Q1 2023 Takeda Pharmaceutical Co Ltd Earnings Call

Good evening, everyone.

You know some are homebound Lotte hi al.

Good morning.

If I Miss it.

Thank you very much for joining us for the first half of the 2022 Decision Webinar on the Takeda Pharmaceutical Industry.

Christophe Weber: And we believe, that will really help patients with their treatment.

When did you I always look I've seen a got a good ice cream called you and I'll send you an union so that just you're having to give some maybe non equal sounds like that to keep our company. How do you get the other thing I said.

Ayako Iwamura: My name is Ayako Iwamura, and I will be your moderator today.

Christophe Weber: And we don't have the indication of CIDP in the US.

But ask you about the Sky yachts for me unless I got at times, though not you omri up with almost a must have.

Thank you for joining us.

Christophe Weber: We don't have it for our IV as well as for our subcube.

Hopefully, it's going I just miss it.

First, I would like to introduce the language settings.

Christophe Weber: We believe that nevertheless, our products are used, but we never had the indication.

Most of the jingle sit then you'd see that and of course, you've got all sorts of data that you must feel it.

For those who wish to listen to this call in English, please click the language selector button at the bottom of the Zoom window and then select English.

Zooming in on a sunny Eaglebank goggles I'm I sit.

The whole World Alkene 90 day I got a lot in your home golf.

Yeah, well don't get gain I thought I caught the eye angle.

What are you seeing that in wholesale kicking in or anything you've got a lot of any state or geeky that I gave I thought the ones you must feel it.

For those who wish to who wish to listen to this call and in English. Please click the language selector button at the bottom of that little window, and then select English.

本日のカンファレンスコールでは、米国の1995年、民事証券訴訟改革法で規定される将来に関する見通し情報を議論させていただくことを皆様にお伝え申し上げます。 実際の結果は、本日議論される結果と大きく異なる場合がございます。 実際の結果を大きく異なるものにする可能性のある要因については、最新のフォーム20F及びその他のSECへの提出書類に記載しております。 また、本日のプレゼンテーション資料の2ページの重要な注意事項も併せてご確認をお願い申し上げます。

Yeah.

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それでは本日のプレゼンテーションに移りたいと思います。 本日のプレゼンテーションですが、社長、CEOのクリストフ・ウェーバー、R&Dプレジデントのアンディ・プランプ、チーフ・フィナンシャルオフィサーのコスタ・サロコスより実施させていただきます。 その後、皆様から質疑応答の時間を設けて質問を頂戴したいと思っております。

But I do once.

As long as it's not present, there so and you see that I don't want to mess it.

Once it's in the presentation on this guy shut door, she or locally or whoever.

Otto onto the president, though not on deep and.

He was he knows it all.

So not all stuff that Augusta Jody just yourself the data that you must have.

So I know what you mean us on what got us to the automotive goal and we'll get that's the mantra that I say don't want dirty muscle.

それでは、ただいまよりプレゼンテーションを開始させていただきます。

So what are they like how they might already present, there. So okay supposed to data that's the math.

Christophe Weber: クリストフ、Please go ahead.

Crystal. Please go ahead.

Ayako Iwamura: Thank you Ayako and thank you everyone for joining us today.

Christophe Weber: So I think it's really great for us first to be able to file this indication for IQVI.

Thank you Nicole and thank you everyone for joining us today.

Christophe Weber: Our purpose is to create better health for people, brighter future for the world by discovering and delivering life transforming treatments, with a commitment to patients across the world, to our people and to the planet.

Christophe Weber: And again, IQVI is a very competitive device and a very competitive formulation, very convenient for patients. So we think that the efficacy combined with this convenience will be a big add and a big plus for the patients.

Our purpose is to create better health for people a brighter future for the wallet.

Discovering and delivering life transforming treatments.

With a commitment to patients across the world to our people and to the planet.

Needless to say that this purpose is more relevant than ever.

Needless to say that the strategy is more relevant in Haverhill.

It's not only a moral imperative to create shareholder and societal value, but it's also a way to make the company stronger.

