Good morning, good afternoon to the call, Capital Markets Conference Call by UCB. My name is Antje Witte. I'm heading Investor Relations at UCB. We like to talk to you today about our agreement we did with Zogenix to acquire the company. Before we start with our presentation, I'd like to highlight some details. Please be informed about this important information about the tender offer. This tender offer, as laid out in the presentation and in the press release this morning, has not yet started. This call and the press release are for informational purposes only and are neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Zogenix or any other securities. I kindly ask you to read this slide carefully.
On the next slide, I have to make you aware of our disclaimer and forward-looking statements. This is a traditional disclaimer you find in our presentations. We are talking about future events, potential future events, and we urge you to have a close look to this disclaimer and forward-looking statements, please. Thank you very much. Now I'm happy to hand over in a second to our CEO, Jean-Christophe Tellier, who's going to lay out the strategic growth path of UCB. Charl van Zyl, our member of the Executive Committee and Head of Neurology, is going to talk to you about UCB and Zogenix serving people living with epilepsy. Our Chief Medical Officer, Iris Löw-Friedrich, is introducing to you the two indications we are talking about.
Last, of course, but not least, our CFO, Sandrine Dufour, familiarizes you with the transaction terms and the funding. At the end, I will come back to you with the Q&A features. I'm happy to hand over now to Jean-Christophe.
Thank you, Antje. Good morning, good afternoon, everyone. It's a pleasure to welcome you to our capital markets call and to give you more detail on the acquisitions of Zogenix that we aim to achieve. If I can go to the next slide, please. I think my objective today is to try to quickly explain to you why we found that this deal is almost a perfect strategic fit with UCB today. I would like to illustrate that through three lenses before handing over to my colleagues. The first lens is an alignment with our purpose and our patient value strategy. As you know, we at UCB always have the aim to deliver differentiated medicine that can help patients suffering from chronic diseases.
Here we are talking about two, and Iris will comment about that. We are talking about two very severe, rare chronic form of epilepsy that are very difficult to treat, Dravet and Lennox-Gastaut syndrome. The product is already launched. FINTEPLA is already launched in Dravet, is in the filing stage for Lennox-Gastaut. In Dravet, in phase III, the products have already demonstrated a very significant achievements, which mean that the product is on its track to become the potential new standard of care, and Charles will comment about that.
Definitely, I think we can, and we can agree that from a strategic fit and from an alignment, from a purpose and from a patient value perspective, we have with Zogenix a potential partner that can really help these patients and complement the portfolio that we have by adding a solution that will help patients that are in a tremendous need today. The second element of this strategic fit, the second lens that I would like you to take is the epilepsy one. You know, at UCB, we are committed to epilepsy. We are already leading for these patient populations. We aim to continue to lead, and it's one of the five patient populations that we aim to lead by 2025. We of course have a strong commitment to epilepsy.
This has been the case for the last 20-plus years with product like Keppra, VIMPAT and BRIVIACT and others. The FINTEPLA is a perfect match to add to what we currently have. It's adding a new population, and it's adding a new treatment that will complement what we have by treating very specific patients for a very specific disease that we are not currently addressing. The second lens is the epilepsy lens and to try to understand the strategic fit. The third lens is the sustainable company growth lens. You know that we are aiming to grow and to continue to grow. This potential acquisition will give us an ability to accelerate our growth. It will be accelerating this growth after closing, of course.
Sandrine will talk to you more about the timing and the different element of these questions. It will be an additional revenue for us after closing, and it will be accretive to UCB's earnings. From 2023 onwards, as you can see here, which is an important element because from a timing standpoint, it's also a perfect timing for this acquisition because we are entering into a phase where we will lose exclusivity for VIMPAT. That will give us an additional growth engine into the neurology, and particularly the epilepsy franchise. Next slide, please. It's just in a nutshell, and my colleagues will go a little bit more into detail of that.
On top of the strategic fits, as you can see the considerations and the values, Sandrine Dufour will talk about that. On the funding part, we think that we are in very strong positions in order to be able to close this with just EUR 800 million additional loan and from available cash resources. In terms of timing, now that it's been approved unanimously by the board of both companies, we expect to close by Q2 2022, which is also for us, an important element. In terms of amount and financing amount, as you can see here, $1.9 billion in equity values, equivalent of EUR 1.7 billion.
