Laboratorios Farmaceuticos Rovi, S.A. (LRVIY) Earnings Call Transcript & Summary

Good afternoon, and thank you for joining us for this special conference call to discuss ROVI's acquisition of an injectable drug product manufacturing site in Phoenix, Arizona, which we announced yesterday. Joining me on the call today is Juan Lopez-Belmonte, ROVI's Chairman and Chief Executive Officer; and Javier Lopez-Belmonte, ROVI's Deputy Chairman and Chief Financial Officer who will discuss the strategic rationale for the acquisition as well as the key terms of the transaction. Javier is in Phoenix and he doesn't have a good coverage. So we hope he can stay connected throughout the event. You will see a big presentation deck in the Investors section of our website. We'll work through that deck on the call. And after that, we'll open it up for Q&A. If you want to ask any questions during the presentation, please don't hesitate to send them through the question bottom on the platform. Before we get started, I note that some statements we may maybe consider forward-looking statements based on our current beliefs and expectations. Actual results could materially differ due to known and unknown risks, uncertainties and other factors, and we undertake no obligation to update or revise any of the statements. So with that, I thank you for your presence here today. And we'll now hand the presentation over to Juan Lopez-Belmonte, please go ahead.

Thank you, Marta. Good morning, and thank you for joining us today. This is truly an exciting day for ROVI. I'm very pleased to announce our agreement to acquire ROIS Phoenix, a sterile fill & finish drug product manufacturing and packaging site located in Phoenix, Arizona. This next slide provides a quick snapshot of ROIS Phoenix. The facility has a well-trained and highly experienced workforce, I would also like to mention that there had been significant CapEx investments made in the facility over USD 100 million since 2021. It's a big site. It has a total size of 34,000 square meters, situated on 80,000 square meters of land, which leaves ample room for expansion. It's a state-of-the-art site with cytotoxic area that has been approved by the FDA, EMA, Japanese agency among others. And we will continue to upgrade capabilities within the site. And as part of the agreement, we will be installing a new optima pre-filled syringe filling line with isolator technology. So this line is expected to be installed in a segregated area in 2027 and will add a capacity of between 65 million to 70 million prefilled syringes per year. And to end, as part of the agreement, we have entered into a Toll Manufacturing Agreement with Bristol-Myers Squibb and its affiliates from whom we have acquired this site. Through this agreement, ROIS Phoenix will engage in a 5-year supply agreement for a yearly fee of USD 50 million. As you can see in this next slide, the facility is divided into three main areas: Building A, which houses all current manufacturing and laboratory facilities, warehouses and administrative offices. Building B, warehouse space. New Shell. This is a new building that has been recently constructed. In this building, we will include the new optima line, thus expanding our PFS filling capacity. However, as you can see from the figures on the screen, there is still plenty of space for building a segregated area for manufacturing biologic products. This transaction makes a unique value proposition for our biopharma customers even stronger. It not only offers the ability to manufacture products in U.S. soil, but also adds highly competitive, high potent OEB5 cytotoxic capacities. In coming years, and in line with ROVI's expertise and long-term strategy, the facility is expected to house the production of many more high value-added products such as obesity products, vaccines, biosimilars or biotech drug products, monoclonal antibodies and ADCs. And you may be wondering why Phoenix? Phoenix is the fifth largest city in the United States and has been among the fastest growing cities in the U.S. in recent times. There are also several trends that make the city very attractive for the manufacturing site. First, let me begin with its attractive location. The site is located like 10 kilometers away from downtown Phoenix and 17 kilometers away from Phoenix International Airport. It is also two blocks away from the Interstate 10, a major East West Freeway that runs across the Southern U.S., including to Phoenix and Loop 202, a beltway around the Phoenix metropolitan area that connects to the Interstate 10 multiple times. The site locations ensures seamless inbound and outbound logistics, which is key for our manufacturing site. Second, Phoenix is a city with access to talent. Its proximity to universities provides access to specialized professionals. The city is also attracting aviation and semiconductor industries, which are recruiting skilled talent to the area. Third, Phoenix is a growing life science city, has a life science innovation district with over 550,000 square meters of planned life science development. And finally, as you all may know, there is a desirable climate with limited risk of earthquakes, floods or landslides. The acquisition of the new U.S. facility represents a significant step in ROVI's long-term strategy to invest in advanced manufacturing infrastructure, equipped to handle commercial scale production of injectable medicines. This site enhances ROIS' ability to offer end-to-end CDMO services across multiple geographies. ROIS Phoenix is a great strategic fit. With this expansion, ROIS managed to get a broadened global manufacturing network by adding a new state-of-the-art site, enhancing injectable capacity, strengthening partnerships and supporting the supply of medicines. Expands ROIS high-value injectable capacity to develop and manufacture injectable medicines at commercial scale, enabling the company to serve pharmaceutical and biotech customers directly in U.S. soil, while continuing to build on its strong European base. Enhances ROIS's know-how and capacity for manufacturing high-potent OEB5 cytotoxic injectable products. Strengthens ROIS's commitment to innovation and investment in cutting-edge facilities and equipment. Lastly, scales ROIS's U.S. sales team to capture new growth opportunities. Today's announcement is a key milestone that enables us to achieve our goals, our vision to be a worldwide player in high value-added injectables. Javier will now explain the key terms of the transaction.