Not only are more encouraging to create shareholder and societal value, but it's also a way to make the company stronger.

Christophe Weber: Our performance in the first quarter of this fiscal year reinforced our ability to drive long term business goals. In the first quarter, core revenue was 972.5 billion yen, with growth at a constant exchange rate of 8.3%, driven by our growth and launch products. Co-operating profit for the quarter was 319.1 billion yen, growing at an impressive 17% on a constant exchange rate basis, and co-earnings per share grew 15.8% to 145 yen.

Yeah.

Our performance in the first quarter of this fiscal year reinforce our ability to drive long term business goals.

In the first quarter core revenue was $972 5 billion yen with growth at a constant exchange rate of eight 3% driven by our growth and launch products.

Core operating profit for the quarter was 300, $319 1 billion yen growing at an impressive 17% on a constant exchange rate basis and core earnings per share grew 15, 8% to 145 game.

This puts us well on track towards our full year guidance for fiscal year 2022 of low single digit core revenue growth and high single digit call betting profits on core EPS growth at constant exchange rates.

This put us well on track towards our full year guidance for fiscal year 2022 of low, single-digit core revenue growth and high single-digit co-operating profit on core EPS at constant exchange rate. On the reported basis, our strong business performance coupled with favorable foreign exchange enabled us to deliver a reported revenue growth of 2.4% and this is despite the large gain of 133 billion yen we booked as revenue in the first quarter of the last year related to the sale of a diabetes portfolio in Japan.

On a reported basis, our strong business performance, coupled with favorable foreign exchange enabled us to deliver a reported revenue growth of two 4%.

And this is despite the large gain of 133 billion yen, we booked as revenue in the first quarter of last year related to the sale of the diabetes portfolio in Japan.

On reported profit basis, this one-time transaction had an impact on the first quarter growth rate, but our full year outlook still anticipated double-digit reported operating profit and EPS growth.

On a reported profit basis. These one time transaction has an impact on the first quarter growth rate, but our full year outlook still anticipate double digit reported operating profit and EPS growth.

Christophe Weber: We continue to see progress in our commercial execution. Our diverse portfolio of growth, and launch product grew at an impressive 26% at constant exchange rate, driven by Antivio, Tacxaro, and our immunoglobulin franchise.

We continue to see progress in our commercial execution.

Our diverse portfolio of growth a launched product grew at an impressive 26% at consulting exchange rate driven by on TVO.

At the same time, we are very much focused on our, launch excellence, as I will detail in a few minutes.

Christophe Weber: The CIDP indication overall, let me remind you that overall, the CIDP indication represents about, 20% of the overall immunoglobulin market, globally.

Zero and our immunoglobulin franchise.

Andy Plump: And on the, this is Andy, Kyogi-san, on the Arrowhead TACC-999 question.

At the same times, we are very much focused on our launch excellence as I will detail in a few minutes.

Christophe Weber: Andy will detail our pipeline progress shortly, so I would like to now give you an update on our most recent launches in the US.

Andy Plump: So just again to remind you, just the data that we've seen so far in the open label study, ongoing open label study has been just so remarkable in terms of the percent knockdown. We're seeing 90% knockdown of the mutant alpha-1 antitrypsin RNA.

Andy will detail our pipeline progress shortly so I would like to now give you an update on our most recent launches in the U S.

Christophe Weber: Let's start with Liftensity, which is redefining the way ketone megalovirus or CMV infection is, treated. Patients now have access to a therapy that can enable sustained and effective treatment against post-transplant CMV infection, which could save an organ or a life that might otherwise be lost.

Andy Plump: We're seeing almost 85% knockdown of the mutant protein aggregate.

Let's start with defensive G, which is redefining the way she to maybe make a little bit resource CMV infection is treated.

Patients now have access to a therapy that can enable sustained and effective treatment against post transplant, CMV infection, which could save inorganic or lives that might otherwise be lost.

As CMV is one of the most common and serious post-transplant infection, recent data support the meaningful impact we are seeing.

Our CMV is one of the most common on <unk> post transplant infection reason that is cheaper the meaningful impact we have seen.

