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Biomerieux SA
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Good day, and welcome to the bioMérieux Q1 2018 Business Review Conference Call. [Operator Instructions] Today's conference is being recorded.At this time, I would like to turn the conference over to Sylvain Morgeau. Please go ahead, sir.
Thank you very much. Good day, everyone. Thank you for joining us to review bioMérieux's performance for this first fiscal quarter of 2018. Today, I'm on the line with Mr. Alexandre Mérieux, Chairman and CEO, as well as Mr. Guillaume Bouhours, who joined as the Chief Financial Officer since March.Alexandre will start this call by a short introduction to give you its main takeaway messages about the quarter. And then most of the call will be dedicated to the Q&A session.Before I hand the call over to managements, please note that this conference call will include forward-looking statements. I would like to remind you of the usual disclaimer saying that forward-looking statements are based entirely or partially on assessments or judgments that may change or be modified due to uncertainties and risks related to the company environments, and notably those that are described in the 2017 registration documents, including but not limited to economic condition, financial exposure to currency exchange fluctuations, change in government policies or regulation, third-party reimbursement policies, timing of the onset, length and severity of flu season and competition. And accordingly, we cannot give any assurance as to whether we will achieve these objectives.BioMérieux issued its press release related to the Q1 2018 business review this morning at 7:00 a.m. French Time. If you have not received our communication or if you would like to be added to the company's distribution list, please feel free to contact me.I also remind you that today's call is being recorded and that a replay will be available on the website, www.biomerieux-finance.com.And with this, now I will hand the call over to Alexandre Mérieux.
Thank you, Sylvain. Good morning and good afternoon to all of you. I would like to start the call by highlighting the good performance of bioMérieux in the first quarter as we reported an organic growth of 12.5%. On reported basis in euros, sales growth reached 3.4% impacted by about 900 basis points of negative ForEx impact -- effects. On the -- as expected, the U.S. dollar accounted for most of the impacts.Before leaving time to more interaction with you through the Q&A, I would like to cover 3 main topics relevant with this first quarter and relevant for the future of the company. First one being molecular biology and BioFire; second being Asia-Pacific; and the third being about immunoassays.So let's start with molecular biology. So the strong flu season we have experienced this winter has, obviously, driven higher demand for respiratory panels and we have been able to serve existing and new customers during this period. And this performance is related to the numbers as the BioFire sales reached EUR 130 million in the quarter, up at a fast pace of [ nearly 60% ] organic on historic basis of conversion. It is also interesting to note that the notes was obviously written by RP panels for the reason that we just discussed, but also by all the other panels of the FilmArray menu, GI, neuritis and this year they did all very well growing even faster than the RP panel. It highlights the importance of the presumably large and adapted menu to the hospital and labs that are adopting the syndromic approach.On the instrument front, the installed base continued its rapid expansion and now which is close to 600 and 700 instruments with a strong growth in the U.S.The industrial deployment of the BioFire range also continued on a hasty way and sales outside the U.S. represented 13% sales of total sales as compared to 10% at the end of last year -- end of Q1 last year.In terms of innovation and pipeline, we announced that a new Pneumonia Panel has been filed to the FDA in April in line with our plan. It is our most advanced panel to date, which carries a strong medical value with terrific targets in about an hour, with 15 targets reported with quantitative information. We believe there will be a strong interest for panel in the hospitals as most of the time doctors are unable to pinpoint a specific cause of pneumonia. Therefore, more sensitive, faster test to identify causes of pneumonia and to promote better treatment brings -- and to promote better treatment, which brings medical value.As a word of conclusion, BioFire continues to provide exciting route perspective for the group. And we follow our path to make BioFire the industry leader of molecular syndromic testing.As a second topic, let us move now to Asia-Pacific as we're also very satisfied with the performance of this region after 5% growth in Q4 '17 the APAC region reported a 25% growth in Q1 and the uptake of sales was mostly driven by the strong provision of region sales from all strategic ranges in most countries, except Japan, which was expected due to change of distribution model. All countries delivered a sound performance and in particular, China, India, Southeast Asian countries and Korea. The growth was not only strong on the immunoassay range with VIDAS high medical value markers such as PCT, all cardiac markers performing well, supported by a more moderate, but still very decent mid-teens growth on routine assays.Microbiology also reached noticeable growth during the quarter, with sales up double digit in VITEK, BacT and Culture Media. And the impact of FilmArray became visible with a strong performance such as in India driving up the molecular sales for the region. Even Asia-Pacific is characterized by a certain volatility quarter-on-quarter, we believe that this region is a strategic area for the future as it accounts for more than half of the worldwide population with still important unmet medical needs related to infectious disease.I would like to end these [ primary ] comments talking about immunoassays and more [indiscernible] about the recent acquisition of Astute Medical. This company has already impressed our team in the way they discovered, developed, registered and built scientific and medical evidence for the use of novel biomarkers for the risk assessment of acute kidney injury, AKI. Today, about half of ICU patients develop AKI, which apart from an increased risk of mortality, [ increase of sort of total patient to us ]. The available solutions come too late to help prevent kidney damages. Hence, the need of the predictive diagnostic tests for all these patients.The NEPHROCHECK test developed by Astute is a strategic move for bioMérieux. It perfectly fits bioMérieux's objective to differentiate VIDAS through proprietary markers, also our ambition to provide high medical value contents to our customers. So we're very enthusiastic about this future business opportunity associated with these markers.So as a conclusion, bioMérieux was again able to deliver a very solid commercial performance this quarter. And in parallel was able to invest for the future of the company with the future launch of the Pneumonia Panel and also with the acquisition of Astute for the benefit of our patients and of the immunoassay franchise.[indiscernible] so to resume, now I propose we move on to the Q&A session.