In a nutshell, a very strategic and important deal for us that will complement and continue to nurture our strategic ambitions to deliver differentiated product for very specific patients population. A strong additions to our epilepsy portfolio, and on a timing coming in a moment where it will accelerate our growth and be quickly accretive. That's the reason why from a strategic standpoint, I think it makes for us perfect sense. With this, I would like to hand over to Charles.
Thank you, Jean-Christophe. Also, I want to take this moment to welcome everyone to the call and thank you for joining today. Of course, we are delighted, you know, to announce this deal today, and it's really an opportunity to further strengthen our leadership position in epilepsy. If I could go to the next slide. I wanted to just remind you for those who may not follow us that much, that, you know, we have a history of more than 20 years in epilepsy and in this space and have been recognized and continue to be recognized as leaders in this space. It is really, you know, just not just the product, but also beyond that.
You know, our investment in research, our collaborations on many fronts have really made us a leader in this space over the last 20 years. With this acquisition, we even further extend our compelling portfolio that we have. If you know us, then you will know that we have three very strong treatments, solutions for patients that treat the symptomatic space. Of course, our history with Keppra. We have VIMPAT, of course, and we also have BRIVIACT there. Also through the acquisitions in the past two years, we have also been able to enhance that portfolio in the drug device combinations for the acute stages of seizure and rescue medicines. In this case, Nayzilam, and we also have Staccato in phase III that will also enter into this space.
Now with the acquisition of FINTEPLA into our portfolio, we are able to address the patient population that we've never been able to address before, Dravet and then also LGS in the rare space. With these, you know, combinations of these portfolios, of course, we really now have very compelling offer for patients and solutions for patients across a wider spectrum. If we go to the next slide, then again, I want to, you know, reiterate here today, of course, our commitment to the long- term in epilepsy, and this is another signal and a very strong signal that we are very committed to this space. There is still a very high degree of unmet need and a number of patient populations that are underserved.
We are really very committed to this space and very clear also with this acquisition that we are here for the long- term. As we said here very briefly, we are focused, of course, on maximizing a very compelling portfolio and of course very excited with the acquisition and addition of FINTEPLA into that space. We have developed also other elements beyond just the scientific solutions, but of course digital solutions as well to ensure patients have this seamless experience when they're treating with epileptic solutions, of course, and also how they interact with physicians and with others. We're very much focused beyond just the solution, also on the ecosystem and how we can act as a leader across many dimensions, of course.
Then we are investing and continue to invest, of course, in early science and discovery and deeper understanding of the pathobiology will lead us, of course, into many solutions and the next wave of innovation that will follow beyond what we have today. Really very strong, compelling story and a strong outlook also for epilepsy for the future. If I go to the next slide, then really a very brief overview of Zogenix. I wanna take this moment also to recognize the great effort and the great value that the Zogenix leadership team have created here with within the company that they have today. It's really a company that we see as a great match for us.
You know, they are value-driven as we are towards patients and bringing differentiated solutions to patients. Also very pioneering company that has really taken FINTEPLA and in a new indication and taken that risk and made that significant investment with three phase III programs to, you know, bring a new solution to patients with Dravet and LGS. They've been rewarded with an orphan status in both U.S. and in Europe. This is clearly a recognition of being a pioneer, taking a risk and building a fantastic solution for patients that we are now able to partner together with to bring to these patients. As a final slide, if I can go to the next slide. Again, I want to just reiterate what Jean-Christophe Tellier had mentioned. It's a clear excellent strategic fit.
It's a smart deal for UCB. We are able to now access a highly differentiated asset that can bring differentiated solutions for patients with Dravet syndrome and Lennox-Gastaut syndrome. It is regarded by many of the thought leaders as a gold standard in terms of its efficacy profile, and so we're very privileged to be able to have such an asset now in our portfolio in the future. Very strong strategic fit, of course, and with our leadership infrastructure in epilepsy, we are able to reach more patients and provide patients this solution through our very strong relationships and global reach that we have as a company in epilepsy. The final point that has been reiterated, of course, is the attractiveness as a smart deal to be accretive on growth, of course, and also on profit in the short -term.
Really also helping us to continue to bring sustainable growth for the company over the next five to ten years. With that, it's my pleasure to hand over to Iris to provide you with more of the clinical profile of our acquisition. Thank you, Iris.
