Q Fagron Q1 2015 Trading Update Company: Fagron Conference Title: Q1 2015 Trading Update Presenter: Ger van Jeveren Date: Thursday 9th April 2015 Operator: Good day and welcome to the conference call regarding Fagron’s Q1 2015 Trading Update. Today’s conference is being recorded. At this time I would like to turn the conference over to Mr. Van Jeveren and Mr. Peeters. Please go ahead. Ger van Jeveren: Thank you operator. Good morning everybody, this is the conference call regarding the Trading Update of the First Quarter 2015. We have a presentation shown on the Fagron.com website at investors.fagron.com. This presentation is the basis of this conference call. So when you proceed to page 1 of the presentation. We have an excellent start of the year, a total growth of 29.8% and organic growth of 16.8%, 10.5% at constant exchange rates. We achieved a very strong growth at Fagron Compounding Services, the segment with the highest margin. We have a continued focus in 2015 on robust organic growth and an active buy-and-build strategy and the construction of GMP-compliant compounding facilities. We confirm our outlook for 2015. Then we proceed to page 2 and there you see a slide where we elaborate on our unique position in the global compounding environment. What we are now experiencing is that economy of scale is really paying off. We see in Brazil competitors falling out due to the fact that they cannot purchase pharmaceutical raw materials due to the volatility of the dollar and the strong pricing of the dollar. We see that we can profit from a lot of cross-selling activities which really accelerates our innovation speed globally; and when you look at operations we see that the cost of quality is really increasing in our environment and that some competitors cannot follow that, and are approaching us for, let’s say, to buy them eventually. Page | 1 Ref 9228158 9 April 2015 Q Fagron Q1 2015 Trading Update When we go to page 3 you see our unique Fagron business model in the compounding environment. There you see that, as we have said, we are increasing our share in the Fagron Compounding Services sector from 22.4% in Q1 2014 to Q1 2015, it’s now 37.2% of total turnover. That’s a very good sign as we stated. We see that a lot of hospitals are ready for outsourcing and also that competitors want to start discussions with us about takeovers. Fagron Trademarks is 10.1% of total turnover. We hope that it will grow in the future to 15% and Fagron Compounding Essentials was 52.7% of total turnover. We think that in the near future we are going to increase Fagron Compounding Services as a % of total turnover. Then we proceed to page 4, we elaborate a little bit more on Fagron Compounding Services. We achieved a strong turnover growth of 116.5% driven also by an organic growth of 41.7%. We see an increased amount for sterile compounding, and by the way, we received the highest amount of prescriptions in sterile ever, so that’s underpinning our focus on sterile. We are compliant with the highest, most stringent quality standards such as FDA, GMP and 503B. It’s the highest margin segment where we are active in. We are now finalising the new antibiotic facility in the Netherlands which will be open in June 2015. Our new sterile state-of-the-art facility in Wichita, US will open in January 2016. Our expectations are already confirmed by the demand because a lot of the increased volume is coming from Wichita (Kansas), from our existing facility. More hospitals are ready to outsource compounding, especially in Europe, so the trends seen in the US years ago, is now coming to Europe where typically a lot of hospital pharmacies are making a lot of compounding still. Especially sterile, oncolytics and so on. They are more and more ready to outsource their compounding also due to the higher quality demands. These higher compounding or regulation demands are leading to higher costs for new building or making a a hospital pharmacy state-of-the-art. So the Boards of Directors of hospitals have to decide whether they are going to invest in or divest compounding. In Fagron Compounding Services we are actively looking into potential acquisition targets. As we stated, also competitors are approaching us for negotiations, so that’s a good sign as well. Then we go to Fagron Trademarks on page 5. Turnover growth is 8.8%, or 4.6% growth at CER. It’s driven by the global launch of Fagron Advanced Derma and especially SyrSpend which is a Page | 2 Ref 9228158 9 April 2015 Q Fagron Q1 2015 Trading Update perfect base for medicine suspensions. Growth is also driven also by the Global Fagron R&D network of 300 pharmacists and 45 researchers. The global presence of the company boosts cross-selling and innovation. We see more and more cross-selling across Fagron and we are profiting a lot from