[Operator Instructions] Our first question is from Peter Welford from Jefferies.
Apologies. I joined a little bit late. I wonder if you could tell us maybe you may have said this, what the number of placements were of the FilmArray instruments in both the U.S. and ex-U.S. regions during the quarter. And so what the year -- the 31st of March end number of FilmArray instrument is? I wondered also if you could possibly give us the contribution you think from the flu season. Because, obviously, it was a more severe flu season, can you sort of perhaps give us a magnitude of how much you think the incremental benefit was, if possible? I appreciate you may not be willing to do that. Then going on to Bio Defense, could you possibly disclose what the sales of the Bio Defense business were in the quarter? And then could you just comment a bit further on VIDAS? The tone of the commentary in the press release suggests that the trend there is there is more slowing for the high medical value tests that you give there. I appreciate the headwinds. Obviously, you're facing some competition in the U.S. Could you provide any more insight into the dynamics you're seeing in that business line?
Okay. So we will try to answer to the 4 questions. So the first one -- the first one [ you referred today is now ] the FilmArray instruments is close to 600 and 700 instruments, which is a nice [ uptake ] compared to the last figures we communicated in end of Q4. We also said that now we have -- in Q1, we have 13% of the sales, which are done outside of the U.S., which is higher than what we had at Q1 at the same time last year. Clearly, the flu season helped, we believe, in the growth of BioFire. Difficult to quantify really the impact as it's -- as we're on a growing phase with FilmArray. But as I mentioned also during my call that RP clearly grew, but it's true also that the other panels grew quite well also in some time at a faster pace than RP. So yes, I believe like our competitors, we benefited. So it [indiscernible] from the -- in terms of flu season. Difficult to quantify exactly, but it's a good start. It's a good Q1 for us. The sales of BioFire Defense on the first quarter were at USD 5 million. Your other question was around PCT, I guess, in the U.S., but let's say, if we grew immunoassay on the first quarter, on a worldwide basis, we grew quite well. The immunoassay franchise on throughout Asia-Pacific was a key contributor of the growth. On the U.S., as I've mentioned, yes, we are facing tougher -- tougher competition with an impact on the ASP, while the volume of test of PCT is still growing for us in the U.S.
[Operator Instructions] We have another question from [indiscernible] from RBC Capital Markets.
Apologies. I'm joining the call a bit late. I was just late for the call. I was just wondering, can you -- I have a number of questions. Just wondering, can you brief me on the clinical trial data for the Pneumonia Panel that I thought they released this morning on the specificity and the sensitivity that you saw in the clinical trial? And also, how many subs do you see [ as ]? [ Does there -- do the ] '18 QVAR cover? And what is the speed to answer of this panel, like from the [indiscernible] sample to answer? Yes, it would be helpful if you could give me a bit of detail here?
Yes. I won't deep dive too much into the guarantee of the test, but we announced today that we filed this panel. It's not FDA approved yet. It will take some time to get the FDA review. Although we mentioned, it's a -- we believe that it's a high medical value panel because, as I mentioned, I think most of the time, it's difficult for the doctors to pinpoint the right treatment linked to the pneumonia. So the benefit we have with this test is the fact that it's quite compressive and it's a 33 target, plan to result using the 1-hour range and the beauty of it is that also it's working on different type of samples such as BAL, Sputum and I never forget -- I was forgetting this was, endotracheal aspirate. There will be more specific information to come on future, I would say, communication. Yes, as you know, the ECCMID Congress, which is the European Congress for infectious disease in the next few days and unveil some data around the Pneumonia Panel [indiscernible] coming days.
Okay, okay. okay. Just one more question, if I may. Is the Pneumonia Panel -- do you have CE mark already?
No, not yet. We will -- we are preparing this one also.