Yes. Thank you very much, Charles, and also from my side, a warm welcome to all of you, and please move to the next slide. As we all know, the epilepsies are a group of heterogeneous neurological conditions characterized by very different types of seizures and around the world probably affecting more than 60 million people. We also know that the biology of epilepsies is poorly understood, and structural, genetic, infectious, metabolic, immune, and neurodegenerative causes have been postulated. With recent advances in science, the etiology of many epilepsies has become clearer and will result in more targeted and eventually, hopefully, also disease-modifying therapies. Currently established treatment paradigms focus on a few broad mechanisms of action and have resulted in seizure control for about 70% of the people living with epilepsy, while roughly 30% of patients remain drug resistant.
We are focusing on these 30% and improving the lives of these patients with uncontrolled seizure burden is, of course, very much of our interest and in our focus. These patients include rare populations with life-threatening risks and serious impact on quality of life. Among them, there are two catastrophic epileptic syndromes with onset during childhood, Dravet syndrome and Lennox-Gastaut syndrome. We move to the next slide, please. Just imagine the happiness of parents with a newborn baby that is healthy and that's developing well. Just a few months old, maybe following a fever, the infant develops generalized convulsive seizure. Episodes where the entire body is shaken by muscle cramps, and these episodes now staying very long, each time maybe for an hour or even longer. These seizures occur very often.
Imagine a life with countless emergency room visits and ICU stays with life-threatening episodes of status epilepticus or respiratory arrest. Of course, these thousands of seizures in the early years of life result in severe delays of development, in substantial motor and cognitive deficits, and have, of course, also behavioral consequences. This is the typical life with Dravet syndrome. It is a lifelong rare disease with probably 20,000 patients and their families affected in the U.S. and also in the European Union. More than 80% of these patients are not controlled with treatment. The hour-long episodes of generalized convulsive seizures are very difficult to terminate, even under hospital conditions. They result in a 20% mortality rate and a substantially increased risk to die of sudden unexpected deaths in epilepsy, SUDEP, or respiratory arrest.
Effective seizure control, extension of the intervals between the seizures, and improved cognitive development are very key unmet needs. Please move to the next slide. We are confident that FINTEPLA can make a difference for children with Dravet syndrome and their families. This is based on the data from positive phase III trials, which resulted in the approval in the U.S. and in the EU. The clinical trials have shown a median 70% reduction from placebo in monthly convulsive seizures. The mean longest interval between seizures was increased by more than 10 days from placebo. Open-label extension studies show a sustained effect with 80% reduction of seizures at three years. Medically, these improvements are very meaningful and of course contribute to an improved quality of life.
The mechanism of action of fenfluramine, the active ingredient is via the release of serotonin and comes with the mechanistic risk of valvular heart disease and pulmonary arterial hypertension only at high doses. Hence, FINTEPLA is subject to a risk evaluation and mitigation strategy. The FINTEPLA REMS runs in the U.S. and the controlled access program in the E.U. with regular echocardiographic follow-up. This enhanced vigilance has not shown any safety signals so far. Lennox-Gastaut syndrome is another catastrophic childhood epilepsy. Positive phase III results with a clinically meaningful improvement in drop seizures, the characteristic seizure type in this population, and important efficacy in the reduction of generalized tonic-clonic seizures are the foundation of the regulatory filings in the U.S. and E.U. Next slide, please. Lennox-Gastaut is also a rare epilepsy syndrome with onset typically at the age between two and seven years.
It affects up to 100,000 patients, and again, families are always affected severely, just in the U.S. and in the European Union with these numbers. Patients with LGS experience many different types of seizures. Atonic seizures with a sudden loss of muscle tone and falling to the ground, the so-called drop seizures, are very typical. The generalized convulsive seizures are also frequent, and they are the reason very often for SUDEP. The burden of the disease with its increased mortality and the high risk of SUDEP, the developmental, cognitive, and behavioral impact, and the refractoryness to treatment are very similar between LGS and Dravet syndrome. In both diseases, of course, early diagnosis and the multidisciplinary care team are required to mitigate the severe impact on quality of life and development.
As you have heard and know, we have a very long-standing commitment to children living with epilepsy in UCB. We have demonstrated this with comprehensive and innovative development programs of our current portfolio of anti-seizure medicines in pediatric patients down to the age of one month and even including neonates. The addition of FINTEPLA to our portfolio with a different mechanism of action and addressing different patient populations will broaden our offerings to the people living with rare catastrophic epilepsies. With that, I am pleased to hand over to Sandrine. Thank you.
