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Edited Transcript of VIVO earnings conference call or presentation 30-Apr-19 2:00pm GMT

Q2 2019 Meridian Bioscience Inc Earnings Call

CINCINNATI May 3, 2019 (Thomson StreetEvents) -- Edited Transcript of Meridian Bioscience Inc earnings conference call or presentation Tuesday, April 30, 2019 at 2:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Eric S. Rasmussen

Meridian Bioscience, Inc. - Executive VP & CFO

* John P. Kenny

Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director

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Conference Call Participants

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* Andrew Frederick Brackmann

William Blair & Company L.L.C., Research Division - Associate

* Brian David Weinstein

William Blair & Company L.L.C., Research Division - Partner & Healthcare Analyst

* Catherine Walden Ramsey Schulte

Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst

* Mark Anthony Massaro

Canaccord Genuity Limited, Research Division - Senior Analyst

* William Robert Quirk

Piper Jaffray Companies, Research Division - MD and Senior Research Analyst

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Presentation

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Operator [1]

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Good morning. My name is Dennis, and I will be your conference operator today. At this time, I would like to welcome everyone to the Meridian Bioscience Fiscal Second Quarter Earnings and Strategic Acquisition Call. (Operator Instructions)

I will now turn the call over to Mr. Eric Rasmussen, Chief Financial Officer. Please go ahead, sir.

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Eric S. Rasmussen, Meridian Bioscience, Inc. - Executive VP & CFO [2]

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Thank you. Good morning, and thank you, everyone, for joining the call this morning. We hope you've been able to access both press releases through our 8-K filings this morning. We apologize as our newswire service has been down and unable to process these releases in the normal course. If you've not been able to access them, please go to the Investor Relations section of our website, where both press releases and this morning's presentation are available.

Before we begin today, let me remind you that the company's remarks include forward-looking statements. Forward-looking statements are subject to numerous risks and uncertainty, many of which are beyond the company's control, including risks and uncertainties described from time to time in the company's SEC filings. The company's results may differ materially from those projected, and the company takes no -- undertakes no obligation to publicly update any forward-looking statement.

Additionally, as indicated on page -- discussed on Slide 4, we'll refer to non-GAAP financial measures this morning, specifically operating expenses, operating income, net income and earnings per share. A reconciliation of these non-GAAP financial measures with the most directly comparable GAAP measures is included in our press release, which is, again, available on our website.

So with that, I'll jump straight into our second quarter results on Slide 5. As we reported earlier today, total revenues for the second quarter of fiscal 2019 were $50.2 million as compared to $56.7 million in the second quarter of fiscal 2018. This represented an 11% decrease in total or about a ten percent decline, excluding the impact of foreign currency exchange rates and was in line with the preliminary results we announced on April 2. This decline was driven by our Diagnostics segment, where revenues decreased about 16% as our Life Science business has essentially flat sales in the quarter.

Company gross profit margin declined 280 basis points during the quarter to 58% with some margin pressure in both our Diagnostics and Life Science segments. Product pricing, particularly for our H. pylori products, had an unfavorable impact [on our] margin in addition to the effect of volume and product mix in Diagnostics. While the business mix between immunoassay-related products and Molecular reagents in Life Science also had an unfavorable impact on the margin in the quarter.

On an adjusted or non-GAAP basis, second quarter operating income decreased to $11.2 million or 11% compared to $12.6 million a year ago. The decrease was driven by the sales decline in our Diagnostics segment although was somewhat offset by lower R&D and SG&A spending overall. The adjusted operating margin in the quarter was 22.3%, which was unchanged versus the second quarter of 2018.

Also on an adjusted basis, net earnings of $8.2 million in diluted dollars and diluted EPS of $0.19 per share decreased 8% and 10%, respectively.

On a GAAP basis, operating income of $9.8 million included acquisition transaction costs and litigation costs of approximately $1.4 million in this quarter compared to the combined litigation and restructuring costs of approximately $4.9 million in last year's results.

Turning to the next slide, Slide 6, and highlighting our operating segment results for the quarter, starting with the Diagnostic segment. As mentioned previously, Diagnostics revenues declined 15% to $33.5 million, significantly driven by competitive pressure in our molecular products, which were down 28%, most notably C. diff, which continues to experience significant volume declines.

