Before starting, I'd like to remind everyone that we'll be discussing forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those discussed today. There are factors that could cause our actual results to differ materially, which are discussed in the most recent Form 20-F and in our other SEC filings. Please also refer to the important notice on page two of the presentation. Now, please let me introduce today's presenters and panel. Christophe Weber, President and CEO. Andrew Plump, President of R&D. Costa Saroukos, Chief Financial Officer. Ramona Sequeira, President, US Business Unit and Global Portfolio Commercialization. First, Christophe will give you a presentation. After that, we will have a question and answer session. Now I'd like to begin.
Thank you very much. It's a great pleasure to be with you. I wish we could be in the same meeting rooms. That would have avoided the technical issue. But the pandemic is still there with us, and I think it's a reminder that developing new treatments for any disease is so important for the society. I will jump directly to slide number three. I'll try to save a bit of time because of that delay. You know our vision. Our vision is to discover and deliver life-transforming treatment, guided by our commitment to patients, our people on the planet. This is a purpose-led and value-based approach which drive all our action and decision.
As we look into the future, we see a very significant potential in data and digital and technology. Technology will revolutionize our business and create better experience and outcome for patients, accelerate the discovery, development, and delivery of life-transforming treatment, and it will transform the way we work. Our goal is to continue to grow Takeda into the most trusted, science-driven, data-enabled biopharmaceutical company. To slide four, just explain where we are at the present time. Our business transformation accelerated through the acquisition of Shire has provided us with the runway to scale our ambitions. As you will see in the next slide, and it's not news for you, we remain headquartered in Japan. We maintain a global hub in Boston.
We have a presence in 80 countries and regions, 31 manufacturing sites globally, three research centers in Japan and the United States. The last fiscal year, we had a net revenue of approximately $29 billion with a regional breakdown of sales, which is broadly in line with the industry average. Our key business areas of GI, rare disease, plasma-derived therapies, oncology, and neuroscience represent a balanced and diverse portfolio, making important contributions to our top line. Our global scale helps us to drive a strong portfolio of 14 Global Brands to generate steady organic top-line performance, while also driving competitive margins and strong cash flow to fuel future innovation. Recent product launches, such as EXKIVITY and LIVTENCITY, inject even more growth momentum, adding to the potential of our growing global portfolio. One of our top priorities has been to develop our pipeline.
We have an exciting and diverse pipeline with approximately 14 new molecules, with the potential to address significant unmet needs. As an R&D-driven company with a high bar for innovation, we know that not every program will succeed. However, the depth of our pipeline gives us confidence that our R&D engine will continue to produce novel medicines at a level that will help support the long-term growth of the company. Having gained regulatory approval and launched two new products in the last month of 2021, we are even more confident today that the strength of our commercial execution, combined with the potential of our pipeline, will help to fuel our long-term revenue growth. On slide five, we highlight the impact of the business transformation, including the integration of Shire, which allows us to deliver our financial commitment.
This includes top-line acceleration with underlying revenue growth expected to be in the mid-single digits this fiscal year, driven by our 14 Global Brands, as well as our new product launches. In addition to growing the top line, Takeda continues to focus on delivering a competitive underlying core operating profit margin. Our strong margin will continue to drive abundant cash flow, which allows us to invest in our growth drivers while also paying down our debt towards our target of low 2s net debt to adjusted EBITDA by the end of fiscal year 2023. Finally, we have a well-established dividend policy and recently announced our first share buyback in 13 years, underscoring our confidence in our business strategy and commitment to delivering value to shareholders.
Moving to the next slide, I'd like to focus on our 14 Global Brands, which I expect it to continue to drive our growth expectation over the medium term. This brand generated a total of $11 billion in the last fiscal year, and are on track to meet our underlying revenue growth forecast of 14/16 for FY 2021. Our growth forecast of 14%-16% for FY 2021. It means that the potential for annual incremental revenue of approximately $1.5 billion driven by this 14 Global Brands. We expect this momentum to continue into the medium term. We expect continued growth momentum through increased market penetration in launch countries and geographic expansion in Japan and emerging markets, particularly China. To briefly highlight some of our 14 Global Brands, I will mention TAKHZYRO, which is as a leading position in hereditary angioedema.