Thank you, Iris, and good morning, good afternoon, everyone. As you know, my colleagues have just shared with you, we are truly pleased with this acquisition. This transaction has a very strong strategic fit. It also has financial merits. It's expected to be accretive to earnings as of 2023, and it supports sustainable long-term growth for UCB. It's a compelling value proposition for all stakeholders. Zogenix shareholders will receive $26 per share at closing, plus a CVR for a potential cash payment of as of December 2023 of Fintepla as an orphan medicine for treatment of Lennox-Gastaut syndrome. The total transaction, including the CVR, is valued at up to approximately $1.9 billion, which corresponds to EUR 1.7 billion. The board of directors of both companies have unanimously approved the transaction.
The closing of the transaction is subject to the tender of shares representing at least a majority of the total number of Zogenix outstanding shares, and the transaction is also subject to antitrust clearances and other customary conditions. We expect the closing by the end of Q2 this year. On the financing...
Oh, I'm sorry. We apparently lost, Sandrine. This is what happens in these unstable times. Sandrine, you're back. Can you hear us?
Sorry. It looks like I was cut, so I don't know where.
We lost you at the financing.
At the financing.
The funding.
Sorry about this. That's the home working. You know, sorry. On the financing, it will be financed by a combination of cash resources, available cash resources, and a new term loan of $800 million. The transaction is not subject to any financing condition. As you know, UCB has a strong balance sheet and is entering in this transaction based on the leverage level, which is below one time, having deleveraged since the Ra Pharma acquisition. Including this new loan, upon closing of the transaction, UCB will maintain strategic balance sheet flexibility. Regarding the financial impact, the acquisition will contribute and enhance UCB's revenue growth after closing.
FINTEPLA was launched in the US and Europe in 2020 and has significant commercial potential, which will strengthen the company's long-term growth, and the acquisition is expected to be accretive to UCB's earnings as of 2023. Let me now turn to the next and the last page of this presentation. Let me recap the key merits of the transaction, which provides a strong strategic fit with UCB. The two companies will combine forces and maximize the impact, leveraging the strength of their teams, their expertise, and their infrastructure. With Zogenix presence in rare disease, the transaction complements, strengthens UCB strategic position in epilepsy as our portfolio moves from classical seizure treatment to very specific disease population and more rare epilepsy treatments.
UCB will bring established global infrastructure and operations to support launches of FINTEPLA, help expand access to Zogenix products, and maximize the addressable patient population. The integration, which will take place after closing, is under preparation, and after closing, the acquisition will enhance UCB's top line growth and is expected to be accretive on earnings as of 2023. With this, let me hand over to Antje for opening Q&A session.
Thank you very much all, and thank you very much, Sandrine. We'd like to start the Q&A session. Those of you connected via Teams, if you please raise your hand, your virtual hand, and I will call your name. Please unmute yourself and turn on your camera. Those connected via the telephone line, please send me your questions via email, which is antje.witte@ucb.com, and I will have the privilege to ask the question on your behalf. The first question is coming from Jean-Jacques Le Fur from Bryan Garnier & Co, please.
Okay, sorry. Can you hear me?
We can hear you.
Thank you. Sorry for my camera. It doesn't work, so I prefer to be without it. I have three question, if I may. The first one is regarding the safety issues of the drug and the cardiac side effects. Is there any risk to see more and more cardiac side effects with increasing the number of patients to be treated? Because if I'm right, until now, it's about only 1,000 patients treated with FINTEPLA. So what could be the risk of that? And are the side effects reversible when stopping the drug? Second question is regarding cost synergies. Since you are now a well-established company in epilepsy, could we expect some cost synergies since Zogenix is spending about $260 million a year for R&D and SG&A?
You probably don't need these expenses due to your position in this disease area, sorry. Lastly, could we have more sort of update on the IP position, protection, data exclusivity, and so on? Many thanks.
Thank you. Sandrine, do you, Iris, sorry. Do you want to start with the REMS?
Yeah. Thank you. Very happy to do so. So, as I have stated, the mechanism of the potential cardiac valvulopathy and pulmonary arterial hypertension is really well understood. It's related to the serotonin agonist activity of the molecule, but it has only become visible at high doses, so 17 mg plus. In the current program for Dravet and LGS, the dose is limited to a maximum dose of 17 mg per day, dosing per se or per kilogram for the children. Neither in the clinical development program nor in the current post-marketing surveillance has there been any observation of valvulopathy in the heart or pulmonary arterial hypertension. From that perspective, well understood mechanism of action, the REMS works, provides the additional vigilance, and as expected, no evidence of safety issues there.