Although expected and planned contractual price reductions in H. pylori implemented in 2018 also contributed to a decline in our overall gastrointestinal revenues, and later buying patterns for the January through March period of the 2018-2019 respiratory season contributed to a 21% decline in respiratory product revenues.

Our life care products continue to show a positive growth for the quarter. Operating expenses in our Diagnostics segment were lower during the quarter as a result of a number of factors. Organizational streamlining activities completed in 2018, our lower clinical trial cost compared to the same period last year and lower -- and materially lower quality system remediation costs for Billerica manufacturing facility as well as lower compensation costs for sales commissions and corporate incentive bonus.

In total, Diagnostics operating income decreased 30.4% to $7.4 million on an adjusted basis. Operating margins for Diagnostics in the quarter were 22%.

Now looking at our Life Science segment. Life Science posted a meaningful operating income improvement, nearly 50% despite the weaker-than-expected revenue growth as a result of the organizational streamlining activities completed in 2018.

Life Science revenues were up slightly in the quarter to $16.8 million as 8% growth in the immuno-related products offset a 12% decline in Molecular reagent products. This is essentially the reverse of the product mix that occurred in the first quarter and highlights the quarter-to-quarter variability we frequently experience in the second.

As cited in our April 2 press release, China continued to experience softer-than-expected customer order activity during the quarter, and while we are expecting better performance out of China in the second half, growth is likely to be more modest than we expected entering fiscal 2019.

Life Science adjusted operating income increased significantly in the quarter to $5.4 million as a result of significantly lower costs overall and the result of restructuring and organizational streamlining activities in 2018. At 32.2%, Life Science operating margin exceeded 30% for the third consecutive quarter.

Turning to Page 7. In addition to our fiscal second quarter results, this morning, we also announced our agreement to acquire the business of GenePOC Inc. While Jack will go into the strategic rationale and the benefits of the deal for Meridian in just a minute, I will summarize some of the key aspects of the transaction.

Quebec-based GenePOC is a molecular diagnostic company with about 100 employees and is in the early stage of ramping its revenue. We have agreed to a cash purchase price that could be up to $120 million with an initial payment of $50 million at closing and an earn-out structure that includes contingent future payments based on the achievement of development milestones and certain financial performance levels.

We are looking for the transaction to close within 90 days. With the transaction, we will be adding approximately $4 million to $5 million of operating expenses through remainder of this fiscal year 2019 and approximately $9 million to $10 million on a full year basis next year as we integrate GenePOC's strong R&D team and other core activities.

We currently estimate that the transaction will be $0.10 to $0.12 dilutive to our fiscal 2019 EPS for which we provided revised guidance in our press release on April 2. Our expectations are that the acquisition will start to provide a net positive contribution to our run rate molecular revenues and company EBITDA starting sometime in fiscal 2021. We plan to finance the transaction with cash on hand and through a new committed $125 million revolving credit facility.

Importantly, commensurate with our agreement to acquire GenePOC, we are also shifting our philosophy towards capital allocation. The Board of Directors has suspended the quarterly cash dividend as we intend to redirect available capital for reinvestment in the business, including development of our molecular product line. By doing this, our objective is to address the competitive pressures the Diagnostics business is currently facing and to reposition Meridian for a sustainable long-term growth.

Now, I will turn it over to Jack.

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [3]

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Thanks, Eric. As we head to Page 8, I want to take a few minutes to discuss the strong strategic fit that we saw with GenePOC with our overall strategy at Meridian. As we rolled out our strategic vision in our investor call last November, we acknowledged that molecular was a critical component for our new Meridian strategy. In recent months, we have been evaluating all options from a molecular standpoint, including internal development, strategic partnerships or potential acquisitions in order to strengthen our position in molecular.

As we did our diligence of GenePOC, it became clear that GenePOC and the revogene platform are an ideal fit for our strategy to build depth in our customer offerings for gastrointestinal and key respiratory testing. The revogene platform offers sample-to-result testing capabilities for both single analyte PCR tests as well as the capability to multiplex with up to 12 targets at one time. This state-of-the-art platform, along with its 3 FDA cleared and 4 CE mark test, make it a strong solution for our current molecular customers. This great new product, along with Meridian's breadth of other GI and respiratory products, will help us drive further towards our strategic vision.