Andy Plump: We're seeing trends towards reductions in liver function tests.

At recent medical meetings, we presented data on our new exploratory analysis, showing that patients treated with intensity has reduction in hospitalization and length of hospital stay compared to those treated with conventional anti viral therapies.

At the recent medical meetings, we presented data on a new exploratory analysis showing that patients treated with Liftensity had a reduction in hospitalization and length of hospital stay, compared to those treated with conventional antiviral therapies.

Andy Plump: And on biopsy, again, non-controlled setting, but we're seeing actually a regression in fibrosis over very short time periods of 24 and 48 weeks.

Andy Plump: And so the data that we've seen to date are compelling enough to drive a go decision for a pivotal study.

We are also seeing promising momentum since the launch in December 21. 56% of the 314 US transplant centers have initiated therapy with at least one patient, and the demand is continuing to grow.

We are also seeing promising momentum since the launch in December 'twenty one.

56% of the 314 U S transplant centers have initiated therapy with at least one patient and demand is continuing to grow.

Our global expansion plan is underway, with an EU approval decision expected in the second half of fiscal year 2022.

Our global expansion plan is underway with an EU approval decision expected in second half of fiscal year 2022.

We also anticipate phase 3 data for Liftensity, which could expand use in first line.

We also anticipate phase III that therefore intensity, which could expand use in first line. We expect the readout at some point later this fiscal year.

We expect, the readout at some point later this fiscal year.

We are very proud of the impact of this transformative treatments patients who would otherwise be vulnerable to CMV now have hope on the better quality of life.

We are very proud of the impact of these transformative treatments.

Patients who would otherwise be vulnerable to CMV now have hope and a better quality of life.

Christophe Weber: I'd like to talk about another launch product, XCVT.

I'd like to talk about our newest avalanche photo <unk>.

Christophe Weber: Excivity is an important new treatment for adult patients with locally advanced or metastatic, non-small cell lung cancer. It is the first and only approved oral therapy designed to target EGFR exon 20 insertion, mutation for patients whose disease has progressed on or after platinum-based chemotherapy.

<unk> is an important new treatment for adult patients with locally advanced or metastatic non small cell lung cancer.

This is the first and only approved oral therapy designed to target Egfr exon 20 insertion mutation.

For patients, whose disease has progressed on or after that genome based chemotherapy.

The very unique and distinct value of this important treatment combined with our launch, capability is driving its success.

The very unique and distinct value of this important treatment combined with our launch capability is driving its success we.

Christophe Weber: We see it in the continued progress following the launch in the U.S. We are continuing to see better than expected new patient starts and have now reached 50% exon 20 market share in U.S.

We see continued progress following the launch in the U S.

We are continuing to see better than expected new patient starts and have now reached 50% <unk> market.

<unk> market share in U S.

Following approval in the U.S. and the U.K., we continue to receive approval from health, authorities around the world, much recently in Switzerland, Australia, and South Korea.

Following approval in the U S and the UK, we continue to receive approval from health authorities around the world. Most recently in Switzerland, Australia, and South Korea.

However, in the EU, we decided to withdraw the EU marketing authorization application, filing in second line non-small cell lung cancer following discussion with the CHMP, where the committee indicated that additional clinical data would be needed to confirm benefits for mobustatinib in the second line.

However, in the EU, we decided to withdraw the EU marketing authorization application filing in second line non small cell lung cancer following discussion with <unk>.

Whereas the committee indicated that additional clinical data would be needed to confirm benefit for mobile certainly in the second line.

Pending outcome from the phase 3 trial in first line EGFR exon 20 insertion non-small, cell lung cancer, we plan to pursue approval in the EU. This first line trial is event-driven and is targeted for submission in fiscal year, 2024.

Pending the outcome from the phase III trial in first line Egfr exon 20 insertion.

Small cell lung cancer, we plan to pursue approval in the EU.

This first line trial is event driven and is targeted for submission in fiscal year 2024.

Christophe Weber: We remain confident that XPVT offers an effective treatment option for patients suffering from, this difficult-to-treat cancer and are hopeful that we will continue to make important progress on bringing this treatment to patients in need.

