET process for automation for interpretation and analysis of other kind of testing including flow cytometry as well as others as we go forward..
We have a couple of quick questions we've gotten via email, I just want roll through here. Would you please give us some more color on clinical trials business from pharmaceutical companies? What kinds of test are they looking for? What's the pricing strategy for this business compared to test for patients.
I would say, generally speaking, our discussions with biopharmaceutical companies are across the board. We tend to get a lot of increase about our molecular capability that's probably the most prominent thing that is being discussed.
But we have IHC and FISH and flow and other types of testing and even cytogenetics in the clinical trials business as well. The pricing for clinical trials is generally equal to or better than the best pricing we get in the clinical side of the business.
The parts of clinical trial, it's very important to have very good data controls and there is a premium that you get for the management aspects of the clinical trials. And so I would say, generally speaking, we feel pretty good about getting premium pricing for premium service in the clinical trials world. Got one other question here.
Does the company view NeoSCORE as a replacement test for PSA or a test when the PSA is questionable? PSA is actually an input to the NeoSCORE test. It's one or 12 or 13 different inputs that we'll use. We actually need to get the PSA reading in order to run test. And so it doesn't replace PSA, it augments PSA, Dr.
Albitar, you want to add anything on that?.
Exactly, like, how you've said it. It is to be used for patient who have a PSA greater than 4, it is to be used for patient who have BSA greater than 2.5, as we have family history of African, Americans. It is very much as a test what currently many people use as a liquid biopsy and things like this. So it is not replacement for PSA..
I think that's all the email questions. So as we end the call, I would like to recognize all 339 Neogenomics team members around the U.S. for their dedication and commitment to building a world-class cancer genetics testing program here.
And on behalf of our whole Neogenomics team, I want to thank you for your time and joining us this morning for our Q1 2014 earnings call. And let you know that our second quarter 2014 earnings call will be on or around July 22 of this year.
For those of you listening, there our investors who are thinking about investing in Neogenomics, we thank you for your interest in our company. Goodbye..
Thank you. This concludes today's teleconference. You may disconnect your lines at this time. And thank you for your participation..