We are also extremely excited to have the team of GenePOC join our Meridian family. This team has developed an innovative and exciting new platform and multiple assays and gained regulatory approvals for these products and built a strong operations infrastructure to support the growing molecular business. This market-ready molecular business will be ready to grow as we work to quickly convert our Meridian Alethia install base. These great new products can go to market effectively by leveraging Meridian's strong commercial infrastructure in the U.S. and European markets.

Let's move on now to Page 9. The revogene platform as well as its microfluid technology can deliver sample-to-result testing cost effectively and in a small footprint. This system and reagent technology will enable our team to protect our current molecular business and give us the capability to build and grow for years to come. The revogene's simplified sample prep and efficient workflow is best-in-class and fare well against other molecular competitors. The revogene platform also will enable our customers to provide actionable results in a timely manner with positive results available as early as 35 minutes.

Revogene's ability to multiplex with up to 12 targets per specimen will enable appropriate treatment and enhance antibiotic stewardship practices by truly providing improved outcomes for our customers.

Let's move ahead now to Page 10. The revogene platform and the tests that it has FDA and CE Marked today will enable Meridian to immediately improve our position with current customers and competitive opportunities. The revogene's platforms -- the revogene platform's capabilities match perfectly with the strategy that we developed last year. With the changing reimbursement environment, the market is moving towards smart panels, panels with 4 to 6 analytes for one sample. Our goal was to have a platform capable of cost effectively delivering these smart panels to the marketplace. The revogene platform and its microfluidic consumable enable smart panels in a cost-effective manner. This technology will also enable us to develop new assays with the ability to deliver resistance testing to further improve clinical outcomes.

A major part of our strategic vision is to become the primary partner for our customers in gastrointestinal testing. The strengthening of our molecular offerings along with the strong rapid immunoassay products portfolio we have will enable us to deliver a comprehensive dual-technology gastrointestinal solutions (inaudible) over the coming years.

The team has plans to further develop the menu on the revogene system as while still focusing on delivering the Curian system and its rapid immunoassay tests as well as the continued development of the PediaStat system to enable workstation consolidation in pediatrician offices. The key elements of our strategy are in place and we move further into the execution phase of these plans.

Let's move on now to Page 11. The fact that GenePOC had 3 FDA-cleared tests available was essential to this deal. Those tests being C. diff, Group A Strep and Group B Strep mean that we can immediately go to our long-term loyal customers and offer a new state-of-the-art molecular platform.

Over 80% of our existing Alethia molecular revenue comes from C. diff, Group A Strep and Group B Strep assays. The ability to immediately go to our customers as well as noncustomers with revogene is a great opportunity for Meridian.

After the close of the GenePOC acquisition, we see our commercial team focusing first on stabilizing and protecting our base of molecular customers. We believe we can establish a strong install base quickly with this strategy, which will enable us to drive increased competitive conversions over time as the system's reputation and menu builds. Longer term, as we drive menu expansion on this platform, we expect to return back to meaningful growth in our molecular franchise. We're excited to say the least to be adding this exciting system and technology to our portfolio, but also believe that the addition of the GenePOC team will help drive further growth -- future growth, excuse me, for Meridian over the years to come.

Hopefully, that gives you a little bit of perspective in regards to the overall strategic direction and the fit for the GenePOC acquisition.

I guess now, Dennis, we'd like to open the floor now for any questions that they may have on the call.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And your first question is from the line of Brian Weinstein with William Blair.

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Andrew Frederick Brackmann, William Blair & Company L.L.C., Research Division - Associate [2]

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This is actually Andrew Brackmann on for Brian. Maybe we could first start on the longer-term growth that you guys just sort of outlined, maybe be a little bit more specific on what this does for your longer-term plan? And what's sort of assumed in your model with respect to the current business, the cannibalization expectations there on the current platform?

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Eric S. Rasmussen, Meridian Bioscience, Inc. - Executive VP & CFO [3]

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Yes. I mean, I think, obviously, we're going to be managing for cannibalization over the near term in sort of converting our existing base and so that's going to be -- as we're going to be ramping up sales of a new platform, while we're -- and managing that conversion and frankly, doing our best to sustain Alethia in certain product areas that are still good product areas for us.