If anything would occur, yes, it would absolutely be reversible because again, it's related to the serotonergic mechanism of action. We should really applaud Zogenix for the courage to repurpose a very valid and well-known and effective molecule and develop it appropriately in Dravet and also in LGS. Thank you.
Thank you. Sandrine, do you want to continue with the synergies question, and then Charl would take the exclusivity?
Sure. So, you know, regarding the synergies, well, after closing, the combination of both companies would offer potential synergies and cost avoidance while, you know, reaching to people living with epilepsy. At this stage, we're not able to further comment on the integration or the commercial plan prior to closing.
Yeah, thank you for your question also, Jean-Jacques. The data exclusivity is until 2027, so that is the orphan indication. Just quickly, again, building on Sandrine's comments on synergies, I mean, clearly we see the value, of course, of reaching more patients. Top line growth and growing the full potential of FINTEPLA and all the indications will be our number one priority as a driver of value creation. Of course, synergies will also play an important contribution to that. I would just wanna position it as a growth asset for us.
Okay. Clear. Thank you very much.
Thank you. Thank you, Jean-Jacques. The next question is coming from Peter from Citi. Peter please go ahead.
Thank you. Can you hear me?
I can hear you, Peter.
Thank you for doing the call. Peter Verdult, Citi. three quick questions, please. Jean-Christophe Tellier, Zogenix publicly states a peak sales expectation of $1 billion. I know you don't like giving peak sales expectations, but can you at least characterize whether that's a view you share or given your leadership position in epilepsy is that something you feel that as a company you can do better than $1 billion? Secondly, for Charl van Zyl, on FINTEPLA, currently annualizing around $100 million, it does feel like the net additions are slowing. I don't know whether that's COVID or the dose cap or the high costs. When you look at the clinical data, the drug looks very differentiated in Dravet, perhaps less so in LGS.
Maybe you can talk about how you're thinking about the commercial potential in the different indications and bridging that gap from current levels to peak sales. Lastly, Sandrine, I'll try again on the previous question. Just can you give us any sense, I know you don't wanna go into the details, but should we be thinking modest accretion in terms of interpreting your comments for 2023? I suppose, you know, like Jean-Jacques, just trying to understand how much of that Zogenix cost base, you know, you can strip out. I realize you probably don't wanna go there, but at least just can you characterize whether it's modest or significant accretion that you're thinking about for 2023? Thank you.
Peter Verdult, thank you very much for your question. On the first one, first, just to make sure that I'm clear on that, it's not that I don't like to provide peak sales. I love to provide peak sales. The question is the moment and the when we can provide peak sales. I'm sorry to maybe create a bit of frustration here because I would like to test your patience and first we need to close this deal. Then we need to continue to see where the product is. Traditionally, after a few months of presence of the market, this is for us the moment where we would probably provide the peak sales.
You will have the ability to compare with what Zogenix had put in their plan before. Thank you.
Hi, Peter. Thank you for your question. Let me start with first, at least our insights into the launch performance. You know, what we see certainly is largely fitting the pieces of where they're going in terms of their stated peak sales. We know that during the pandemic there has been dampening of access, for example, to some of the clinics. Launching a new product like this during a pandemic environment is not optimal. That has probably slightly dampened the growth in early parts of the launch. Overall, we see just you know, the feedback from a key opinion leader perspective, the clinical profile, the efficacy profile is really you know, stellar in that sense. Very high commitment from physicians to use it there.
We feel confident with that sort of peak sales future potential that has also been stated by the company. I would say, just on the point of, you know, access to an extent, and in this case, we see really no restrictions at this point, especially in the U.S. market, of course, with patients having access to reimbursement. In the case of Dravet, of course, very strong profile and the clinical, you know, evidence supports that very strongly. In LGS, we know that there's a subpopulation that is more severe, that have severe seizures, as Iris had mentioned. Today also within the access environment in the U.S., you know, FINTEPLA will be in a third-step edit.
We factor that into our business model in the sense it will be first standard of care, then Epidyolex, and then FINTEPLA in the LGS population, where the population in that subset is really, you know, suffering from severe seizures. We see a very clear position in LGS based on the efficacy profile, but of course a subset of that population. Hopefully that answers your question.
You know, on the last one, I may create additional frustration. Sorry about this, but I'm sure it's not that difficult to have to close first and you know, come back and give you a better view on the expected accretion. We will work after closing on you know, the best integration plan with Zogenix team, and we'll be able to you know, to provide better guidance on accretion.
Thank you.
