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Qiagen N.V. (QGEN)

Q4 2015 Earnings Call· Wed, Feb 3, 2016

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Transcript

Operator

Operator

I am Patrick Wright, your Chorus Call operator. Welcome and thank you for joining QIAGEN's Conference Call to discuss the results of the Fourth Quarter and Full Year 2015. At this time, all participants are in a listen-only mode. Please be advised that this call is being recorded at QIAGEN's request and will be made available on their Internet site. The presentation will be followed by a question-and-answer session. At this time, I would like to introduce your host, John Gilardi, Vice President of Corporate Communications and Investor Relations at QIAGEN. Please go ahead.

John Gilardi - Vice President, Corporate Communications and Investor Relations

Management

Thank you, Patrick. And welcome to all of you, and thank you for joining our conference call today to review the results we released last night and provide a business update and also discuss our prospective for 2016 before we get to a Q&A session. Our speakers today are Peer Schatz, the Chief Executive Officer of QIAGEN; and Roland Sackers, the Chief Financial Officer. Also joining us today on the call is Dr. Sarah Fakih who joined our IR team and has previously worked in R&D at QIAGEN. On slide two, you see the customary Safe Harbor statement explaining that the discussion and the responses to your questions on this call reflect management's views as of today, February 3, 2016. We will be making statements and providing responses to your questions that state our intentions, beliefs, expectations, predictions of the future, and these constitute forward-looking statements for the purpose of Safe Harbor provisions. These can involve risks and uncertainties that could cause actual results to differ materially from those projected. QIAGEN disclaims any intention or obligation to revise any forward-looking statements. For more information, please refer to our filings with the U.S. Securities and Exchange Commission. Also during the call, we will be referring to certain financial measures not prepared in accordance with Generally Accepted Accounting Principles, or GAAP. You can find a reconciliation of these figures to the GAAP measures in the press release and the presentation for this call. As the last point, we are planning to hold a series of events this year to give you the opportunity to learn more about QIAGEN, and we will keep you updated as we schedule them during the year. With that, I would like to now hand over to Peer. Peer M. Schatz - Chief Executive Officer & Managing Director:…

Operator

Operator

Thank you. Ladies and gentlemen, at this time we'll begin the question-and-answer session. Our first question today comes from the line of Jon Groberg of UBS. Please go ahead.

Jonathan Groberg - UBS Securities LLC

Analyst

Great. Thanks a million. Peer, can you – if you think over the last few years where HPV – U.S. HPV has been a big headwind. You've done a remarkable job in terms of keeping your margins fairly stable. And I think one of the disappointments for investors as you move into 2016 is maybe not seeing that operating leverage and earnings leverage and so forth. Can you maybe elaborate as to why we're not seeing it in 2016 and when we will see some operating leverage? Peer M. Schatz - Chief Executive Officer & Managing Director: Sure. So obviously when we looked at 2016 and planning for 2016, and we tried to take a very balanced view, also considering that we are making significant target in investments in areas that are still ramping up. We made significant increases also beyond our initial expectations in the QuantiFERON resource space. So that has become a much larger commercialization engine than we originally thought, but the growth rates are also very substantial. In addition, we are quite excited about the GeneReader franchise, which initially was targeting a smaller segment, and now with the initial feedback over the last few months can go broader. So there is a broader resource base also allocated to that, which is clearly not recognizing the average sales that we see on the rest of the business per head count, because we are still in ramp up mode there. So it's really all about – and you will see from I think the numbers going forward that the majority of these investments are in the commercial engine, where we have made significant changes. And in 2016, you are probably going to see some of these investments have a higher weight versus than probably in the second half of the year and then the years thereafter show more leverage. The goal for 2016 was to show top-line flexing from the 3% to 4% now up to the 6% guidance that we gave. And for the periods then thereafter we think that the EBIT line, the bottom line will then start accelerating as well and show that leverage from the top-line pull-through, which we think will continue also based on the longevity of these growth drivers for quite some time.

Operator

Operator

Our next question comes from the line of Tycho Peterson of JPMorgan. Please go ahead.