I will mention our IG portfolio, immunoglobulin portfolio, both IV and subcutaneous formulation. This product generated revenue of $3 billion last fiscal year, and are expected to grow in the medium term. I will also mention, of course, ENTYVIO, our biggest product, which doubled revenue of almost $4 billion last fiscal year. It is constantly growing because we are constantly gaining market share in countries where we are already launched, and we are also expanding geographically and launching ENTYVIO in many countries. Regarding ENTYVIO, next slide on slide seven, I would like to take some time to walk you through how we are thinking now about the timeline for potential biosimilar entry for ENTYVIO.
Until now, the base case we have been using regarding biosimilar entry timing has been the most conservative scenario coinciding with the expiration of ENTYVIO data exclusivity, which occurs at the earliest in May 2024 in Europe and May 2026 in the U.S. When we look at the analyst consensus for ENTYVIO sales erosion, this also appears to be the assumption that most, but not all, analysts have taken. However, we are now in 2022, and being in 2022, two-four years only before data exclusivity expiry, we now believe that these previous scenarios for biosimilar entry should be revisited. Why?
First, at this point, we are not aware of ENTYVIO biosimilar in clinical development, and our best estimate is that it will take at least four-five years for biosimilar to go through all the clinical studies, generate the relevant data, and undergo regulatory review for approval. We believe that any biosimilar entering the clinic now will be unlikely to complete the clinical development timeline before the end of the data exclusivity period. Secondly, from an intellectual property perspective, as we have mentioned previously, Takeda has granted patent that cover various aspect of ENTYVIO, including formulation, dosing regimen, and process for manufacturing, which are expected to expire in 2032 in the U.S. Therefore, any biosimilar that seeks to launch prior to 2032 will need to address potential infringement and/or the validity of all relevant patents.
Thirdly, as a reminder, ENTYVIO is only indicated in ulcerative colitis and Crohn's disease, so any biosimilar will need to conduct studies in at least one of these disease areas. This is unlike biosimilar for anti-TNF, for example, which are approved in a broader range of indication and therefore give biosimilar various potential entry points. For all these reasons, we believe it is highly unlikely we will see biosimilar launch in the U.S. or Europe upon expiration of data exclusivity. Now moving to the next slide. Let's take a look at the new product launches and what this means for our top line over the next five years. With the recent approval of both EXKIVITY and LIVTENCITY, I've demonstrated that we have a portfolio of new products coming to market that are well-positioned to drive additional growth.
Both EXKIVITY and LIVTENCITY are highly innovative products and are responding to a very high unmet medical needs, and we are really looking forward to launch these two products first in the U.S. and then in many countries across the world. This is a blueprint for our pipeline strategy. We set a high bar for innovation to bring forward truly transformative treatments for patients who have significant unmet needs. As for the strong growth of our global brands, we believe there is a potential for significant incremental revenue growth out to FY 2025, as outlined on slide nine. With the 14 Global Brands and new launches such as EXKIVITY and LIVTENCITY expected to deliver approximately $9 billion of incremental revenue, double what we expect to lose from the loss of exclusivity of VYVANSE, VELCADE, and AZILVA, and the decline of other in-line products such as our hemophilia franchise.
We believe that the market underestimate our ability to grow through some of our near-term headwinds, but I want to emphasize that Takeda is well positioned to deliver top-line growth in the next five years with even more confidence now that we do not expect ENTYVIO biosimilar launches during this time frame. In addition to top line, we'll continue to focus on our margins and strive to deliver underlying corporate profit margin in the low to mid-30s range. In the previous slide, we laid out growth expectation until fiscal year 2025. We truly believe that Takeda is well-positioned to continue delivering growth beyond fiscal year 2025 and well into the next decade. Looking now at slide 10, it is important to recognize the continued growth potential of our existing portfolio. For example, our IG franchise, TAKHZYRO .