that. As a result of that, we have a strong and extensive R&D pipeline and roadmap. This pipeline and roadmap includes concepts such as psoriasis, alopecia, pain and obesity. For example big pharma is using the Fagron Trademark SyrSpend for their clinical trials underpinning the scientific value and also the scientific power of our Trademarks. Then we proceed to Fagron Compounding Essentials on page 6. We achieved a turnover growth close to 4.7%, CER 0.2%. We see there an improvement of margin due to the product portfolio optimisation, centralised purchasing power, product efficiency and allocating to lesser production locations. We are focused also on Fagron compounding innovations. As we stated for example in Brazil we see that competitors are not catching up and are not able to purchase even raw materials in China anymore due to currency effects; and also the cost of quality is increasing heavily in the compounding environment making us more powerful for our customers. We are looking also at potential acquisitions in the Fagron Compounding Essentials segment. So then we will explain the war chest. Jan is elaborating on that. Jan Peeters: Talking about acquisitions, as we mentioned earlier we are now looking actively in some acquisition targets. After the divestment of Corilus which we did at the end of March, we can state that now we have a war chest of roughly €100 million on the assumptions that of course we reach our current outlook of €500 million of sales with an EBITDA margin of 26%, that our EBITDA free cash flow conversion percentage is 50% and that we pay on average 5.5 times for these acquisitions which is our historical multiple. Of course it includes the Corilus proceeds which were realised at the end of March 2015 and after the payment and the earn-outs of past acquisitions and the payment of the dividend of €1 per share which will normally be approved by the Annual General Shareholders Meeting in May. So that will then give us a group war chest for acquisitions mainly in sterile facilities, eventually non-sterile and also to reinforce our market positions in the Essentials market. Page | 3 Ref 9228158 9 April 2015 Q Fagron Q1 2015 Trading Update Ger van Jeveren: Ok, thank you Jan. That leads to page 8, the final page where we confirm our outlook. We expect to realise turnover from continuing operations of at least €500 million with a REBITDA margin from continuing operations of 26%. Ok, thanks. Operator, you can start Q&A. Operator: Thank you. To ask a question please press *1 on your telephone keypad at this time. Please ensure that the mute function on your telephone is switched off to allow your signal to reach our equipment. Again that’s *1 to ask a question. We’ll pause for a moment to allow everyone the opportunity to signal. We’ll now take our first question from James Vane-Tempest of Jefferies. James Vane-Tempest: Hi, good morning. Thank you very much for taking my questions. I just have a few if I can please. Firstly the earn-outs for past acquisitions, you mentioned a maximum of €45 million in 2015. I’m just wondering if you could remind us what the total earn-outs are for these transactions? I think from memory it may have been closer to €100 million which may have been payable… Jan Peeters: James, the total earn-out until 2018 is €99 million which is the total, maximum earn- outs and we normally don’t pay a maximum. James Vane-Tempest: I beg your pardon, I didn’t quite hear over the line, and that would be payable by did you say in 2018 in total? Jan Peeters: Yes. James Vane-Tempest: Ok. Thank you. Second question is: Could you just give us an update on the status of the warning letter you received in the US, your JCB facility and have all your other US sites been audited? Page | 4 Ref 9228158 9 April 2015 Q Fagron Q1 2015 Trading Update Ger van Jeveren: Typically every 503B organisation in the US is receiving warning letters. That’s an everyday practice James. It doesn’t affect any business whatsoever. The warning letter is just to give notice to the market that for example there was a little issue, but normally it’s about very small issues regarding quality. Although it looks harsh when you talk about a warning letter. When something is really the matter or your operations are not functioning very well, they immediately are closing you down. They stop you from working, so a warning letter is like dayto-day operations. That is an SOP that is not very well established and so on, but normally these are highly standardised GMP FDA approved companies which are really complying to all of the standards. James Vane-Tempest: I understand that there are no quality issues and it’s more procedural in nature. Does that mean your other sites in the US or some of them have received procedural warning letters if it more of a day-to-day