Thank you, Juan, and good morning to everyone from Phoenix, Arizona. Good morning here and my Internet connection, as Marta was explaining to all of you, it's not very good. I hope it will work during the call. It's a truly exciting day for ROVI. As Juan has explained, ROVI has acquired via its subsidiary, ROIS Phoenix, the facility located in Phoenix from Bristol-Myers Squibb and its relevant affiliates, for a price, which is not material for ROVI. As a part of the agreement, ROVI has entered into a Toll Manufacturing agreement with BMS, which regulates the conditions under which ROIS will continue to manufacture for BMS at the facility, with the necessary personnel as of the closing date to enable its operability. This agreement has an initial term of 5 years from the closing of the transaction and provides for a minimum payment to the buyer of USD 50 million for each year of the contract. Turning to completion consideration. The acquisition price is subject to customary closing conditions, including obtaining regulatory approvals and no material adverse change occurring prior to the completion of the transaction. We expect those completion of conditions to be satisfied in the first half of next year. Leading up to close, we'll be preparing for the integration of ROIS Phoenix into ROVI following a planned integration strategy to facilitate a smooth and seamless transition. Our strategic view for the midterm future of the Phoenix site is clear, I would say. We will continue to manufacture for BMS. We will implement the new PFS Optima Line in the New Shell. We will conduct a growth assessment of the potential expansion of the New Shell, and we also conduct a growth assessment of expansion alternatives in available areas in Building A and in the rest of the land that we have there. Please bear in mind that this is going to be possible, thanks to the skills, dedication and talent of ROIS Phoenix workforce, which is very important in the U.S. Thanks to their work, we are equipped to drive the continued growth of our facility. And through the integration of ROIS Phoenix to the ROIS network, we achieved our vision of becoming a global CDMO player. So ladies and gentlemen, today, we announced the rebranding of our CDMO business to ROIS brand. This move marks a major step in the company's transformation into a truly global contract development and manufacturing organization. So welcome, everybody, to ROIS. ROIS is one of the top 3 largest CDMO injectable companies worldwide and one of the biggest CDMO players in Europe. We have 4 fully invested sites in Spain and now 1 in Arizona, U.S. We employ more than 1,400 employees through our network, manufacture for more than 30 top-tier global pharma companies, and we are compliant with for all geographical regions where we operate. ROIS has a large experience in the manufacture of vaccines and biosimilar/biotech drug products. What distinguishes us from our competitors? I would say, our scale, speed and quality. And this is ROIS today, 4 state-of-the-art sites in Spain and 1 in Phoenix, U.S. The expansion into the U.S. underlines the company's vision to be a partner of choice for injectable medicine worldwide, backed by continuous investment in people, technology and infrastructure. We are now better positioned than ever to deliver to our clients' expectations while preparing for the current and future growth of the global injectable market. Through the integration of ROIS Phoenix, we are -- we will increase our current capabilities. If we turn to the next slide then, we will provide a snapshot of ROIS's capacity post ROIS Phoenix integration. We'll add 2 new aseptic filling lines, a vial line already in operation and a new PFS line with isolator technology. This PFS line already bought is expected to arrive in the last quarter of the year, but will not be operational until 2027, and it will add between 65 million to 70 million, probably millions of PFS units capacity. As part of the current agreement, we also add a new packaging line that is already in operation. So I would like to conclude by echoing Juan's excitement about the transaction and the benefits we expect to deliver to clients. Today, we reaffirm our support for our partners in the pharma industry. ROIS Phoenix's strong capabilities will significantly strengthen our unique value proposition for these customers. This transaction, sorry, also give us entry into the booming CDMO U.S. market, large and fast growth market that opens exciting opportunities for us. Before closing, I'm very proud to take a moment to highlight the tremendous value this transaction brings to our stakeholders. Over the last years, we have built a leading presence in the CDMO industry with exciting growth potential. Bringing ROIS Phoenix on board is all about continuing this momentum. I must point out that this achievement wouldn't be possible without the hard work of our talented team. We are confident that this transaction represents the right strategic move and a natural step in our company's evolution. Together with ROIS Phoenix, we will unlock even greater value for our stakeholders. Please remember ROIS Phoenix is a great business in a growing industry. With that, I'll turn the call -- sorry to Marta11 again for Q&A.