We believe that that will be combined with the launch of new product, will be more than offsetting the major US losses of exclusivity in the last half of this decade, namely TRINTELLIX in 2026 and ENTYVIO in 2029. I want to emphasize that we cannot depend upon ENTYVIO alone to support the company over the long term. As I mentioned previously, we have built a deep and highly innovative pipeline through our R&D transformation, with approximately 40 new molecular entities in clinical stage, several of which have sales potential over $1 billion. On the next slide, you will see that our global R&D strategy is working. We just want to reinforce this global R&D strategy here.
We continue to advance highly innovative, life-transforming medicine in our core therapeutic areas of oncology, rare genetic and hematology disease, neuroscience and gastroenterology, with strategic investments in our investment in plasma-derived therapy and vaccines. Our RMD strategy is not only to be therapy area-focused, it's also about a robust partnership model, which is a key driver to our success. Our world-class internal labs are partnering to access cutting-edge science wherever it originates. You will have seen, for example, that we just announced the acquisition of Adaptate Biotherapeutics to add a novel antibody-based gamma delta T-cell engager platform to Takeda's immuno-oncology portfolio. One third of our late-stage pipeline has received Breakthrough Therapy Designation, a true testament to our innovation and focus on developing transformational therapies where there is significant unmet need.
Approximately 50% of the pipeline has orphan drug designation or orphan potential in at least one indication. We continue to make significant investment to grow our expertise and capabilities in cell therapy, gene therapy, and data science, and overall to progress our pipeline. On the next slide, you actually will see that we are building one of the most modality-diverse pipeline in the industry. This is another part of the transformation that we did in the last few years. We are focused by therapy area, but at the same time, we are diversifying our activities across modalities in order to find the innovation and have this ability to leverage these modalities to deliver innovation in the therapy areas where we are active. This was only possible due to the total redesign of our R&D organization in the last few years.
On the next slide, you will see that our R&D strategy is working. We have a pipeline which is beginning to deliver on our ambitious aspiration. I mentioned earlier the recent FDA approval of EXKIVITY and ENTYVIO in the U.S. 90% of our pipeline didn't exist six years ago. Takeda R&D engine is advancing an ambitious stream of next-generation therapies. These programs are focused on providing transformative treatment for targeted population with high unmet need across our core therapeutic areas. I will not go through the entire pipeline, but I will mention a handful of programs which are truly transformative for the disease that they will treat. I will mention our dengue vaccines, TAK-755, which is the only ADAMTS13 replacement therapy in clinical development.
I will mention our oncology program, Modakafusp Alfa, Subasumstat, for example, which have the potential to be truly innovative. In GI, we mentioned TAK-999, our collaboration with Arrowhead in alpha-1 antitrypsin deficiency liver disease. At the same time, you know, we have some setback. It's very clear. We received a complete response letter from the FDA in response to the new drug application for TAK-721. We are assessing the detail of this CRL of this complete response later. Moving forward, we see a great potential to further enrich our pipeline. We are excited by future potential partnership. We continue to progress. We don't rely only on, you know, five molecules. We have 40 in development, and we will continue to focus on developing our innovative pipeline.
On the next slide, it's very clear that the commercial potential of this pipeline is very, very significant. If you look at the 10 programs which are in phase III or pivotal stage, these 10 programs are having an aggregate peak potential sales of more than $10 billion, with an, on a risk-adjusted basis, more than $5 billion. On these 10 programs, EXKIVITY and ENTYVIO have already been approved in the U.S., with further geographic expansion to come. Another asset with potential approval this fiscal year is TAK-019, the Novavax COVID-19 vaccine candidate that Takeda will manufacture and distribute in Japan subject to license and approval. In fiscal year 2022, we anticipate the first approval for TAK-003, our dengue vaccine candidate.