We remain confident that the activity of course, an effective treatment option for patients suffering from this difficult to treat cancer and are hopeful that we will continue to make important progress on bringing this treatment to patient needs.

Christophe Weber: In closing, this quarter is yet another example of our ability to deliver on our mission to, transform the life of patients while driving long-term financial growth.

In closing this quarter is yet another example of our ability to deliver on our mission to transform the lives of patients.

While driving long term financial growth.

This result reinforces that our strategy is working, specifically the launch of our new, innovative products, our deliberate investment in data and digital, and also commitment to sustainability.

These results reinforce that our strategy is working specifically the launch of our new innovative products.

Our deliberate investment in data and digital.

And also our commitment to sustainability.

We have an incredibly exciting time ahead.

We have an incredibly exciting time ahead patient by patient, we see the impact of the foundation to transform lives.

Christophe Weber: Patient by patient, we see the impact of our mission to transform lives.

Christophe Weber: I now would like to hand over to Andy to introduce our pipeline updates in more detail.

Now I'd like to hand over to Andy to introduce our pipeline updates in more detail. Thank you.

Thank you.

Andy Plump: Thank you very much, Christophe, and hello to everyone on the call today.

Andy Plump: The placebo-controlled blinded phase 2 data that will be coming out later this year, of course, those data will be presented at Congress, but it's important to note that that study is being run by our collaborator, Arrowhead, so they'll be responsible for that presentation.

Yeah.

Thank you very much Christophe and Hello to everyone on the call today.

Andy Plump: As Christophe mentioned, the impact we are seeing on the lives of patients is the key, factor to our success.

As Christoph mentioned the impact we are seeing on the lives of patients is the key factor to our success we.

We see this impact so clearly as we make progress in our pipeline.

We see this impact so clearly as we make progress in our pipeline.

Andy Plump: The opportunity to bring transformative medicines to patients is an inspiring and motivating, force for all of our scientists.

The opportunity to bring transformative medicines to patients is an inspiring and motivating force for all of our science tests I think youll see this today as I walk through a few highlights from the first quarter next slide please.

Andy Plumb: I think you'll see this today as I walk through a few highlights from the first quarter.

Andy Plump: I think that data set will be important in helping us further understand the overall profile of the molecule, but we believe based on the data that we've seen so far that we have enough compelling evidence to move forward.

Andy Plump: We strongly believe that we're going to need a full phase 3 study for approval, and our hope is that we'll be starting that phase 3 study this year. The specific endpoints for that study, we're in the process of discussing those with FDA and other agencies.

Next slide, please.

Ayako Iwamura: ありがとうございました, ありがとうございました それでは続いてのご質問は

unknown: JPモルガン証券の若尾様、リュートを解除してお話しください はい、JPモルガンの若尾です。よろしくお願いします 一つ目が結晶分割制材事業の限界値についてです, 前期4Qと比べてこの1Qは減価率は改善しているのでしょうか また今回お示しいただいた 報酬額の低減による減価率の改善はいつ頃から見込めるのでしょうか 加えて報酬額の低減というのが, 通期計画に織り込み済みなのかもあわせて教えてください 二つ目が半関比に関してです この1Qの半関比が円圧の状況にも関わらず 非常にうまくコントロールできている印象です, 半関比の計画を発表されていないことをよく理解しているのですが この1Qの計画に対する進捗をコメントいただけませんでしょうか また2Q以降円圧のネガティブ影響があると思うのですが この1Qの状況というのが2Q以降も続けられるかどうか, 半関比に関して見通しを教えてください 以上です 次のステップについては ドナーの費用の低減についての説明をさせていただきます, SG&Aのコントロールについては 全体のSG&Aの低減は 最大の影響を受けているのですが 過去と今のデータ・デジタル・テクノロジーの投資による影響を受けています, サイエンスとマーケティングについては 特にオムニチュアル・ターゲッティングに関するデータ・デジタル・テクノロジーを利用しています 医者等については 特にG&Aのサービスを利用しています, また データ・デジタル・テクノロジーのオーディメーションを利用しています また タケタのビジネス・ソリューション・センターを利用しています, バックオフィス・トランザクションの活動を 増やしています 特にHR・プロキュメント・ファイナンスを利用しています, これらの活動は 全体のプロダクティビティーとエフィシエンシーを向上させるために役立ちます これらのプログラムについては 非常に満足しています, これらのプログラムについては 引き続き進めていきたいと考えています ご質問ありがとうございました, はい ありがとうございます 若男さん ありがとうございました, では 続いてのご質問は