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [4]

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Yes. Let me add a couple of comments as well to Eric's comments. First of all, we -- I think, we generally see that the first 12 to 18 months, as we bring GenePOC into the family, really is going to be about first stabilizing the business. So we do anticipate, as Eric alluded to a very higher -- a higher percentage of our placements coming from conversions of existing customers. Clearly, we'll also work to identify competitive opportunities, but we do know that with the state-of-art Alethia business and Group A Strep, C. diff and Group B Strep that it is critical that we go out there.

The product that we are acquiring is a state-of-the-art simple sample-to-result type of instrument and so we believe that we can offer significant advantages to our current customers. And then obviously over time, we will work to expand that menu. So I think you can anticipate, Andrew, that we'll look to more -- we have a declining molecular business this year, there's still some of that, that has to bleed out. We have to stabilize that. We look at fiscal '20 being still some declines and stabilization on that overall molecular side and returning more to growth as you head into fiscal '21. And ultimately, we think that is consistent also with the overall Diagnostic business in that same period of time.

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Andrew Frederick Brackmann, William Blair & Company L.L.C., Research Division - Associate [5]

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Got it. That's helpful. And then maybe on the contingent consideration that I think you said there's some sort of development lines in place for that earn-out. Could you be a little bit more specific on what those are in terms of the menu and then on the gross margin goals?

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Eric S. Rasmussen, Meridian Bioscience, Inc. - Executive VP & CFO [6]

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Yes. I was -- in both cases, I think we're going to be careful about what specifically we say. In terms of the menu, I'd just say they are panel offerings and they're very -- and I think they're very much in line with our strategy for -- that we've laid out and we've sort of reinforced here today. So that would be -- that's sort of the -- they are aligned in those things and then with the -- in terms of the gross margin, it's really a function of making sure that the margins are frankly at a level that are -- that we're not in the market situation where the gross margins were -- are sort of below market profitability.

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Andrew Frederick Brackmann, William Blair & Company L.L.C., Research Division - Associate [7]

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Okay. And then last one for me, the increase in R&D -- or operating expenses, I'm assuming that's all sort of into R&D but maybe you could be a little bit more specific on what exactly those costs are going to? Are you adding more scientists? Is it going all towards sort of menu buildout? Maybe just a little bit more detail there?

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [8]

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So I'll start, and Eric, you can wrap it on me. So we did talk to the overall increase in expense that we anticipate with the GenePOC acquisition. This will clearly move us, Andrew, into a much stronger investment period for the overall business. So we do anticipate increased R&D investments from this. We have a strong R&D team up in Québec that will be coming across obviously and joining Meridian. So there will be an increased investment there. At the same time, there are also some other operations, expenses and other expenses. This was a full functioning business that was getting up and getting started and many of those elements will retain as we go forward.

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Eric S. Rasmussen, Meridian Bioscience, Inc. - Executive VP & CFO [9]

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So we're getting that the largest portion of the expenses that will be that GenePOC has is in the R&D and is in the development area, and we'll be taking good chunk of those, most of those on. So that's -- that will be the biggest addition and the biggest factor in adding new operating expenses to the Meridian's results.

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [10]

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And the last comment I would make, Andrew, is as we've talked before, the need to invest in the future of this business. We are going to be increasing that R&D percent of sales dramatically. It'll be significantly into the double digits versus the 8%, 9% type of range that Meridian had historically back. So this -- we are buying an exciting capability and technology and a great company, but we're going to continue on with increased investment as well going forward from an R&D perspective.

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Operator [11]

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Your next question is from the line of Bill Quirk with Piper Jaffray.

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William Robert Quirk, Piper Jaffray Companies, Research Division - MD and Senior Research Analyst [12]

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I'd also like to add my congratulations with respect to GenePOC transaction, pretty neat and we've had the chance to kick the tires on it on more than one occasion. Question on that is the GenePOC team had a fairly aggressive menu buildout strategy, including some of the panels that you highlighted in presentation. Should we assume that the overall priorities for that menu buildout remain the same? Are you contemplating any shifts in one direction or another? Just some additional color there would be great.