Thank you very much. The next question is coming from Jeroen Van den Bossche, and he's coming from KBC. Jeroen, please go ahead. Thank you. Jeroen, please unmute yourself.
Thank you, everybody, and congratulations on the potential acquisition. As I say, we also see it as a very good strategic fit. Thanks everybody else for the questions because they were also a little bit on the list before from mine. Maybe a question going forward. How would you see the split if you understand you can't really share the peak sales, but considering the patient population in Lennox-Gastaut syndrome seems higher than in Dravet. Can we expect that the sales split for this indication will be similarly you know affected or is the pricing going to be significantly different between the two indications? Can you share some light on that, the future?
Yeah. Thank you, Jeroen. I think just to be consistent there, we will, I think, have a more broader and deeper discussion on peak sales and, you know, that split between patient populations once we have a post-closing stage, and we can really go deeper into how we see the potential in each of those patient populations. Comfortable to come back to that at the right moment.
Okay. Maybe one follow-up question. The other asset in the pipeline, is it the idea to also go and commercialize that, as it seems to be somewhat of a different indication or, are you more going after the type of deal, like with Chiesi and Orphazyme there? If you can share, obviously, something around that or your ideas.
Yeah, I can start there. You know, again, I think our clear strategic fit, of course, is FINTEPLA and the indications and what it will bring to our epilepsy portfolio. We need a bit more time to assess the, you know, the pipeline in more detail, and we'll come back on choices we may think there. At this stage, our thesis of why is really built around the indications of FINTEPLA, and that's where we will focus.
Okay. Thank you very much and best of luck.
Thank you.
Thank you, Jeroen. The next question is coming from Ke Liu from Goldman Sachs, and he sent me an email. The first one is, can you talk to your confidence in potential competition concerns around this transaction, given UCB's dominance in the broader epilepsy field, and in particular, the ability to close by the end of the second , 2022? Second, how should we think about the incremental financial flexibility post this transaction for UCB in areas of strategic interest? Jean-Christophe, Charles, for the first one
Yeah. I'm happy to start on the antitrust. Of course, we have, you know, taken careful view of this, but, you know, I would just state very clearly that today in our portfolio, we have no indication for Dravet or Lennox-Gastaut in any of our assets. So it's really there is no overlap of indications. We see this very much as a separate solution for a separate patient population and feel therefore very confident on the clearance and the potential to clear this deal.
Yeah, I would agree. I would just refer to the first slide that Iris Löw-Friedrich mentioned in a sense, where you see the split in the current treatment of epilepsy, where you get 70% of the patients' population which are treated and controlled with certain treatment. We are looking at a subpart of the 30% who are refractory. This is really the subpart of this population that we are currently addressing potentially with FINTEPLA. I think that there is from an indication standpoint, from a focus standpoint, from the size of the populations and the definition of the population, from our perspective, it's a complement and an addition that give us confidence on the closing.
On the second question, Sandrine Dufour, on the financial balance sheet aspects, I'd like to highlight the fact that we maintain strategic balance sheet flexibility, including the loan upon closing. Before the transaction, we are entering this transaction on the leverage, which is at a level below 1 time. We have deleveraged since the Ra Pharma acquisition. The combination of this transaction on the balance sheet, we still maintain the strategic flexibility.
Thank you very much. The next question is also coming online via email. No, I did not make up this order. It's coming from Diana Nah from Berenberg. The first question is, in terms of the consensus sales ramp for FINTEPLA, consensus is looking for roughly $700 million by 2025. How realistic do you think the sales ramp is, in particular in context to the competitor product from Jazz? Second, with respect to the financing, how should we think about the split between cash versus a new term loan and the interest rate assumption?
Yes, thank you for that question, Diana. Here I would again emphasize that we would certainly post-closing come back to a more deeper discussion around consensus by 2025 and be very happy to go deeper into also the patient populations and how that is constructed. Stay tuned to that time frame, and we will come back in more detail on that.
All right. On your second question, Diana, upon closing, the purchase price will be financed out of this new $800 million term loan, and the rest is the available cash which is on our balance sheet. As for your question on the costs, you know, the new loan terms are in line with the Ra Pharma loan. Now, if I look at the average expected rate over five years and say from the five years, the average is at 2.25%. I'm very precise.
Thank you, Sandrine. The next question is coming from Ivan Stroganov. Please state your company name and unmute yourself, please. Ivan, can you hear us? Hello?