unknown: 台湾証券の橋口様 ミュートを解除してお話ください, 橋口です ありがとうございます 質問は一つです, COVID-19ワクチンの売上はどれほどだったんでしょうか 通期で500億円の想定だったと思いますけれど, 1クォーターでどこまで立ったのかというのを教えてください また 最新の見通しとしては, 500億円を上振れる可能性が高まっているということはないでしょうか

Andy Plump: There's a lot of enthusiasm here about our dengue vaccine. We recently presented the final data for TAC003 and are very pleased with the long-term efficacy, against hospitalizations as well as protection against dengue disease, which was maintained throughout the 4.5 years of our pivotal trial.

unknown: 以上です

There's a lot of enthusiasm here about our dengue vaccine. We recently presented the final data for TAC 003, and are very pleased with the long term efficacy against hospitalizations as well as protection against dengue disease, which was maintained throughout the <unk>.

Costa Saroukos: Thank you very much, Hashiguchi-san.

Costa Saroukos: It's Costa here.

Costa Saroukos: Revenue for the first quarter was 19.4 billion yen, which is a combination of both Spike Vax and Nuvaxavid.

Costa Saroukos: At this stage, we're holding on the target of the 50 billion yen, so no further up at this stage, but we're very happy with the start of the fiscal year. So that's where we're tracking 19.4 billion for Q1, and we're maintaining the guidance of 50 billion yen for the full year.

Costa Saroukos: Thank you.

Four five years of our pivotal trial, we will share these results with you shortly.

We will share these results with you shortly.

Costa Saroukos: Thank you very much.

Andy Plump: We reported positive phase 3 data for hycuveia in CIDP, a chronic autoimmune and inflammatory, disease that affects the peripheral nervous system. Most of the patients in the ADVANCE Pivotal Trial on active treatment received hycuveia, subcutaneously every four weeks. This convenient dosing and ability to self-administer at home has the potential to reduce the burden, of chronic immunoglobulin treatment.

Costa Saroukos: Thank you very much, Hashiguchi-san.

We reported positive phase III data for <unk>, and <unk> E. P. A chronic autoimmune and inflammatory disease that affects the peripheral nervous system.

unknown: The next question is from Sakai-sama from the Credit Suisse Provincial Government.

Most of the patients in the advance pivotal trial on active treatment receipts. The IQ <unk> subcutaneously every four weeks.

This convenient convenient dosing and the ability to self administer at home has the potential to reduce the burden of chronic immunoglobulin treatment.

Andy Plump: Patients with alpha-1 antitrypsin-associated liver disease were treated with Fasirsiram, our first-in-class RNAi therapy, in an open-label phase 2 trial. The strong results were published in the New England Journal of Medicine, and highlights, include the regression of fibrosis in 7 out of 12 patients and a median 83% reduction in accumulated Z-AAT protein in the liver. This is the key pathologic aggregate that causes inflammation and can lead to fibrosis, and an eventual liver transplant.

unknown: Please unmute and speak.

Patients with Alpha one antitrypsin associated liver disease.

unknown: Hello, this is Sakai speaking from Credit Suisse.

Treated with <unk>, our first in class RNA therapy, and an open label Phase III trial.

unknown: So two questions.

The strong results were published in the New England Journal of Medicine.

unknown: The trend of, retentivity and extensivity, the first quarter seems to be a little bit lower than what actually our expectations, and when we're going to see the spike in the sales trend going forward.

Highlights include the regression of fibrosis in seven out of 12 patients and immediate and 83% reduction in accumulated Z <unk> protein in the liver.