Tycho W. Peterson - JPMorgan Securities LLC

Analyst

Thanks. I want to ask on two things, the – just the issues that were there in 4Q, the lumpiness in the companion diagnostics business and the lower instrument revenues. Do you expect these to linger in the first part of the year, or if some of those actually come through in the first month here? And then secondly, can you give us a little more color on the underlying growth assumptions for the divisions? I'm just trying to understand where you're really modeling an acceleration I guess from our perspective things like GeneReader, while interesting, you are only launching with one assay. It's a reagent rental model. You've got some cannibalization of therascreen, so it probably doesn't move the needle that much. So can you maybe just give a little bit color of what could really drive the accelerating growth for 2016 as well? Peer M. Schatz - Chief Executive Officer & Managing Director: Well, the – I'll take the second question, Roland, if you take the first one. The second question was the – is – if you look at the trajectory of revenue growth that we had over the last few years ex the HPV headwinds, it was always fluctuating anywhere between 5% and 10% and typically somewhere between 6% and 7%. And so this is pretty much the basis that we put out now for 2016. So it's the trajectory that we've seen in the prior years, plus with the – minus the HPV headwinds. So that doesn't really imply a significant acceleration for 2016 in the guidance. It's a continuation of the current trend with now just the elimination of that headwind. On top of that there's a percentage point of MO BIO baked in there as well. So you see, I think it is…

Tycho W. Peterson - JPMorgan Securities LLC

Analyst

Thank you.

Operator

Operator

Our next question comes from the line of Bill Quirk of Piper Jaffray. Please go ahead. William R. Quirk - Piper Jaffray & Co (Broker): Great. Thanks. Good afternoon. First question actually is the two-part question, so I guess first off is, on the refugee crisis, kind of help us think a little bit about what this could do to the QuantiFERON performance I guess in 2016. And then secondly, Peer, just curious kind of how you are sizing the desktop NGS market for targeted panels? Thanks, guys. Peer M. Schatz - Chief Executive Officer & Managing Director: Sure. The QuantiFERON opportunity remains vast and the recommendations that came out from WHO and others to also expand the use of QuantiFERON, which was traditionally seen as a developed world product, now into developing countries, that was a watershed event. There was something like a religion war going on for many years; is latent TB screening better or is active TB screening better? And we clearly believe that you have to address the pool of the disease prior to it becoming something that will further contribute to the spreading of the disease, i.e. prior to becoming active. And now the first subgroups of populations, also in developing countries have been called out as segments that should be screened using latent TB tests, in particular risk groups. And that's why we're also now highlighting the HIV populations and the pregnant women segments of the market that are now targets for latent TB screening. So the developed world is still barely penetrated – it's barely double-digit penetrated as a percent of the total market. And the developing world, we are basically starting at very low points, and again, moving up into very exciting numbers and are active on many, many regional and national…

Operator

Operator

Our next question comes from the line of Scott Bardo of Berenberg. Please go ahead. Scott J. Bardo - Joh. Berenberg, Gossler & Co. KG (United Kingdom): Yeah, thanks very much for taking my questions, Peer. Actually, two quick topics. First of all, just looking into gross margin, there's been a little bit of contraction in gross margin over the last successive quarters. Obviously you mentioned the timing of the companion diagnostic revenues, which require high gross margin. But I wonder if you can just give us a little bit of an outlook on gross margin into 2016? What are some of the positive and negative considerations, both 2016 and beyond? Second question just relates to catalysts. Thank you for just giving us an outline of the things to watch. I think one thing you didn't mention was your Capital Markets Day, which I think you were highlighting at the last update for around springtime. Just wonder if you could give us a feeling for when that will be and when you are likely to set any midterm targets. Thank you. Peer M. Schatz - Chief Executive Officer & Managing Director: Excellent. So Scott, I'll ask Roland to answer the question on the gross margin and will answer the one on Capital Markets Day together with John Gilardi. So Roland, do you want to take the first one? Roland Sackers - Chief Financial Officer & Managing Director: Yeah, sure. On the gross margin side – and hi Scott, it's something what we I think said also before. For 2016, we was (45:57) expect the gross margin all-in to be probably quite flattish compared to 2015, where at the same time we believe that we have some opportunities to improve gross margin beyond 2016. And one clear driver for that is opportunity on insourcing QuantiFERON. We are probably right now halfway through. It is clearly a major product for us in the meantime and most all production steps was significantly outsourced and we are insourcing significant parts now, which has clearly also a costing impact for us. So I guess that is one area. General cost mix will be more favorable as we see that molecular typically comes with a slightly better gross margin in general than other customer classes in our portfolio. So the overall mix development, for example also including bioinformatics that's having a faster growth rate are going to help us here. And again, we all know that for the last three years we had a significant headwind on the gross margin side as well, which was again out of the HPV situation in North America that this is getting now less of an topic over the course of 2016. It's clearly also good news for us over the course (47:24) of the year as well.