[Operator Instructions] So the first question comes from Francisco Ruiz from BNP. Javier, it's for you. Could you give us an idea on what would be the EBITDA contribution from the USD 50 million -- sorry, for the $50 million in yearly contract with BMS. If the Optima line is already invested, why BMS will give it almost for free once you were asking for a significant valuation for your business last year?

Thank you, Francisco, for your questions. Starting for the first one around the EBITDA contribution of this $50 million contract. I would say that the importance of this agreement with BMS is that will allow the new ROIS Phoenix company and facility to enlarge its operations meanwhile it's working and manufacturing to BMS as it was doing before this transaction. In terms of economic return, we are not expecting to be accretive during this first couple of years, at least. And once we start offering the facility to new customers, bringing customers will provide significant profitability to the facility. So meaning that this agreement will cover the cost of the operation of the plant meanwhile, we attract new businesses, which we hope that we will be able to do it, thanks to our reputation and well known of the market. And then once we get new customers, we can really leverage the capacity of the facility, and therefore, we will be able to bring operational leverage to the company and add a significant profitability to ROIS Phoenix. With regards to your second question, we think it's a fantastic deal also because we are adding new PFS equipment and capacity almost since the closing of the transaction, and that will help us to attract new businesses very soon. Unfortunately, this business, you need to be patient. And I think that's the vision of ROVI and ROIS that we invest for the long term, and we invest for our long-term view. I mean it's clear to me that BMS is in a restructuring mode as a company. They are making different cost containment measures. And probably one of the ideas behind the selling of -- the facility is to decrease the number of sites of their network. Again, we don't have internal info about BMS. What we can tell you, is it's been very hard to convince the BMS that we were the right partner. And for them, probably price and valuation was not that important. You have to bear in mind that BMS is a multibillion market from a company, a blue chip pharmaceutical company, and we are going to manufacture for them in the next 5 years. So for BMS, what it was more important is to have the right partner in place because they are going to rely on ROVI, at least for the next 5 years for products that they are currently selling and they have an important added value for them. So I believe the profile of ROVI and ROIS has a worldwide CDMO injectable manufacturing partner was far more important than the valuation of the assets and the valuation of the transaction.

The next question comes from Álvaro Lenze from Alantra. Javier, given the plan imbalance in the injectables fill & finish space, how is an asset like this being sold below its replacement cost? Do you know what other bidders were looking for?

Well, this transaction was conducted with a financial adviser by BMS. So it was a competitive bid and tender. And again, let me highlight that from our point of view, what we had to manage to deliver to BMS to the seller was not that much the price that we were paying for them for the facility, but our capabilities and our strength to commit with BMS needs for the future. Again, the product or the products that we will be manufacturing, it means, I would say, a lot to BMS and its network. So for them, the continuation of supply. And again, giving an opportunity for their talented employees to have a career in the injectable world, I think it was far more important than the price that we were paying to them. It hasn't been easy at all. We've been working in this transaction for several months with a full team dedicated to convince BMS and its adviser that we were the right partner for the ROIS Phoenix site or the Phoenix site. So I think, again, overall, our value proposition for the long term, what's more important for BMS that the short-term price that eventually any bidder could place on the table.