Okay, great. Can I ask one more follow-up question, sorry, sorry. I understand that the -- obviously, you include bacteria resistance markers and viruses as well. Normally people say that the majority of allergy infections are caused by like bacteria and fungus. Can you provide me a little bit of information on why you included the viruses as well?
Because we asserted -- because we know that it has a medical relevance. But what I can say -- then, I guess, just to come back, I think there will be more communication -- there will be scientific communication around this maybe in a different setting than this call. So...
[Operator Instructions] Our next question is from Peter Welford from Jefferies.
Sorry, just one quick follow-up. On the Astute Medical deal, I think you mentioned in the press release that there could be a 60 bps impact on the contributed EBIT target for the year. Did just -- is that a 60 basis point impact potential on the margin? Or is that a potential 60 bps impact on the absolute number? And on that commentary, I guess, why haven't you changed your outlook for the full year based on that deal. Is it because it's yet to close or do you think that there are other parts of the business that could somewhat mitigate the impact of the Astute Medical acquisition?
So, yes, we did mention 60 basis points impact for the year from this acquisition. As you understand, this acquisition is still in, let's say, development mode, especially for the automated version of the NEPHROCHECK test. That's why they are still significant, let's say, cost to there in the development phase. The 60 bps, just to clarify, is an impact on the global group [indiscernible] margin, contributive operating margin, I mean. And this is compared to our earlier guidance, which was EUR 325 million to EUR 345 million of contributive EBIT. So I'm not sure it was fully understood, but we did actually change with this announcement our guidance.
[Operator Instructions] There are no questions in the queue at the moment. We do have another question from Hugo Solvet from Bryan Garnier.
On the strong contribution from Asia-Pacific and what seems to be an increased digitization rate here, can you give indication on the trend that you expect for the remaining of the year? And if any other impact on -- impact at Q1 sales to the point of offsetting a weaker Japan actually?
It was a strong Q1, that's for sure. I believe that the performance of Asia-Pacific in '18 will be, I would say, maybe in the same range that what we did last year, so it will be -- we keep moving the momentum of the company in this region. We are favored by, I would say, our investment and the fact also that I mentioned, there are still a lot of unmet clinical needs there, where bioMérieux is well positioned to tackle and take position.
Japan?
Hugo, you had a question -- you had a specific question on Japan?
Not specifically, just putting it back in the context of Asia-Pacific, but if you just follow up on the answer you just gave? If we're supposed to end 2018 at around the same growth rate of last year, it means that Q1 has definitely been impacted by strong ordering, which country might have driven this increase than in Q1? Or which specific instruments?
China was great in this Q1. But then again, it's 1 quarter. So it's -- there was a bit of selectivity, we say, in the region. But all in all, the trend in Asia-Pacific is quite good. I mean, in line with our expectation and in line with the adjustment we have done in the region.
Our next question is from Christophe Ganet from ODDO.
Actually, I have 4 of them. Maybe I'd like to hear you about Brazil. Do you think that we shall expect an impact of the change of your software on Q2? Or is it fully temporary and completely past after this first quarter? The second question is related to Europe. Do you see in the reasons that does explain the trend on the first quarter? The reason for changes or that we shall expect acceleration in Europe in the coming quarters? Then the third question would be on the proportion now of the machines, so equipments and consumables on BioFire. Can we -- can you provide us an update on this proportion figures? And the last one is related to Japan. Here again, can you provide maybe a little update on when shall we expect takeoff on your sales now since that you've reshuffled your local organization, let's say?
Okay. So the first question is on Brazil. Brazil -- the impact this month for this quarter is linked to the change of ERP system. We believe this is more linked to, I would say, type of -- interesting type of issues and not maturing, let's say, change of dynamic for bioMérieux in Brazil. Even if Brazil is a complex market by itself, quite volatile. For Europe, your question, I forgot your question, I'm so sorry. Acceleration, Europe, I think, we should be -- we have our plan. FilmArray should be the strong contributor of the [ goals ] for Europe this year. As you know, also [ down in ] Africa, we've done some investment there also, which would show the growth, so too early to tell, but I think we're on track.Consumables on the FilmArray, this is, I would say, same or like the average of the company? This is evolving and the good news that we have more and more customers using more and more panels. It was in the right direction. And regarding Japan, it means that, yes, we're changing the model. We have announced at the end of the JV last summer. Now we are transitioning also to take back another service, which was still in the -- operated by our ex-partner. So we should be on track now to propose a full service and full solution to our customers.
[Operator Instructions] There are no questions at the moment.
Okay. Maybe so still no questions.
No questions.
Okay. Great.
Very good. Thank you all of you for your participation in today's call. And our next release will be in July, and so we are looking forward to seeing you in several conferences or several meetings by then. Thank you very much. Bye-bye.
That will conclude today's conference. Thank you for your participation, ladies and gentlemen. You may disconnect.