If I move up the list, TAK-755 and TAK-861 could obtain their first approval in 2023, with TAK-611 following in fiscal year 2024. Finally, three of our wave two programs are starting their phase III or pivotal trial this year or next year, and we can expect potential approval path in fiscal year 2025 and beyond. On the next slide, we can see that there is more to come as we continue to de-risk several of our earlier stage programs. On slide 15, what you see is that we have five high potential molecules that will have important proof of concept readout in the coming two years, including our longer-lasting oral orexin agonist, TAK-861, and first-in-class cancer therapy, Subasumstat.
These are just the first of many wave two molecule of a rich and transformative early stage pipeline being continuously filled through partnership and our own powerful research engine. I want to underscore on this slide the importance of having built an innovative R&D engine that will continue to generate new opportunities going forward. A year ago, I presented a slide showing a wave one pipeline with $10 billion of potential peak sales. Our pipeline is dynamic in nature, and we follow the science. Some of our programs have faced unexpected challenges, but we are encouraged by strong early data in programs like Modakafusp alfa , and we have Mezagitamab, TAK-999, and pabinafusp alfa to help boost the mid-stage pipeline.
I can say that with a very high level of confidence that as we turn over new cards with each new data readout, the value of our pivotal stage pipeline will continue to increase. Don't forget, of course, our oncology franchise. While we are not including TAK-994 in this calculation, we still have multiple therapies in development. If TAK-861, TAK-925, or other programs come through development, we still see significant commercial potential. We expect to update the market on our plan for the franchise later this year. Finally, to close out on slide 16, our transformation continues to bring Takeda's future into focus, and will help to deliver tangible, sustainable growth.
In 2014, we set out on a journey to accelerate our globalization and to reinvent Takeda into a truly value-based, R&D-driven global company positioned for long-term business growth. We have proven that we can deliver on this promise. The Shire acquisition provided competitive scale. Having completed the integration very successfully, we are now in a position to deliver sustainable top-line growth, maintain competitive margin, and generate strong cash flow into the long term. I attribute much of our success to our amazing people. I am proud of the 50,000 dedicated and patient-focused Takeda colleagues that embody our values and work tirelessly to support our mission. They will help us build a dynamic future. Looking ahead, our growth strategy is on track.
As I mentioned earlier, the growth of our 14 Global Brands is expected to offset the loss of exclusivity headwinds to 2025, with further growth expected beyond. These factors reinforce our target to deliver underlying core operating profit margin in the low- to mid-30s% range. In addition, our innovative pipeline is expected to deliver accelerating contribution to the top line through the decade. We feel extremely confident about the path we are on. We are taking on big challenges that require a new way of thinking, especially by leveraging data and technology. We are focusing on building a diverse and highly innovative pipeline that will ensure that we continue to grow into the future. That brings us back to the vision that drives us, to discover and deliver life-transforming treatments guided by our commitment to patients, our people, and the planet. Thank you very much.
Thank you. Now we'd like to take questions. Please click hand raiser button of the Zoom, and we'd like to guide you one by one. As I mentioned earlier, please use the language that you selected in your question. If you chose off of the translation button, then you may use either English or Japanese. Now, if you have any questions, please raise your hand. Thank you. First is Mr. Yamaguchi over Citi Securities. Please start asking questions.
This is Yamaguchi from Citi.
Yes, we can hear you.
Great. Thank you. Happy New Year, all. First, two quick questions. The first question is regarding ENTYVIO. You slightly changed the guidance, but the kind of incremental new information regarding ENTYVIO biosimilar entry is the fact that we are getting into the new year. That's why it takes four-five years. Reality speaking, it takes. It won't be able to join, the biosimilar won't be able to approval for the next four-five years. Is that the right way to understand the situation? In other words, if they start next year excluding litigations, you are not. It will be launched in four or five down the road. In that sense, you are not really guiding, there's no biosimilar up until 2032. That's the first question.