issue faced by the industry? Ger van Jeveren: No, but typically now the FDA is more focused on 503B facilities such as JCB which we have in Wichita, Kansas, but that company is doing very well and we are working with the FDA to solve that warning letter. James Vane-Tempest: Excellent. Is that the type of thing you expect that could be solved perhaps by the end of the year or perhaps longer than that? I’m just wondering when you think that you might be able to resolve some of those procedural points? Ger van Jeveren: I will give you an update about that this week, ok? James Vane-Tempest: Ok, thank you very much. A couple of quick follow-ups if I can. You mentioned an improving mix in terms of the overall mix of the Fagron revenues, improving profitability. I was just wondering as a backdrop of that in terms of manufacturing and overall higher costs what the overall compliance impact is, how much of an impact that has on profitability despite the positive developments of the mix of the business? Page | 5 Ref 9228158 9 April 2015 Q Fagron Q1 2015 Trading Update Ger van Jeveren: You are correct. We see that we are profiting from a margin mix in the Fagron company but we also are facing quality costs increasing. However we should underpin that and cope with higher margins. You know people have to pay for the best quality and that’s how we’re organised. Jan Peeters: James, we see an upwards trend in pricing typically in the 503B facilities which is even encouraged by the FDA because the FDA also knows that good quality has a price. James Vane-Tempest: Excellent, thank you. My final question before going back to the queue is the 5.5x EBITDA multiple you’re hoping to spend when you look at your acquisition war chest, I was just wondering from a post synergy perspective whether that’s likely to be higher than what it has been in the past just given the overall increase in compliance and costs faced by the manufacturing side of the business recently? Ger van Jeveren: Jan Peeters: Jan, please. Yes, this depends case by case depending on how quickly we can integrate. Most of the time we have immediate synergies in sourcing, so that’s like low hanging fruit; also in implementing our lean and mean organisation structure which results quite quickly in these type of synergies, although if we acquire these type of facilities, this is quite new in terms of acquisitions, so we will also there have to go through a learning curve I think. James Vane-Tempest: That’s great. Thanks very much for taking my questions. Operator: Thank you. We’ll now take our next question from David Vagman of Exane BNP Paribas. David Vagman: Hi, thank you, good morning. One question about the organic growth: how should we think about the development of the organic growth this year given that you achieved 10% in Q1 and that you will open this new antibiotics facility in the Netherlands in June 2015? That’s the first question about organic growth. Second could you give us more explanation about the Page | 6 Ref 9228158 9 April 2015 Q Fagron Q1 2015 Trading Update contrasting trends in terms of organic growth between Services on the one hand which is very, very strong; and on the other hand Essentials. Thank you. Ger van Jeveren: First reaction on your last question, what we see also is that we are facing some acquisition effect regarding organic growth. For example the pharmacies we bought last year already ordered raw materials from the Fagron Group in Fagron Compounding Essentials and that’s now being reported as internal sales. It’s intercompany sales which is not being reported as turnover of course anymore. That’s the first effect and to be honest I didn’t understand your first question, so maybe you can repeat that? David Vagman: Yes, sure. It’s in terms of development of the organic growth. Should we expect organic growth to increase during the year from the 10% that we saw in Q1 given that you will open a new facility, antibiotic facility in the Netherlands. So basically the 10%, should it be seen as a floor for this year? Ger van Jeveren: Yes, listen, we have said that we are going to achieve 10% organic growth in 2015 and also in 2016 and that’s the outlook we are giving. Maybe you could estimate that there is an upside, however we want to be cautious. We want to deliver what we promise. Thank you. David Vagman: Thank you. Operator: Thank you. We will now take our next question from Matthias Maenhaut of ING. Matthias Maenhaut: Yes, good morning Jan and Ger. A question regarding the organic growth of Fagron Compounding Services. Do I understand well that there is a positive effect from the consolidation in the first quarter of the acquisition of Pharmacy Services and could you maybe quantify the impact that it had on organic growth given your accountancy method for acquisitions? That was