Thanks, Javier. Álvaro also asks, should we expect any margin at the EBITDA or EBIT level from the 5-year contract with the BMS?

I mean, which is very important or at least was very important to us in the negotiation process, it's this 5-year agreement allows us to develop the site. And as we were mentioning in the presentation, it provides us with 5 years to install new lines as the PFS one already bought by BMS that will attract new customers also for the current cytotoxic line. So with these potential new businesses, we could add a significant profitability to the site. With the current agreement, what we make sure is that this site can operate in a normal way and cannot -- and it is not going to be a burden for the rest of the company. So it's a magnificent opportunity that we can keep growing this site as we have done in the past with others. And for sure, the first couple of years, we don't expect this site to bring additional profitability to the business, but it opens a tremendous opportunity for the company in the medium term. As everybody knows, with the current geopolitical situation, all companies are trying to look also for being their products manufactured in the U.S. -- manufacturing in the U.S. So I think it's a tremendous opportunity for ROVI to offer this site for customers and clients that they want their products manufactured in U.S. soil.

Thanks, Javier. The next question comes from Tim Jeck from Entrepreneurial of Investment. Javier, it's for you. Can you be more precise what not material means, example, less than 1% of market cap?

I mean we would have loved to provide the market with the price. However, our agreement with BMS doesn't allow us to give visibility on the price, which meaning that is not material means that it's not significant to ROVI now. I would say that it's a good assessment that is below 1%. I mean we cannot give transparency on that, but it's not meaningless to us -- it is meaningless to us, sorry.

Thanks, Javier. Juan, the next one is for you. It comes from [indiscernible]. Do you think that there could be a potential to move some of current or future Moderna production into this plant? How do you plan to articulate the marketing of this new capacity with the existing capacity in Spain, namely to U.S. customer?

Thank you for your question. As Javier has mentioned before, and we have reiterated along the call, I think this is a magnificent movement by ROVI on operation to really scale up our contract manufacturing operations to a global level. I mean we like having a facility in U.S. soil, and this is what we get with U.S. Phoenix. I believe this is going to be a very attractive alternative to all our existing and future potential customers. As Javier has mentioned, and I have emphasized in my initial presentation, we're going to enlarge our commercial team in the U.S. And I think that's going to provide us a tremendous opportunity, probably Moderna, but not only limited to Moderna, but many of our existing customers or future potential customers, having the optionality within ROIS to have their operations and their manufacturing activities done in U.S. soil is a tremendous thing. I mean, I think this is going to be a landmark. This is going to change the evolution of ROIS as a CDMO. And I'm pretty optimistic that this is just going to be the beginning of a very exciting future of ROIS as a CDMO global injectable player.

Thanks Juan. The next question comes from Charles Weston from Royal Bank of Canada. Javier, it's for you. You described the $50 million per year as a minimum. Could it be materially higher?

Yes, why not? I mean, BMS, it's a great blue-chip company. What it was important to us is that we have a minimum commitment that whatever happened to BMS or the products, we have this minimum income coming in on annual basis. Again, but as Juan has just mentioned, our focus will be to expand to new customers. That will be the main goal. But yes, why not to say, it could -- this figure could be increased in the next years, which is also -- or it was very important to us is that with this new transaction, we are adding a tremendous and important customer to our company, which is Bristol-Myers Squibb, which is a multibillion pharmaceutical company. So whenever you start working with a company of such size, you never know the opportunities that lies ahead of you.

Thanks, Javier. The next 3 questions come from Jaime Escribano from Santander Group. The first one, Javier, is CapEx left to unlock the new Optima capacity?

Yes. Thanks, Jaime. This is -- we are working on that evaluation. One of the things that we have to do, as described in the presentation, is to assess the future of the facility. For sure, we are going to invest on this new PFS line. For that purpose, we need to do some investments to install the line. Again, I don't see those as a major investment. But again, we need to reassess once we close the transaction, the CapEx for this site for the next year. But what I believe right now, it's given for us is that in order to install this line, we'll need to implement some investments, which could be between USD 20 million to USD 30 million, but still the fine number, we still have to work it around with the people there in the next coming months.