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [13]

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So as you know, the GenePOC team was aggressively driving to build the platform as well as the testing capabilities on that platform. We will be adjusting a bit of the focus for those tests as we go forward. There were certain elements of that, that were very aligned with the way GenePOC had planned and the way that our strategy was set up. However, there are some other areas that there'll be adjustment. I would say in the near future, we'll come out with a more detailed plan in regards to the overall R&D go-forward. But the early tests, as we said, really do tie more to the gastrointestinal and the respiratory areas. Those are the first things that both us and GenePOC were aligned on as we go forward.

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William Robert Quirk, Piper Jaffray Companies, Research Division - MD and Senior Research Analyst [14]

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Understood. And then just thinking about -- and you alluded to in your comments about the reimbursement environment. Obviously, with the move that Palmetto made to restrict overall payments, many of us had assumed that private payers would follow suit -- that actually doesn't appear to be happening. And in fact, there appears to be even some moves underway at National Medicare to change some of the reimbursement elements. So I'm just curious, guys, philosophically, it sounds like you're kind of building this to assume low reimbursement. Obviously, if that doesn't happen, I suppose, there's some potential upside -- longer-term upside opportunities for the GenePOC franchise.

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [15]

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So I would say -- so a couple of thoughts on that, Bill. First for all, agree that the reimbursement environment is still not completely clear yet. There was the Palmetto changes and it starts moving with private payers, whether that occurs or not, I certainly can't speak to that. I would also say that outside of the payer environment, we firmly believe before we were even looking at GenePOC that the smart panels, that running large huge panels for every person that walks through the door really is not the appropriate medical approach. There's certainly certain patients that you should do these broad panels on and we fully support that. However, there was being broad use of those panels for kind of everybody walking through the door, and we fundamentally believe that, in health care part of our responsibility is the appropriate type of testing.

So we do believe GenePOC with the capability on the revogene system with up to 12 analytes will enable us the ability to do the appropriate level of testing, certainly for gastro, for respiratory and other panels. But we will develop a menu of single analyte and multiplexing tests really designed to support the strategy we have to be strong in gastrointestinal, respiratory in a primary fashion. That's a first place that we're going to focus.

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William Robert Quirk, Piper Jaffray Companies, Research Division - MD and Senior Research Analyst [16]

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Okay. Got it. And then just last one for me is, how should we think about the, I guess, capital deployment priorities going forward? I mean you obviously are removing the dividend, wanted to refocus both internally as well as M&A. Should we anticipate that Meridian will continue to look at additional deals once you obviously get GenePOC integrated and fully funded and such?

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Eric S. Rasmussen, Meridian Bioscience, Inc. - Executive VP & CFO [17]

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Yes. I mean, I think we stated in our strategy that we want to be -- we want to make acquisitions a regular part of our -- a more regular part of our strategy than they had been in the past. Obviously, this is a big one for us and it's going to take some time and effort and resources to fully integrate and absorb. But yes, I think that is certainly part of the plan, and also making sure that we have a very solid balance sheet and we're in a position and where we -- our capital structure is in a good position as well. So I mean we're going to be looking for growth and being responsible with our balance sheet.

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [18]

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So let me just add a couple of comments to that, too. As Eric mentioned, we had talked about changing our capital deployment strategy. I think what Eric and I have discussed and we're committed to is really investing in this business to build a stronger Meridian over time. And clearly, this acquisition was a significant move in that direction, but at the same time, we also know that we're going to need to invest and we're going to increase investment in R&D and things of that nature, too. So I think you're going to see a different Meridian than you had historically with higher percents going into research and development and then obviously working to have an R&D and new product development team that can continually bring out new products. So we're actively working on the organization as well to build an organization that can regularly deliver on those fronts. That's work in progress and so we're actively working to that. But this change to the dividend policy was not something we took lightly, but we do believe that it's in the best interest to help us build a stronger Meridian for many years to come.

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Operator [19]

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Your next question is from the line of Catherine Schulte with Baird.

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Catherine Walden Ramsey Schulte, Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst [20]

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How should we think about pricing of revogene versus Alethia? If you were to convert your current customer base over, what would the net revenue impact be there?