John Gilardi - Vice President, Corporate Communications and Investor Relations

Management

Scott, in terms of your question about the Capital Markets Day, we were looking at a date in spring, but we feel, due to various factors, we're going to do one later in the year. Also give us a chance to give you more color about where we are with GeneReader and some other developments, but we're going to do various events on the phone and also in person for people in the U.S. and Europe during the year as well and to complement that with a chance to meet and kind of give a wrap-up. But we'll give you more information later in the year as we progress.

Operator

Operator

And our next question comes from the line of Brian Weinstein of William Blair. Please go ahead. Brian D. Weinstein - William Blair & Co. LLC: Hey, guys. Thanks for taking the question. With respect to liquid biopsy, you guys are obviously a player more on the front end. Do you guys have intentions to broaden your reach and go deeper in liquid biopsy? And if so, is that an area of focus for M&A for you for this year? And maybe you can touch on kind of this broader areas of focus for M&A as well? Thanks. Peer M. Schatz - Chief Executive Officer & Managing Director: Sure. So, in liquid biopsy, you're correct to point out that we have a strong franchise in the area of sample technologies and we're expanding that and you'll see a lot over 2016 as well in that area. The presence that we have is – I think there's no company having as many touch points into liquid biopsy as we do. Almost all of these liquid biopsy companies are using our sample technologies to be able to target those rare circulating analytes or rarely present analytes. At the same time, we also pioneered the first companion diagnostic with a liquid biopsy, creating a Sample to Insight solution with the CE marking of the EGFR assay for use with IRESSA. In monitoring, you typically want to have fast results and inexpensive results and go into higher iterations. So this has proven actually to be a very interesting addition to our portfolio, which is very well received. In addition, we also announced that GeneReader will receive liquid biopsy capabilities, making a Sample to Insight solution also available for next-generation sequencing for our panel work. So it is an integral part of our portfolio, right…

Operator

Operator

Our next question comes from the line of Derik de Bruin of Bank of America Merrill Lynch. Please go ahead.

Derik de Bruin - Bank of America Merrill Lynch

Analyst

Hi. Good morning. Peer M. Schatz - Chief Executive Officer & Managing Director: Good morning.

Derik de Bruin - Bank of America Merrill Lynch

Analyst

Two questions. So you know there – could you just give us a little bit in terms of the size of some of the growth driver markets – your (51:48) percentage of revenues you got? For example, could you size us the QuantiFERON exposure, how big of a percentage of sales is that? How big your companion diagnostics? And how big the NGS is? I'm just trying to get a better sense for modeling purposes to get a better sense of what the growth opportunities are. Peer M. Schatz - Chief Executive Officer & Managing Director: Sure. Well, as Roland detailed in the call, the QuantiFERON revenue base 2015 was about $115 million. We have a – showed a 20% growth rate last year and are stepping up that growth rate in 2016. The market opportunity, as we detailed many times, we believe it is probably around $1 billion under the current recommendations. And this is just based on the existing and to-date performed skin tests and market opportunities that we think are – represent also opportunities that with a – that are feasible to convert to QuantiFERON. So it's a vast opportunity, but these markets don't snowball. They – as we've seen in other markets, they kind of convert one segment at a time. The other one is the companion diagnostic franchise, as we've detailed also previously is about $100 million in size and is also for us a growth engine that is expanding, as you see from the number of new partnerships and also the announcements that we did this year. And this will further expand with the addition of next-generation sequencing, which by itself is a growth driver that we detailed could – just is alone (53:33) – we today, even prior to the launch of GeneReader, we said a few times that we're north of $75 million in sales in 2015 and that portfolio that relates to next-generation sequences – and we're not entering into a market, we're there. We're really one of the larger players already in this market with a portfolio present in the target segment that we have, and we're now adding on to that with a complete Sample to Insight solution. So these growth opportunities are vast, as you see. Just those alone are just the tips of the iceberg. And like, most of you have written reports on all of these showing massive numbers that we're trying to be conservative on and take this into a very incremental mode. But the platform has been built, and we are now in execution mode to be able to address this.