Hi. Ivan Stroganov, Truffle Capital. Just a question on this acquisition and maybe a broader strategy of UCB. Kind of historically, at least part of the investment community thought about the epilepsy franchise as more second priority for UCB. If we look at the pipeline, the expected revenues from other indications, from other franchises, been expected to be much higher than from epilepsy. I'm just curious, kind of beyond the Zogenix transactions, what type of activities in epilepsy should we expect from UCB, either on R&D front or on the acquisition. Would it be, again, as you mentioned in your slide, something in the unmet medical need, or maybe it would be in the broader epilepsy where with. Yeah. Thank you.
Jean-Christophe?
Yes. Thank you, Ivan, for the question. I think you have already a piece of answer in two components, right? One was what Charl has said with you, right? I mean, we always have been committed, and we will continue to be committed to be in a leading position in epilepsy. Now, the evolution of the pipeline is the one that I would like maybe to highlight to further answer your question. It's true that we have seen an evolution in research in epilepsy, right?
During the last maybe 20, 30 years, it was mainly symptomatic treatment to try to get, mainly through channel blockers, getting access to treatment that can, with chronic therapy, prevent seizures from happening on a regular basis in general epileptic population. Through this research, we have had great success ourselves. I mean, Keppra, VIMPAT, BRIVIACT are a few of them, for us and others. We are moving now towards a different focus, which is more towards specific subpopulations of epileptic patients, which are refractory patients today, meaning that the current standard of care, it's difficult to treat and very difficult to treat.
We are focusing more internally, and we will continue to look at potential external inorganic opportunity there to try to complement what we have and to try to focus on more disease-specific subpopulation, where we can provide more a disease type of modifications more than just symptomatic treatment. I would like you to continue to think about UCB in these terms, leadership in epilepsy and focusing on different type of patient populations moving forward. I think Zogenix, to that extent, is a great example and illustration of this evolution.
Thank you very much. The next question is coming from Charles Pitman from Redburn. Can you please talk a bit about the commercial efforts of UCB will adapt to promoting FINTEPLA, given its controlled use status? And how are you thinking about the hurdles to Zogenix sales outpacing consensus expectations? Is it just a matter of applying UCB's superior marketing power? Could you remind us of the key Zogenix catalyst that we should be watching out for both FINTEPLA and MT 1621. How are you thinking about the antitrust regulations? Have you had any early conversations with the regulators? I think there's a lot of challenges in it.
Thank you, Antje. On your question, Charles, on the sales perspective, of course, we have a global footprint in all the key markets, and we have very strong relationships on all levels, from tertiary centers to secondary, and in some cases, primary care coverage. We feel we have a very strong presence where patients with Dravet or LGS are presenting themselves. Of course, we will work very closely with our partners at Zogenix to collaborate and ensure that we continue to see this momentum that is there today in their launch to not be disrupted and continue that momentum going forward.
We feel, you know, in the mid- to mid-term that, you know, one sales organization that is really focused on delivering this entire portfolio based on the customer needs is how we would continue to evolve and build our leadership potential there. You know, we will. As we said, really, the focus remains on Dravet and LGS, and that is also an important next milestone, which is the LGS approval that we would expect in the U.S. and then in Europe that will follow later. Those that will be, I would say, important triggers.
When we look at the rest of the pipeline, as we said a bit earlier on the call, we will take our time post-closing to evaluate each of those options in the pipeline and come back with a more specific view or valuation of what we see in that pipeline. Today, the focus and the emphasis of the deal is very much on the indications that are either commercially now available or will be approved in the short -term in the market. I think I've covered all the questions, Antje. If there's anything else that I may have missed, let me know.
He also wanted to know a little bit more about the. He's trying, pushing his luck again on the antitrust question.
Yeah. No, I think we as we said we remain confident that there is no major obstacles in this Q2, Q3 time frame is when we believe we will get clearance. That's how we remain confident at this point.
Certainly. I have just reconfirmed, we expecting closing by the end of the second quarter of this year. Peter Verdult is asking another question because he has been prompted. Peter, I allow you to ask a second question. Please go ahead.
Thank you, Antje. This is on behalf of an investor on the call. They've asked me to put this question to you. Jean-Christophe, can you give any information about the background or process leading up to the transaction? Just give us a sense as to how competitive the process was or exclusive. I realize you can't go into the gory details, but if you could at least characterize the background and then the process, that'll be helpful. Thank you.