Now, I will go to the second question as well. Second question is you mentioned underlying revenue growth of fiscal year 2021 guidance is a mid-single digit. This is the so-called underlying revenue growth. But at the same time, sometimes there is another non-underlying factors impacting core and full numbers. Can you give me some plus and minus to adjust from this underlying revenue growth to see more in the core of revenue growth, which is the more numbers people can look at it? Thank you. Two quick questions.
Thank you, Yamaguchi San. This is Christophe. I'll cover ENTYVIO and Costa perhaps will cover the second part of the question on the revenue reconciliation. You know, on ENTYVIO, we have been monitoring the situation for a while. We are in 2022 now. It's pretty clear that time is running short to have any biosimilar ready to launch, let's focus in the US in 2026, for example. There might be many different reasons as I outline for why biosimilar companies are not seeming very active. We should, you know, ask them. I mean, you should ask them if you want. We cannot speculate too much. There are many reasons. One is that, you know, it's developing an IVD product.
Whether it is a biosimilar or another product is complicated. It takes time. Clinical trials are difficult to do. The other reason could be that the intellectual property situation is complex. You know, it is very unlikely that a biosimilar could launch without some litigation. There are many reasons. When should we assume a biosimilar could be launched? It's very difficult to answer that question right now anymore. For sure the scenario that we use until now, May 2024 and May 2026 in the U.S., is not possible anymore. We shouldn't think it should be the scenario that we should use.
Now, you know, should we assume 2032 because this is when our, you know, key patents are expiring, we cannot neither predict that. We shouldn't speculate on possible litigation outcome. That's really the situation.
Thank you.
I can answer the second. Thank you, Yamaguchi San, for your question. As you rightfully said, we have two, the differences in underlying revenue growth that takes out the impact of divestitures and FX. And that's growing mid-single digit. When you look at core revenue growth for this fiscal year, the growth will be low single digit. They're the two variances for fiscal year 2021.
Oh, I understand. Low single digits. Okay. Rather than mid-single digit.
Low single digit.
Okay. Thank you. Thanks.
Thank you very much, Yamaguchi-san, for your question. We'd like to move on to the next question, Mr. Muraoka from J.P. Morgan Securities. Thank you. Thank you very much.
Thank you for taking my question. I have two question. My question is related, Yamaguchi-san . First question about Entyvio LOE. I'd like to know how you plan to use the profits from the extension of Entyvio LOE. Also I'd like to know if the rate of R&D investment or capital allocation in next two or three years will change in anticipation of this. This is the first question. The second question is about TAK-861. On the 15th slide, regarding TAK-861, you mentioned that POC will be obtained for NT1 in phase II trial during fiscal year 2022. Previously you said that the result of the phase I trial would be available using this during fiscal year 2022.
Could you please explain regarding the schedule of phase I and phase II trials for 861? Especially about start timing and data read out timing of 861. That's it.
Thank you for the question. Andy will cover 861. You know, of course ENTYVIO is very material to Takeda. And this new situation will generate significant upside for Takeda. Also because we have to revise ENTYVIO peak sales projection. We are not doing it today. This is something we have to do in the future because you know, our previous peak sales prediction was assuming biosimilar entry in 2024 and then 2026 in the US, no more. So our peak sales will be much higher than that. Having said that, it doesn't change our overall strategy. It doesn't change our overall strategy to focus on delivering our pipeline, to grow our top line, to focus on deleveraging, to focus on shareholder return.
Overall, it will help us to deliver our strategy further, but don't change our overall capital allocation strategy.
Okay.