Thanks, Javier. The next question from Jaime is potential peak revenues of the new Optima line. What will be the key challenges of this project?

I mean what we are truly excited is that this line could be in operation from -- as Juan mentioned or I believe I mentioned since 2027, meaning that we can offer the line to the customers, I think, since today. Since today, our salespeople will start offering this line to our -- first to our current customers and second to the potential new customers. You know that time is very -- in our industry, companies move in a very slow motion in the sense that everything has to be anticipated by a few years in advance. So probably, as we have done with our lines in Madrid, in the next coming months, we'll start trying to negotiate with customers for this new line. Big line peak sales is always very difficult to predict with this capacity and with the current conditions of the market and our current customers. I mean, it's easy for us to predict that this line could eventually have revenues I would say, easily more than USD 100 million of revenue. But again, it's very premature to say the revenues that potentially come from a line that is not yet -- that has not yet arrived. So it will depend on the market situation and the current conditions, but we are really, really excited about the potential of this line. And I'm sure that we'll have a queue of customers trying to book some millions of syringes for the future coming from this line.

Thanks, Javier. Juan, Jaime also asks, did you work with Bristol before? Can leadership lead for future collaboration, example, being a customer of CDMO in Spain?

I mean, as Javier has mentioned before, I mean, BMS is one of the largest pharmaceutical innovative companies worldwide. I mean, to some extent, probably it happened many years ago, we did a similar deal with Merck, the American company back in 2010. And Merck is still a customer of ours with different products that we initially contracted with them when we bought the Alcala facility. So definitely, I mean, we never worked before with BMS, but definitely working with BMS, trying to be partnered with them, being proud to be, as Javier mentioned, to be chosen by BMS to be their partners and acquiring a manufacturing facility. That means that they really praise our company and our business continuity model for their production of one of their key products. So again, we're very excited because getting a new site, cytotoxic line, vials with additional prefilled syringe capacity and on top of that, having a 5-year contract with BMS, which is also a tremendous added value. And definitely, we will work hard to try to build up this relationship and try to enlarge our existing relationship with BMS to additional products for contract manufacturing.

Thanks, Juan. Javier, the next question is from Javier [indiscernible] What is the estimated investment required to add a new line at this site?

Again, we have done a global evaluation of the potential of the site. Let me rephrase as Juan was saying before, that it is not only about the potential new lines, but also the current capacity, which we are including or adding cytotoxic capabilities to our network and lyophilization capabilities. These are key for us because we were lacking in these sort of capabilities in our current network. So let me highlight it, not to visualize wrongly from our investors that the current capacities are great. And on top of that, we are adding this new PFS line for biological production, which you know we are experts on that currently. And on top of that, the importance and the strategic view of the site is that it's a huge site. So we internally talked that we see this site as the current Alcala site, just to visualize for our investors, the -- how big the site is. So it's a huge land and a huge buildings that we are buying. So we have plenty of space, plenty of room to add new capabilities and services. Again, the U.S. market is different than Europe and Spain. So any investment there need to be reassessed because the numbers in the U.S. are higher in terms of cost than in Europe and in Spain for sure. But this is the process that we'll be doing again once since today that we have closed the transaction or announced the transaction. So first, we have the current capabilities; second, this new line. And third, we need to do a fine-tune of what we lack in our network or what is -- what our customers want from us. And I think we have the opportunity to deploy that in Phoenix because we have the people, the room and with ROVI and ROIS, we have also the capital and the money. So it's something that we'll need to further evaluate and probably we'll be updating everybody in the next coming months.

Thanks, Javier. Juan, the next question is for you. It comes from Chris Richardson from Jefferies. Is it fair to assume this site was being run below an optimal level like the Roche site purchased by Lonza? Do you plan to phase out BMS products? Or do you hope to phase BMS products out and bring in third parties?