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [21]

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I don't know that we've fully worked our way through that. We've got some work to do to get to that. But I think the best way to look at it would be is that we have a nice offering here, but we will look to have a competitive product in the marketplace from a -- what it offers our customers but also from a pricing standpoint. We're not going to go into -- just try to go become a low-cost provider, we're going to make sure that we are competitive into the marketplace. So I don't know that we're fully there yet, Catherine, we have some work to do on that front.

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Catherine Walden Ramsey Schulte, Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst [22]

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Okay. And then GenePOC lost $7 million in revenue in 2018. Any color on what they are expecting to do in 2019? And any color on the earn-out numbers around revenue?

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [23]

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I'll start a little bit, but -- so GenePOC, as an organization, did have a -- had a commercial team. As you know, when you come into the molecular space, they originally had 1 or 2 assays. They've built this up, now they've added the third and the fourth CE-Marked assay. So they were working to build the menu to enable them to effectively compete. But it's also challenging when you come into a new marketplace. So part of the reason that we felt that this made such good sense for both GenePOC and for Meridian was that they've built a great product and an exciting product that can really go a long way. But it's also hard sometimes to get the momentum and the math that you need to kind of get the ball rolling.

So we don't anticipate significant volume coming from GenePOC as an organization. They had $1 million last year, we don't anticipate it being a dramatic increase, but we do believe as we go out and work to convert some of our install base as well as then trying to sell incremental systems that we can start to build more momentum for the -- from a commercial standpoint. They had built a phenomenal product and a really good set of assays that FDA approval in a short period of time. Meridian is well positioned with our commercial team that we've got as well as our install base to be able to help kind of take what they built and take it even further. And I think that's what led the 2 groups coming together.

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Catherine Walden Ramsey Schulte, Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst [24]

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Okay. And then any update on Magellan, looks like that growth slowed in the quarter, but any update around the FDA there? And how we should think about that business growing over the next 6 to 12 months?

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [25]

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I don't think that there's any additional information from what we announced in early April in regards to -- from an FDA standpoint. There's really nothing that has changed there. From a revenue standpoint, this was lower. Throughout, it was low single-digit growth where we've kind of been in the mid-single-digit growth before. We do anticipate that this business is still -- will continue to grow and are working hard. Our team has one of the initiatives that we have not seen the full lift from yet is our sales team has been focused on not just going to individual pediatrician offices with distributors that go there like the McKessons and the Scheins of the world, but also then to try to work with the large IDNs that own many of these physician offices. And that we're starting to increase funnels in these larger IDNs, where they look at all of the pediatricians in their system and determine should they have lead-testing protocols that are consistent with all of their pediatricians. So we're working through that and that's a work in progress that we believe over time can help us to accelerate growth on the lead care products as we go forward. But we haven't seen the full lift of that yet in the first half of the year.

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Operator [26]

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Your next question is from the line of Mark Massaro with Canaccord.

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Mark Anthony Massaro, Canaccord Genuity Limited, Research Division - Senior Analyst [27]

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Congrats on the deal, nice to see some progress on the M&A front. So I guess obviously just looking at the purchase price, it's probably way too short-term oriented at 50x revenue. Building off of Catherine's question, they did less than $1 million in revenue in '18. I think I heard you say, we shouldn't expect a dramatic increase near term and then you indicated that revenues will build in -- likely in fiscal '21. Can you just provide any more clarity around that as we think about building out our models? We're just looking for some type of directional or any type of quantitative placeholder.

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Eric S. Rasmussen, Meridian Bioscience, Inc. - Executive VP & CFO [28]

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I mean, I think we -- frankly, the way we're looking at it is sort of a combined molecular business between our product and GenePOC. So we're not looking at them as individual. So obviously, we will be managing them, but we're looking at the -- sort of the overall -- the molecular business on a combined basis. And so I mean, I think that's when we look at -- when we looked at sort of how to value and how to think about this, it was really the potential of converting a lot of our existing customers and our existing base of business to a new state-of-the-art platform that is competitive and will be competitive for the foreseeable future. So I mean, I think that's kind of how we're looking at that -- the pressure in our current molecular products and offsetting as much of that as possible with growth under the GenePOC platform. And as -- I think as we indicated, that's going to -- we hope that and we hope that as we get into fiscal 2021, that will start seeing some positive contributions from where we are from a revenue standpoint today.