Christophe, if I may, on TAK-861, Muraoka-san. Thank you very much for the question. We're in the process of evaluating the TAK-994 phase IIb dataset. We continue to develop a deeper understanding of the mechanism of the hepatotoxicity of TAK-994. As we mentioned at the end of last year, we continue to accelerate TAK-861 in its phase I program. We don't have specific targets for when we'd be disclosing additional information, but for sure in the early part of 2022, we'll have more information on 861 in terms of its effects in sleep deprived healthy volunteers and in narcolepsy type one patients. We should in FY 2022 have a planned path forward for 861.
Okay, thank you.
Thank you. Next, question is from Mr. Muraoka, Morgan Stanley.
Hello, this is Muraoka, Morgan Stanley. Can you hear me okay?
Yes, we can.
Now allow me to ask you a question in Japanese. About R&D updates. In your presentation in late 2022, I heard that you will give us an update of R&D situations. What is the exact timing of the next update? And as a clinical data update, what concretely the disclosure is? Is the one that you're expecting to announce in late 2022? The revenues will be growing up until FY 2022. We understand that. Regarding the core operating profit, in FY 2023, there will be a decline. I think majority of the people consider it is unavoidable.
Do you have any ideas on this and any countermeasures that you may plan to take, please? Thank you.
Thank you very much for the question, Muraoka-san. For the R&D day, Chris can confirm that we don't have a date yet for when we'll do an R&D update. We'll continue to do some update every quarter, but a specific R&D day, no date yet fixed. Is it correct, Chris?
Yeah, that's correct, Christophe. It's Costa here. We are planning later in the fiscal year 2022. The specific date, we'll let you know once it's confirmed.
Regarding the second part of your question, Muraoka-san, I think that there is a... We believe that our 14 Global Brands growth momentum is strong enough to offset in the next four years to offset the decline of products like Vyvanse, VELCADE and AZILVA. I think that's a disconnect between our perception of the business and what you just stated, for example, that decline is unavoidable. We don't believe that. Every year, the 14 Global Brands grow by $1.5 billion, JPY 150 billion roughly. And Vyvanse will not disappear in 12 months. It's fast, but it's not happening in 12 months. It depends when generics exactly are launched on a given fiscal year.
None of the 14 Global Brands is facing generics in the next four years. ENTYVIO was always a threat, but no more. It cannot happen anymore before 2026. That's why we want to show in slide nine. I will just reinforce that slide. We don't believe that our growth will be slowed down of course by Vyvanse, VELCADE and AZILVA loss of exclusivity. We believe that we have enough growth momentum through especially our 14 Global Brands to offset this loss. I think there might be a misunderstanding in the past about what the 14 Global Brands were. Vyvanse, for example, is not a 14 Global Brand. It's not part of the 14 Global Brands.
AZILVA neither, and VELCADE too, you know. I think that's really important to have this dynamic. We are seeing the 14 Global Brands growth accelerating very significantly because of the globalization of the 14 Global Brands. Look at the business in China now that we are expanding, which China is launching pretty much every 14 Global Brands will be launched in China sooner or later. That’s also what is fueling our growth of the 14 Global Brands.
I can just add one comment as well, just to reinforce Christophe's point, that our underlying operating profit margin is still going to be within the targets that we've committed to, low-30s% to mid-30s% range. Despite the loss of exclusivity of Vyvanse, our 14 Global Brands acceleration of the growth there, the management of our OpEx will help us maintain this underlying operating profit margin. It's really important to acknowledge that. Our 14 Global Brands do have a pretty greater margin overall compared to the total company-wide margin as well. Something to consider. Of course, every quarter that we provide you our results, you'll see the deliverable of what the 14 Global Brands are doing from a strategic point of view. Thank you very much for your question.
Thank you very much. We'd like to move on to the next question from Credit Suisse Securities, Mr. Sakai, please.
This is Sakai from Credit Suisse. Can you hear me?
Yes, we can hear you. Thank you.