my first question. Page | 7 Ref 9228158 9 April 2015 Q Fagron Q1 2015 Trading Update Jan Peeters: The acquisition effect is roughly 10 million so indeed after the second quarter there is no acquisition effect anymore. As of now we don’t have new acquisitions, total growth and organic growth will be the same. Matthias Maenhaut: Yes, but there has been a part that has been quantified under organic growth of those 10 million if I’m correct? Jan Peeters: We took 10 million out. We corrected the historic sales with roughly 10 million in order to calculate the organic growth. Of course if we achieve growth in an acquisition as we do since the beginning, we also take that into account as organic growth. Matthias Maenhaut: Ok, and what has been the growth rate of the acquisition? Could you elaborate on that? Jan Peeters: No, we don’t disclose that. Matthias Maenhaut: Alright. Then maybe a second question, in December there was an update that you were going to actively collaborate with UCM regarding certification of some of your compounding facilities. Could you give an update on how that process is proceeding please? Ger van Jeveren: Yes, so there are already 225 pharmacies in the US accredited to participate in the UCM network. We see an increased amount of participants. This gives us also a perfect basis to have negotiations with PBMs and the government. We are being considered as a very reliable partner and we are profiting from this position right now. Matthias Maenhaut: Ok. Maybe one last one, there was recently a decision by Tricare that they are going to update or change their rules for reimbursement or their processes for reimbursement of compounding medication. It’s an initiative that has clearly been driven by a willingness to contain costs. How do you look at that new process and do you anticipate any negative impact on your sales? Page | 8 Ref 9228158 9 April 2015 Q Fagron Q1 2015 Trading Update Ger van Jeveren: First of all what is the most important outcome of that Tricare announcement is that compounding is totally being reimbursed. In the past, messages were stating that big parts of compounding were no longer reimbursed – that’s no longer the issue, so that’s already the big win, the big gain for us. We are going to profit from that as well, so we are very happy with that. Until this very moment we have proven every day that we are able to cope with an everchanging situation in the landscape of reimbursements in healthcare or especially in compounding. So until this very day especially our US organisation is extremely powerful and extremely capable of coping with changes in reimbursement schemes in the compounding sector, so we are very well positioned to overcome every situation in the US right now which is what we have proven in the last two quarters as well. Again and again this is our daily job for the last 25 years, we are doing an excellent job, given the power of the Fagron US organisation we are even more confident that we are going to be successful and that we will prevail. Matthias Maenhaut: Operator: Ok, thank you. Thank you. As a reminder please press *1 to ask a question. We will now take our next question from Edward Donohue of One Investments. Edward Donoghue: Good morning, a few questions from my side if I may. I know you don’t break things out on a geographic basis anymore but if you could sort of talk through some of the trends in the US market versus Europe especially with regard to compounding services, that would be most grateful to start with. Just to give an idea bearing in mind that you’ve been over there recently I believe? Ger van Jeveren: Can I answer immediately and let’s deal question by question. We see that in Fagron Compounding Services we see especially in the sterile environment that also competitors are approaching us to start negotiations regarding acquisitions. We are happy to do so of course. And as stated in this conference call, we achieved in Q1 the highest amount of prescriptions in the sterile environment in the US ever; also in Europe by the way but especially in the US, that underpins our capability to go with an ever-changing environment in the US. So we are perfectly positioned to build out our sterile division in the US heavily in the coming years. Page | 9 Ref 9228158 9 April 2015 Q Fagron Q1 2015 Trading Update Edward Donoghue: Following on from that, if you look at the US pricing versus your budgeted pricing expectations, if you just look at that overall architecture, how is that developing year to date and the outlook with regards to that in the US, bearing in mind the various changes going on? Ger van Jeveren: You know the sterile environment doesn’t face any reimbursement issues whatsoever. That's only between hospitals and only cash, so that has nothing to do with reimbursements whatsoever. Only