Again, I mean, I think this is a very exciting opportunity. I mean BMS is a fantastic partner and potential future customers. I think we now have to work hard to gain the trust of BMS beyond this agreement. As I put example before of Merck in 2010, today is one of our major customers. I think we have to really work out the trust on BMS management to prove them that we can run the company with -- I mean, with the efficacy and the efficiency that they did prior to the operation. I cannot then tell you, how did BMS run the facility, whether it was at an optimal level in terms of capacity. But definitely, we do believe that the added value of this transaction is really very significant for ROVI. I don't want to repeat ourselves, but prefilled syringes, again, we have installed several similar lines very recently in our facilities in Madrid. We know the landscape. We know the customers. We know the markets is on Optima. I don't want my memory to fail me, but probably it's the fourth or the fifth Optima line that we have installed in our manufacturing network. I mean the line is going to be delivered in the next coming weeks. So that's as well a major positive thing. And again, we -- I mean, we know this landscape very well. So we are going to start offering our services on prefilled syringes from today. And I'm pretty optimistic. I think this is going to be a tremendous landmark and it's going to be a turning point and the perception of ROIS as a real global CDMO operation. As well as Javier has highlighted, having the cytotoxic vial line with lyophilization capacity, it offers as well the broad of our services. In nowadays, supply chains are getting completely redesigned. Big pharma companies, they want to work with very few contract manufacturers. It takes a lot of money and time and dedication to have different contract manufacturers. And I think this operation works positively on that sense. The concept of one shop, we can offer different services. We can offer those services in the 2 major or largest pharmaceutical markets, the U.S. and Europe with a top quality level. I mean, we cannot forget this facility is already being approved not only by the FDA, but by EMA, by the Japanese agency, by most of the major geographical regions. So I think altogether, it's really a jackpot. I mean I think definitely for ROIS, this is going to be a real landmark in our CDMO history. And we're just very excited and looking forward to providing more substantial good news in the next coming weeks and months to our investors.

Thanks Juan. The next question comes from [indiscernible] Javier it is for you. Bold move guys, congratulations. Are you seeing higher interest from your clients now that you have the factory in U.S. soil and BMS as another large client?

I mean we just announced the transaction yesterday. So what I can share with all of you is that we've been congratulated by many people. And apparently, so far, nobody has told us that we are wrong in our view or in our assessment. It's still early to talk about new customers because this has been very strictly confidential transaction. So I hope that this is new for everybody, also for the customers and for the manufacturing industry. But I'm sure that from today, we have already started to communicate our customers that there is an opportunity to book a capacity in the U.S. soil and that they can trust on our ROIS capabilities to bring new products to this new site.

Thanks, Javier. The next question comes from Joaquin Garcia-Quiros from JB Capital. Javier, this is for you. Does BMS has an optionality to renew the contract after the 5 years? Or will you be free to offer that capacity to other players?

I mean the contract/agreement, I'm afraid, is very, very strictly confidential. What I can tell is that BMS has the ability -- I mean, we have to manufacture for BMS for 5 years, and that's a fixed agreement and with minimum quantities and value. And from that period onwards, let's say that it has to be agreed between parties.

The last question is for you, Javier. It comes from Pablo De Renteria from Kepler. I understand it's difficult to assess the potential revenue and profitability of the Phoenix plant at this stage. However, in the long run, would you expect margins at the site to be broadly comparable to those you project for your CDMO business in Spain by 2030?

Well, thanks, Pablo, for your question. I mean, what we are working right now or since we started to analyze the transaction is that we can enlarge the output of the facility firstly, from the current line and second, from the new equipment that is coming. And as we have shared today, once we increase the output of the facility, we can deliver a very strong, I would say, massive operational leverage as it's how this business works. Once you start adding additional revenue, the additional revenue is very profitable. Again, it's difficult to make such a statement, but we believe so that once this facility is working with -- at a full speed or with more customers on board, we do believe that this business can be very profitable and probably as comparable as our Spanish business.

Thanks, Javier. We are out of time. Thank you very much for your high participation. The IR team will answer the outstanding questions as soon as possible. I'll turn the call over to Javier for the closure of the presentation.

Thank you, Marta. It's been a pleasure to be with all of you today. For us, the acquisition of this facility in Phoenix, it's for sure a turning point in our history and a landmark. So I'm very happy or we are very happy to share with you this call and to comment on the details of the transaction. And there is no more time. So thank you for joining the call today, and have a good day. Thank you. Bye-bye.