Good morning or good evening, and happy new year. Just a couple of housekeeping questions. The first one, Novavax vaccine, can you give us some update? I know you filed in Japan, but I think that you have a global supply contract with Novavax for vaccine. Obviously our COVID situation is changing so rapidly. That probably makes some change on course of the vaccine use in due course. That's my first question. Second question. Since Ramona is here, I just wanna ask U.S. market situation right now. Now, generally speaking, what about the pricing situation, pricing strategy in the U.S.? Everyone expecting kind of deflation or flat price going forward. Now we're not gonna inflate the price anymore.
That, I think, is the maybe a message, I guess, from the federal government. What do you think about the future going forward? Two questions. Thank you.
Thank you, Sakai-san, and happy new year to all of you. Looks like the year has started a long time ago already, you know. I'll let Ramona develop the second part of the question because I guess it could take a long time, and then I go on the vaccines.
Okay. I will jump right in on that. Thank you for that question. I'm just gonna add, since you asked about the U.S. market, I know we just talked about our global brands, which are growing through market penetration, increased geographic launches. I did wanna say that EXKIVITY and LIVTENCITY have just been launched in the U.S. market too, and are doing, you know, early days. We're not ready to disclose much, but, you know, very, very encouraged by the results that we're seeing there. On the drug pricing situation, if you look at Takeda specifically, last year, we disclosed on our website our list and net price increases. Last year, our list price increase was 3.4% across our portfolio. Our net price increase was 1.9% across our portfolio.
For Takeda, for the past number of years, our list price increases have been in a, you know, low- to mid-single digits. Our net price increases have been largely below inflation. You know, certainly one of the aspects of drug pricing legislation in the U.S. is looking at penalties for inflationary price increases that are greater than inflation. We have been behaving in that way for a number of years already. Don't see a, you know, material impact to Takeda from that type of situation. The other pieces of the drug price situation in the U.S., one is redesigning Part D. That's something that we probably need to know a little bit more about because the devil's in the details, on that.
Certainly lowering out-of-pocket costs, pocket costs is one piece of that, and that is important, and that'll be very helpful for patients. The last piece is negotiation, and that one, there's still some challenges with exactly how that's gonna work, and what we're gonna see from that if that goes through. You know, as with anything in the U.S., drug pricing is so complicated, it's very difficult to predict exactly how things are gonna play out. Takeda certainly has been very responsible in our pricing in the U.S. and intends to continue to do so regardless of what the legislation comes back as. Thank you.
Thank you.
Thank you, Ramona. On Novavax, we are a long-term partner with Novavax because we are, you know, preparing the launch in Japan, but we are also done a full technology transfer. We are investing into manufacturing capacity. This capacity could be used beyond Japan depending on how much the Japanese government order the product. But more importantly as well, Novavax is adding in the vaccines overall offer and arsenal another technology because most used vaccines today are mRNA, the DNA vaccines. There is a need for protein and preventive vaccines, which is Novavax vaccines. I think that that's why we are very excited about it, but also because the data looks very strong, the efficacy data.
It's too early to speculate how Novavax vaccines will be used in terms of the booster strategy or primary vaccination. We are very much looking forward to launching the product in Japan and potentially be a partner of Novavax in other countries as we are building this extra manufacturing capacity. Thank you very much.
Thank you very much. In the interest of time, the next question is, the final question. Next is Hashiguchi-san of Daiwa Securities, please.
Thank you very much. This is Hashiguchi, Daiwa Securities. I have two questions. My first question is that, in FY 2025, JPY 9 billion data global product and new product growth is expected. However, there seems to be a gap between your perception and the market, and, which one has the greater gap, or the market is underestimating more in any particular product or molecules. The second question is, the recent topic. Eohilia, why you didn't get an approval. About one year ago, in wave one pipeline deep dive, you announced a very strong confidence on this. Dr.
Plump and Weber, since you joined Takeda, you filed some of those to FDA, like ENTYVIO SC, which was not granted, and also there are some other programs that delayed in approval. When you make a plan of R&D and also execute those R&D plan, if there are any issues or problems, you see, what are those issues in your view, please?