relevant for the non-sterile Fagron Compounding Services. Until this very moment we don’t see a decline in the amount of prescriptions that are being compounded in our compounding facilities in the US, so that’s also a confirmation of the quality of the organisation. We don’t see any negative impact on measurements ever until now. Edward Donoghue: Ok. That’s one way of looking at it and I totally agree with you, but that means that volumes are ok but if you look at the pricing of those volumes, how does that actually look versus your expectations for this year just to get an idea how things are tracking? Ger van Jeveren: No, I understand. So especially in the sterile environment we see opportunities, good opportunities, strong opportunities to increase pricing because everybody is supporting a higher quality level in sterile. We don’t want to take any risks meaning we are facing cost of quality but we are also able to increase margins, so that’s the first one. On the second one, the non-sterile compounding services, we see the same amount of volumes but we could face a smaller price increase, but as we stated we are very, very low priced in the market which also gave us a perfect position to talk with PBMs, government and insurance companies. Edward Donoghue: Ok, fine. Then just regarding the M&A pipeline you talk of. When would you expect a conversion of that, of discussions into a closed deal? Ger van Jeveren: In the second and third quarter we are going to give some announcements. Edward Donoghue: Ok. Then just with regards to the spends that you indicated, roughly 100 million. Bearing in mind your dollar denominated debt and the way you have your currency guidance set Page | 10 Ref 9228158 9 April 2015 Q Fagron Q1 2015 Trading Update at 1.25, if I then actually rebase all the currencies to where we are now, does that change anything with regard to your actual capacity to spend? Jan Peeters: No, it doesn’t change. Of course if we do an acquisition in the US, we also convert the local EBITDA in euros, so it doesn’t really have an effect on that. Edward Donoghue: Ok, fine. Then the last question would be just on the moves between United Health and Catamaran. With this sort of consolidation taking place in the industry, do you see implications for Fagron? Ger van Jeveren: So for example, we have an agreement with Catamaran about reimbursement of compounding. So that’s a contract for two years with an extension possibility of five years. Regarding the consolidation that is going on, the only thing what we can say to you about that is that there always is a necessity and a strong need for tailor-made medication globally and that’s a trend we see everywhere in the world. That is the power of the product which proves our capability to cope with every change in the landscape in healthcare. People need it. Edward Donoghue: That I believe. Do you actually have a relationship with United Health? Ger van Jeveren: No, we don’t have a relationship with United Health. Jan Peeters: Our pharmacies are accredited. Edward Donoghue: Yes, but potentially within their PBM business similar to Catamaran you could actually extend the client base potentially via this deal? Ger van Jeveren: Exactly and of course we’ll go to work on that one as well. You know we see that in the future in the US we expect that PBMs and insurance companies are going to buy each other, vice versa or a PBM is buying an insurance company or an insurance company is buying a PBM and that also gives power to consolidation. As we are the number one and market leader in Page | 11 Ref 9228158 9 April 2015 Q Fagron Q1 2015 Trading Update global compounding, we think that we have strong power as well and that we are being positioned as the perfect partner for such consolidations. Edward Donoghue: Excellent gentlemen, thank you very much indeed. Ger van Jeveren: Thank you. Operator: Thank you. We will now take our next question from Solange Timp of ABN AMRO. Solange Timp: Yes, good morning. I have a couple of questions, the first one about your outlook of 26% REBITDA margin because the press release says that Fagron improved the margins of Fagron Essentials each year and also Fagron Compounding Services is the fastest growing part of the business and it generates the highest margins, so with this information my question is how can the guidance for REBITDA margin be lower than last year? Ger van Jeveren: It’s a very good question. We are cautious but we strongly believe in 26%. We have said that for the next three years. When we are feeling the need to change that or to adjust that you are of course being informed by a press release. Solange Timp: Alright, thanks. Another question is about the current reimbursement state of compounded medication in the Netherlands because most of the information is