Well, I don't know how I can characterize this. What I can say is that we are very pleased to be in front of you today. The fact that we are in front of you today means that we have reached an agreement with unanimous support of the two boards. That has been our main objective and that's the situation we are in. Fact-based, this is the only thing that I can share with you. From what I have seen, from what I have known, I'm very pleased with the way we have engaged with Zogenix to reach this agreement, and very pleased for both of us where we are now.
Thank you.
Okay. I have another question from Vimal, from Bernstein, and he wants to go again into the price point topic. Given the significantly higher price point of FINTEPLA versus Epidiolex, how will UCB approach commercialization? Is there an efficacy angle you can point to that justifies a higher price point, particularly in LGS, given the headlines on efficacy are not too dissimilar and some of the secondary endpoints failed to reach statistical significance.
Thank you for that question. I would emphasize that, of course, we have also done our homework on pricing, and today we are very confident with the price levels that are there. The access is not denied to patients today, and there's a very clear protocol of how patients are being given access in a sense through a step edit process, as many would be familiar within the U.S. In that case, as we mentioned also with LGS, there's a third line positioning today in the access environment, a three-step edit process. Through that process, the reimbursement is guaranteed in a sense for these patients who really need the treatment, who have severe seizure manifestations. We see today no access restrictions.
Of course, we will also work with the associations and with the payers to ensure patient assistance where needed. From that perspective, we are very confident. With the current pricing assumptions that are there, right? That also have been set by the company, of course.
Yeah. Thank you very much. I think this is what I have on my list. I don't see a hand raised. If you want to ask a question on Teams, please raise your hand so we can unmute you. I have Jane Davis raised his hand or her hand. Sorry. Please go ahead.
Jane.
Can you hear? Yeah.
Yeah. I'm just wondering why this deal happened before LGS approval and if you feel that there's any risk to LGS approval, which happens later in the quarter. The second question is just if you can sort of give any commentary if this was just a meeting of the minds between the two companies or whether or not this was you know how competitive a process this was. Thanks very much.
Iris, did you want to comment on the LGS regulatory path?
Yeah. Based on the information that we have seen and, of course, what's in the public domain, there is currently no concern around the approval in the U.S. Of course, this is in the hands of FDA, not in our hands, so I can only speak to what you would expect in the regulatory process.
Just in case, as there has been some confusion among others, the CVR is linked to LGS approval as an orphan drug designation in Europe. It's not linked to the United States, just if there is some confusion. And then I have a last question. From Richard Parkes, BNP Paribas Exane. Can you talk about stay time on drug in trials and in the market and tolerability? Obviously, the ability to stay on drug for a long time has been one of the main drivers for VIMPAT success. So generics shares sold off aggressively when the LGS data reported, given the data was viewed as underwhelming. Can you help us understand what the market got wrong there? And last but not least, is base case that generics launch immediately post orphan drug exclusivity?
I note that there are patents well beyond. I was just wondering about your confidence they will delay generic launches further. Iris, could you start?
Maybe. Yeah, if I may provide a physician's perspective, right? On LGS, first of all, these patients suffer heavily, and these patients need medication, and these patients are not controlled with what is available for them, so new options are necessary. The overall efficacy on the primary endpoint and also on the secondary endpoints in the LGS trial is on par with the other approved medicines in that space, right? What we have seen was a 20% superiority on drug seizures over placebo, and that's very much in line with what has been seen with other medicines as well. Charles mentioned it, and I try to indicate it as well.
Generalized tonic-clonic seizures are a very important seizure in these patients and are also the seizures that are associated more with sudden deaths of epilepsy. There is very promising, compelling results on this subpopulation in the LGS study. Last but not least, the LGS study included patients, about 30%, who were failures on cannabidiol, so particular need where one of the more recent, approved medicines did not provide a satisfactory treatment effect. Just wanted to provide a physician context around the LGS results, because I really believe that this will be a much needed addition to the so quite limited treatment armamentarium of the pediatric epileptologist.
Thank you very much. Charles or Jean-Christophe Tellier, you want to follow on the orphan drug exclusivity piece?
I can just again comment that what we know today is 2027 as the period of exclusivity, and that's also how we have, of course, assumed that in our valuation. It's too early to really comment if there's any potential beyond that. I think we would leave it at 2027.
Yeah. Perfect. Nothing to add. Yes, it's exactly that.
Thank you very much, dear all. We have come to the end of the call and to the end of the question list. Thank you very much for your attendance. For any further questions, you know where to find the UCB Investor Relations team. Thank you very much. Bye-bye. Take care.
Thank you. Bye-bye.