Operator

Operator

Our next question comes from the line of Jeff Elliott of Robert W. Baird. Please go ahead. Jeff T. Elliott - Robert W. Baird & Co., Inc. (Broker): Yeah. A question for Roland quick is, on the free cash flow, could you give a 2016 guidance number? And then how should we think about the cash-on-cash returns on some of the investments you're making? Really in light of where the stock's headed, you described it as being undervalued. How do you think about the tradeoff there between investments and buybacks? Thanks. Roland Sackers - Chief Financial Officer & Managing Director: As you have seen, 2015, I think that demonstrated quite nicely our ability to grow, again, cash even much faster than net income. And again, if you see the underlying net revenue growth we had in 2015, especially with currency headwinds we had, to be able to increase cash flow by 9% to roughly $220 million free cash flow, I think, is showing our commitment to what we said I think now three years ago on our Analyst Day where we said we want to double operational cash flow over a period of, at that time, four years to five years. And I think we feel quite comfortable on that way. We do expect that also cash flow is growing faster than net income again in 2016. We clearly now also said that we growing especially in the first part of the year have larger amount of incremental investments, but at the same time we do believe that there should – that the return of these investments should come in over a reasonable time period as well. Clearly, if you set up new local offices, it takes some time to get you to a breakeven point, but nevertheless within of a 20 – 12 months to 18 months time period you are typically on a – in a reasonable scale here as well. And also the activities around QuantiFERON should be allowing us to get here some traction, because we clearly do not start here from zero. It's as Peer just said, a significant part of our business. We just see here very nice development over all of the world, allowing us to grab even a bigger market share. As we all know, the overall penetration is still very low. Again, it's probably 15% of skin tests. So also here the returns should come in quite quickly.

Operator

Operator

Our next question comes from the line of Daniel Wendorff of Commerzbank. Please go ahead.

Daniel Wendorff - Commerzbank AG

Analyst

Thanks for taking my questions and two if I may. Starting off with the EBIT margin and development, I understand what is going to happen in 2016, but maybe you can give us a sense of how we should think of the EBIT margin developing beyond 2016. So the investment programs you highlighted to us, is that something we should also consider beyond 2016? And my second question would be actually a follow-up question on the instrument side. And can you potentially tell us what percentage of instruments are not placed on a reagent rental basis? And also potentially how this compares to the industry. Thank you. Roland Sackers - Chief Financial Officer & Managing Director: Starting with the first question. Overall you will see already in the – over the course of 2016 an EBIT margin development. It's quite obvious that of course we start a little slower here into the year, but leaving the year is clearly a number which I would expect is already quite significantly higher compared to, again, to where we start into the year and probably also then, a good basis moving into 2017. So I would expect a EBIT ratio somewhere again in the high 20s, leaving 2016 end of the year. But beyond 2016 we are clearly very much committed in terms of margin improvement. So as we said before there's 50 basis points to 100 basis points margin improvement as a midterm goal on a yearly basis. It's still something where, again we are working towards and what we have seen here is a nice opportunity to invest into areas where we either believe that we are underrepresented in terms of market share compared to the global share QIAGEN has, therefore there's regional expansion. Or we see opportunities like QuantiFERON, like…

Operator

Operator

Our next question comes from the line of Steve Beuchaw of Morgan Stanley. Please go ahead. Steve C. Beuchaw - Morgan Stanley & Co. LLC: Hi. Good morning or good afternoon and thanks for taking the questions. I have a two-parter related to the organic growth outlook for 2016. So point number one, if I look at the Academic and Pharmaceutical segments over the last two or three quarters, the trends there have certainly gotten a little bit better as the underlying markets are a little bit better. So are you assuming that those growth trends hold up? And then Peer, as I think back to the comment that you made about the ex HPV growth in recent quarters, it's certainly a very fair comment that the growth has been stronger. All that said, it would seem like if we're assuming that Academic and Pharma growth holds up at a level that's more similar to what we've seen over the last two or three quarters, you're giving yourself more cushion on Molecular Diagnostics and the growth there; is that correct? And if so, is that more about just taking a more conservative approach on companion diagnostics, or is there some other driver there? Thanks. Peer M. Schatz - Chief Executive Officer & Managing Director: Thanks. Yeah, good comment on the academic growth. I think everybody is feeling that there is a tailwind – at least expected tailwind for 2016 now in Academia and we saw – we indeed saw a lot of improvement over the second half of the year. We've significantly restructured and reorganized that business over the last three years as well as we detailed many times and there is a very exciting also innovation pipeline that we are taking forward. And as we all know that this…

Operator

Operator

Our next question comes from the line of Gunnar Romer of Deutsche Bank. Please go ahead.