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [29]

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So Mark, let me add just a little bit of color to that, too. So if you look at the first 3 tests that are FDA-cleared, Group A, Group B and C. diff. Again, those are the 3 primary tests that make up a majority of our revenues on Alethia. And so obviously that conversion is important. Having been in the Diagnostic space for many years, a lot of times customers don't want to go with the only one in the state in some of the newer products. So we do believe that it's critical to build an install base, get the first couple of hundred placements kind of out there into the field, show people that it's working well and that the people down the street have the system and that it is easy to operate and works very well for their patients. So that's why we do believe this conversion will occur.

Now the one test that GenePOC that's CE Marked and that the working towards getting FDA approval is carbapenemase. And so that will be a new test for us and GenePOC, if you will, as that comes together. And so that remains to be seen that opportunity, but clearly, that's a product that there are not too many of those out in the market. It's a differentiated product. So as I said, as we had modeled it before, we also are cognizant of look at the molecular results we had in the quarter. We had a significant decline. First thing that we have to do is we have to stop customers that couldn't hold on anymore and convert them over. And so that's really going to be the first mission here. So we envision end of '19 and in early '20, going to those customers protecting them. You'll see some stabilization, but you still have some bleed out for people that left before we've done this deal. So that's why we hear panel modeling's still a decline and stabilization into fiscal '20 and then we start to see growth again in fiscal '21 as we've stabilized the base and then as we work towards starting to have new assays in addition to this coming out on the platform. We'll work to provide more color over time, but we're still in the early days on some of that here.

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Mark Anthony Massaro, Canaccord Genuity Limited, Research Division - Senior Analyst [30]

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Okay. That's helpful. And then just a clarification question. When you preannounced in April, you had lowered the full year guidance down to $0.60 to $0.65 of earnings. Just for clarification, does that include the $0.10 to $0.12 dilution of this GenePOC deal today?

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [31]

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It does not.

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Mark Anthony Massaro, Canaccord Genuity Limited, Research Division - Senior Analyst [32]

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It does not?

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [33]

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No.

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Mark Anthony Massaro, Canaccord Genuity Limited, Research Division - Senior Analyst [34]

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Okay. So we can just assume another $0.10 to $0.12 decrease relative to the $0.60 to $0.65?

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [35]

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That's correct, yes.

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Mark Anthony Massaro, Canaccord Genuity Limited, Research Division - Senior Analyst [36]

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Okay. And then longer term, I know you talked about R&D picking up. Obviously, that would be logical, given that GenePOC is a fairly early-stage company. Do you guys have any pro forma operating margin targets? Maybe you don't have that yet, but as we think about building the model out in the next couple of years, your R&D goes up pretty significantly -- that should likely weigh on operating margins. I'm just trying to get a sense on roughly where you think that shakes out in a couple of years.

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Eric S. Rasmussen, Meridian Bioscience, Inc. - Executive VP & CFO [37]

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Yes. I mean it is kind of early days. I do think we're going to have -- we will be -- again, obviously, when you add that kind of R&D expense that's going to have -- it's going to have an impact on the near-term margins. So it'll -- I think we haven't really -- I think in terms of the overall contribution of profits, I think you said in EBITDA, we're looking for it'd be sort of a positive EBITDA contribution from where we are today, including all those additional expenses of R&D into fiscal 2021. So I mean that gives you some kind of sense of sort of relayering these additional expenses and then when we -- what kind of margins we'd be thinking about looking at, at that point.

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Mark Anthony Massaro, Canaccord Genuity Limited, Research Division - Senior Analyst [38]

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Okay. And then as we think about building mini panels, I would agree that this is where the market is heading and sort of already has been heading there for some time whether it's large panel or smaller panels. But looking at GenePOC's website, for instance, you have STD panels, GI, HAI, respiratory. Can you give us a sense on where the early development will likely be in terms of converting the C. diff, Group A into panels? Can you give us a sense of the roadmap as to what the initial focus will be? And then maybe what the longer-term focus might look like?

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [39]

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So I think you'll see an initial focus that really does go to panels related to gastro and to respiratory. Those will be some of the earlier things that you're going to see. Again, so it will tie directly into the overall strategy that we had. So the beauty of this technology is that it does have that capability up to 12-plexing is a pretty significant -- gives a good flexibility to build these panels out appropriately for the right medical use and also from a reimbursement standpoint for our customers. So as we said, it will really be respiratory and gastro. Gastro and respiratory in that order, I would say, are the first couple of things that you'll see.