about reimbursement in the US but more recently this also has been a discussion in the Netherlands and as far… Ger van Jeveren: We are very positively surprised by the enormous emotional and powerful reaction of Dutch prescribers regarding the reimbursement of compounding, so first of all the measures are being withdrawn until the end of May. There are now in depth discussions between prescribers, pharmacy organisations and us regarding these reimbursements and we are now facing no effect at all. To state again: we are very positively surprised by the power of this protest against the measures of the insurance companies and we think that we will overcome the situation as a winner and yes, we don’t see till now an effect and we don’t estimate it as well. We don’t expect it as well. Page | 12 Ref 9228158 9 April 2015 Q Fagron Q1 2015 Trading Update Solange Timp: Can you already say something about what you expect after the end of May? Ger van Jeveren: We are still in negotiations with a lot of stakeholders although, as I mentioned before, I think we will overcome the situation once again. It has been day to day business for the last 25 years, so you are looking at something new – but for us it’s daily business. So it’s always about reimbursements, it’s about proving the effect of compounding, that compounding is at least much cheaper for the society as a whole but maybe sometimes a little bit more expensive for an insurance company. For example we are making a lot of bladder infusions for patients who can work because they are getting these bladder infusions. When they are not getting it they cannot work, but the insurance company says it’s expensive. The employer said it’s making my employee working, and at the end of the day we are always able to prove that with compounding we improve the quality of life of the patient and that we are making him more capable of doing his daily job and that’s really paying off. Solange Timp: Alright, ok, thanks. I have another question about the press release because it says that you see increasingly more stringent good manufacturing practice standards and could you tell me how this is impacting the industry as a whole and if it is changing the competitive landscape? Ger van Jeveren: When you look at for example the 503B sterile environment which heavily increased the requirements and demands of quality, we see that a lot of small pharmacies in the US always had a bit of 503B activities. They are now forced to quit or just voluntarily stop with these activities. We see that this sector of our business is coming to us, so pharmacies who have a 503A and 503B capacity are now more willing to stop or forced to stop with these 503B activities due to higher quality demands and requirements. Solange Timp: Ok, so that’s positive for you? Ger van Jeveren: Very positive. Solange Timp: Ok. I also have another question that’s a totally different thing. It’s about the obesity concept you talked about because for example you say that you are operative in a niche market Page | 13 Ref 9228158 9 April 2015 Q Fagron Q1 2015 Trading Update but then I think, big pharma focuses on obesity as well. So how do you differ from these companies? Second what does it look like? Is it pills or a cure you need to do for a couple of weeks just to get a better idea of the product? Ger van Jeveren: Typically we are very, very good in lifestyle welfare diseases especially in Brazil, so Brazil is having a huge knowledge base about obesity concepts. These are being solved very good already in Brazil. We now are starting to cross-sell these concepts, of course a little bit adjusted to the US environment and the European environment. We are going to introduce this in November this year and, if we are going to reach the same success as in Brazil, I think we have a very good end of the year, let’s say that. Solange Timp: Alright, yes. I believe it’s highly successful but could you just tell me what does it look like because for a better understanding, is it a pill or is it a shake? I don’t know. Ger van Jeveren: You are already interested! That’s good. It’s based on the concept of different APIs, totally mixed with a scheme and so on and we will inform you in the third quarter about the introduction of the obesity concept, ok? Solange Timp: Yes, great. Thanks. Ger van Jeveren: Operator: Thanks. Thank you. There are no further questions at this time. Ger van Jeveren: Ok, thank you all for participating in the conference call of the Fagron Q1 Trading Update 2015 and hope to talk to you soon. Thank you, bye bye. Jan Peeters: Thank you. Operator: Thank you. That will conclude today’s conference call. Thank you for your participation ladies and gentlemen, you may now disconnect. Page | 14 Ref 9228158 9 April 2015
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