Andrew, could you start with the second part of the question?
Sure. Well, you know, firstly, we all understand that whenever we do anything in R&D in our business, we assume some level of risk. We try in our communications to highlight what we perceive as the risks in our program as we carry them forward, and we try to be very transparent and open with you in terms of what we think our probabilities of success are. If I go specifically to Eohilia, I'll say that when we submitted Eohilia, we actually were quite confident in an approval. This was a high unmet medical need, eosinophilic esophagitis, with no proven therapies. We had a very strong set of results from the induction portion of our phase III study.
We shared with you and with the agency that we had run a second study, a maintenance study, that was not large enough because of the study design to show significance, but it trended towards very meaningful clinical benefits for patients. It was a program that had Breakthrough Therapy Designation based on phase II data that were generally reproduced in phase III. So we were surprised a bit by the FDA's reaction. The fact that the FDA didn't give us a CRL at the time of the PDUFA date, but waited six months as it went back and forth with us on an information request was quite a big statement. The FDA has a deal with the pharmaceutical industry to make greater than 90% of its PDUFA dates, so it's a big deal when it misses a PDUFA date.
We were encouraged by the back-and-forth dialogue with FDA, but in the end, they decided that it was the file wasn't worthy of approval as is, and that we would require another phase III study. You know, that we could speculate why things happen. We'll share with you more details once we make a final decision as to what our path forward is. Certainly the competitive landscape for eosinophilic esophagitis has advanced. That's good news for patients, and that may have had some bearing on the agency's decision. Right now, Christophe mentioned in his presentation, we're digesting and working through the details of the CRL, and we'll have in the very near future plans for what our path forward is.
You know, I would add one thing. It's important to have in mind that we are focusing on life-transforming treatment medicines. We are trying to solve problems, medical problems, which are very significant. Otherwise, the unmet medical need will not be high, right? I mean, we are not looking at also me too or being the third in class, fifth, that what we used to do no more. When you have a strategy like that, expect some setback, but focus on the win. You know, what is important is to have enough shot on goals. That's why we insist on the 14 new product in development because if we would have five and three fail, then it's a big problem.
If you have 14, of course you need to have the sense of urgency and to make sure that the pipeline is progressing on time. You know, you have enough momentum, and you can grow your growth. That's why, you know, we are showing a bit differently our pipeline because at the same time we had the setback of TAK-994, which is very, very significant. At the same time, we had very good news, very encouraging news on mobocertinib. And mobocertinib is a potentially multi-billion product. No doubt about that. We need to see what that molecule can deliver, but this is how things are evolving. That's what happens when you develop a life-transforming medicine.
On your first part of the question, I think the disconnection happened in the assessment of the 14 Global Brands. That's why I encourage you to look at Slide six. Because in 2019, the 14 Global Brands represent 34% of the total Takeda business. In 2021, 44%. It's growing in the mid-teens. I think this is where the disconnect. It's not one product, but it's the overall materiality of the 14 Global Brands and the growth momentum that they can provide. None of these 14 Global Brands are facing generics in the next four years. None of them. I think that's really where there is the disconnect. The headwinds are well-known. We all agree with them.
I think what is important is the tailwind and the growth driver that we have. This 14 Global Brands will represent more than half of our business, you know, very soon, considering the growth momentum that they have. I think this is where there is the overall disconnect. Again, I think what is important is to look at the big picture, not. There will be some quarter where we'll, you know, get hit big time when Vyvanse will lose their exclusivity. But what is important is to look at the overall dynamic, and, you know, basically our growth drivers. Value generation is twice bigger, two times bigger than the headwinds decline in the next four years. That's what matters.
Thank you very much. We are very sorry that we have gone over the scheduled time. It is time to close this management call meeting. Thank you so much for joining us despite very early in the morning here in Tokyo. I hope to have your support throughout the new year.