Gunnar Romer - Deutsche Bank AG

Analyst

Good afternoon, everyone. Thanks for taking my question. And the first one would be with regards – can you help us understand a little bit better how you think about the phasing going into the second half of the year and potentially an exit rate into 2017, what should we think about ballpark wise? And then technically upon your companion diagnostic pipeline on – can you share anything about the potentially upcoming catalysts, just how should we think about that over the course of 2016? And then last one is just if you can remind us of your exposure to the British pound? Thank you. Peer M. Schatz - Chief Executive Officer & Managing Director: Okay. Number one and three, I'll ask Roland to take. I'll take number two. The Personalized Healthcare portfolio, there are indeed quite a few catalysts for 2016 as well. Unfortunately some of them are tied to drugs where we are under confidentiality, and therefore I'll have to refer to the date where we have a PDUFA or a similar announcement that would be coming out from the pharma companies also related to our diagnostic. But there's quite a bit in the portfolio that today spans all three platforms, PCR, Modaplex and next-generation sequencing. And I'd love to share this with you; it's a really exciting pipeline, but unfortunately this is something we have under CDA. Roland? Roland Sackers - Chief Financial Officer & Managing Director: Yeah. On the currency side I think you're referring to the movements we have seen over the last couple of days. And again, between the time we have given – what you have just seen just generally is of course that a couple of currencies devaluated quite largely against U.S. dollar, like the British pound to 2.3% or $12, $3;…

Operator

Operator

And our next question comes from the line of Jack Meehan of Barclays. Please go ahead.

Jack Meehan - Barclays Capital, Inc.

Analyst

Hi. Thanks for squeezing me in. I want to ask two questions, one on international HPV and then one on the companion diagnostics piece. For international HPV, I'm just curious what the expectations are for this year around growth in that business, whether it's price or volume. Any detail there would be great. And then on the companion diagnostics piece, want to focus more on the assay side what some of the trends you are seeing in the market are. I know last quarter you talked a little bit about some of the reimbursement seeing some nervousness in the market. I was wondering if you saw that dynamic change at all. Thank you. Peer M. Schatz - Chief Executive Officer & Managing Director: Sure. So first question, HPV international, we are seeing volume increases and we are seeing pretty steady prices in Europe. In Asia it's a little bit a mixed bag, but also here it's a very attractive market and we've seen very good growth in Asia and it's a sizable piece. Actually the revenue growth – the revenue portion ex U.S. is now larger than the revenue portion in U.S. and so – hence this is an important question. What we have to note in Europe is that prices were always substantially lower than they were in the United States. The average price of a diagnostic is often only 50% of what it is sold for in the U.S. Prices are much lower and much more competitive in Europe than they are in the United States. And so this has already been baked in and there hasn't been a big change as we, for instance, saw in the United States over the last three years in pricing. In companion diagnostics, there has been some stabilization and a lot of institutions are clearly eating the cost of the companion diagnostic. It is still a very weird situation right now. In the U.S., obviously with the FDA approved assays, we have a lot of tailwind and institutions that are working with payers that are fully reimbursing these. And again, the FDA approvals really help. In Europe it's very spotty. It's very different country by country and payer by payer, but it has become more established and more mature, and there's less complexity and uncertainty around these things, because people have a little bit more experience. So the nervousness has been removed and people have kind of found a way to live with it in the last couple of years and increasingly also in 2015. The big question now is on the reimbursement of the next-generation sequencing panels that is obviously important for us, and we'll see what – where this will go.

John Gilardi - Vice President, Corporate Communications and Investor Relations

Management

So with that – Roland, would you like to jump in? Roland Sackers - Chief Financial Officer & Managing Director: No. Thanks.

John Gilardi - Vice President, Corporate Communications and Investor Relations

Management

Okay.

John Gilardi - Vice President, Corporate Communications and Investor Relations

Management

With that, I'd like to end the conference call for today. If you have any questions or comments, please do not hesitate to contact Sarah and me, and we look forward to seeing you in the coming weeks at various industry events. Thank you.

Operator

Operator

Ladies and gentlemen, this concludes the conference call. Thank you for joining and have a pleasant day. Goodbye.