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Operator [40]

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And your next first question is from the line of Brian Weinstein with William Blair.

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Brian David Weinstein, William Blair & Company L.L.C., Research Division - Partner & Healthcare Analyst [41]

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Just one quick follow-up for me maybe on the competitive environment. As you guys were analyzing the deal, maybe provide a little bit more detail on how you thought this played into the larger scheme here? I think as Mark just said, there is a -- some competitors out there going into this kind of area of 12 analytes on the multiplex side. So maybe just some detail there?

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [42]

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So I'll start, and Eric, you can wrap around me. Again, our strategy that we have kind of been communicating over last 6 to 9 months really was around -- we're not trying to try to go head-to-head and trying to have menu comparisons against the largest diagnostic companies, the Walmarts of diagnostics. What we really want to do is be more of a boutique diagnostic firm, if you will, that's really focused and provides expertise in a couple of areas. The areas that we felt that we have a good position going in that we can provide even a stronger position going forward were the gastrointestinal and the pediatric point of care with our lead care product offering.

So from a strategic standpoint, we believe that there's a significant advantage for us in gastrointestinal because IDNs or integrated health systems that are out there are looking to -- they have a variety of different customer settings where people show up to the health system. They may come in to the 500-bed main hospital, they could come to the 50-bed hospital or to the urgent care facility that's connected to the health system. That difference of where people show up means that they have different testing needs. And having the capability of having deep broad menus in gastrointestinal testing with both molecular tests available and immuno -- rapid immuno tests will mean that our IDNs can offer comprehensive solutions to their customers in the gastrointestinal testing area.

So we believe with the strong position that Meridian has had in that area, the strong rapid immunoassay in our Curian product, which will help us to be even further by connecting in with the LAF systems with a small Curian platform as well. That along with an effective molecular strategy, which is what GenePOC really does for us can improve our overall position. And so we do believe that we can coexist with some of those largest companies in providing expertise in gastrointestinal testing. And then of course, you do need to provide respiratory testing for tests like flu and other types of panels that are pretty common.

The second piece of that, again, was the pediatric point of care. Point-of-care testing is a crowded market. However, in the pediatric point-of-care area, it's rather limited. And the lead care has a very strong position with over 7,000 pediatrician offices that are using lead care as part of their practice. We believe that there's an opportunity there with our next generation of where we're going there to bring a system that has lead care testing capabilities as well as other tests that are commonly requested in the pediatrician office. So really what we're looking for, Andrew, is to become that primary partner that coexists with some of these large diagnostic companies that helps these health systems or IDNs from a gastrointestinal perspective and a pediatric point-of-care perspective.

The GenePOC acquisition is a strong fit into that strategy because of the ability to have a cost-effective, small-footprint, state-of-the-art molecular platform that can multiplex. That will enable us to be able to put those molecular systems out at the small facilities. Many of the molecular competitors that we have would have a hard time placing molecular systems at the smaller sites because of the cost effectiveness of those going into those locations. So it really comes down to having an effective molecular solution within our GI strategy and that's what the revogene platform did for us. And that's why we are so interested in GenePOC from an acquisitive standpoint.

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Eric S. Rasmussen, Meridian Bioscience, Inc. - Executive VP & CFO [43]

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And Andrew, I would just add that, that competitive environment did play into sort of our evaluation of buy versus build in terms of a next-phase platform and it was really, are you -- can you afford to take more time, can you spend $30 million -- 3 years and hope that you can find that to divide -- build that platform yourself and then have an offering, a menu available on that platform. And we felt that part of that competitive environment and part of the -- that was part of our -- that went into our thinking and this was the right approach.

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Operator [44]

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And at this time, there are no further questions. Do you have any closing comments?

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John P. Kenny, Meridian Bioscience, Inc. - CEO, Executive VP of Diagnostics Business Unit & Director [45]

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No. We appreciate you joining the call. I apologize for the challenges with getting some of these press releases out and we will work to make sure that they get out to the market here as quickly as we can. Thank you very much.

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Operator [46]

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Ladies and gentlemen, thank you for joining today's call. You may now disconnect.