This is the key pathologic aggregate that causes inflammation and can lead to fibrosis and eventually an eventual liver transplant.

These early results demonstrate the potential for Fasirsiram to one day help these patients, avoid liver transplant.

unknown: Now, you mentioned about important first line indications for both drugs, but that's a year away.

These early results demonstrate the potential of our business around to one day help these patients avoid liver transplant.

Andy Plump: Completing our clinical updates, TACS280, a conditional B7H3-targeted bispecific T-cell, engager designed to treat solid tumors, entered the clinic this quarter. This is the second program that we have entered into the clinic from Maverick Therapeutics, our bill-to-buy acquisition completed last year.

unknown: So what's going to be the trigger for, you know, that spike in the sales trend for these two important – both the important new products?

Completing our clinical updates package to a D. A conditional <unk> III targeted bispecific T cell engaging are designed to treat solid tumors entered the clinic this quarter.

unknown: That's the first question.

unknown: And second question is TAC H6-1.

unknown: If I'm not mistaken, you are going to have the internal readout of the Phase 1, data sometime in August.

This is the second program that we have entered into the clinic from Maverick Therapeutics are built by acquisition completed last year.

Andy Plump: And as Christoph highlighted earlier, we have in-licensed an exciting hyperthiolated, immunoglobulin candidate from Momenta Pharmaceuticals. This therapy has the potential to increase potency, allowing for significantly lower, doses.

And as Christoph highlighted earlier, we have in licensed an exciting hypersound violated immunoglobulin candidate for momentum pharmaceuticals.

This therapy has the potential to increase potency, allowing for significantly lower doses.

Andy Plump: If you go to the next slide, 10, please.

If you go to the next slide 10 please.

Here are our 10 late-stage development programs.

Here are 10 late stage development programs.

Andy Plump: Nivaxavid was approved early this fiscal year and is now available in Japan, adding to the, armaments against COVID-19.

<unk> was approved early this fiscal year and is now available in Japan, adding to the argument against COVID-19.

Andy Plump: Modaclifosbalza is our first-in-class immunocytokine that delivers an attenuated interferon to, tumor and immune cells in a highly targeted manner. Updated results presented at the European Hematology Association for single-agent Modaclifosbalza, show an overall response rate of 43%, with multiple complete responses in heavily pre-treated patients, importantly, including those refractory to anti-CD38 therapies.

<unk> is our first in class immuno cytokines that delivers an attenuated interferon to tumor and immune cells and a highly targeted manner.

Updated results presented at the European Hematology Association for single agent Metastasize valves that show an overall response rate of 43% with multiple complete responses in heavily pretreated patients importantly, including those refractory to anti CD 38 therapy.

Andy Plump: This quarter, we started the first of a series of phase 2 trials for Modaclifosbalza, our, lead innate immune program, which will define its path forward in relapsed or refractory multiple myeloma.

Yes.

This quarter, we started the first of a series of phase II trials for <unk>, our lead innate immune program.

Graham, which will define its path forward and relapsed or refractory multiple myeloma.

Next slide, 11, please.

Next slide 11 space.

Andy Plump: We continue to be excited about our proof-of-concept readouts to come over the course of the next, two years.

unknown: And once you find any new – well, if it's a good result or bad result, what is your plan to disclose the outcome of this readout?

We continue to be excited about our proof of concept readouts to come over the course of the next two years.

These are the first of many new molecular entities that could emerge from our rich and, transformative early-stage pipeline and add to our growing list of late-stage development programs.

unknown: That's my two questions.

These are the first of many new molecular entities that could emerge my rich and transformative early stage pipeline and add to our growing list of late stage development programs.

Christophe Weber: Thank you.

Christophe Weber: Thank you, Sakai-san.

Here are select expansion opportunities we have for our major brands.

Next slide 12 please.

Here, our select the expansion opportunities we have for our major brands we.

Andy Plump: We expect to file Taxiro for the prevention of hereditary angioedema in children ages, 2 to 12 in the near future. This filing is based upon the outstanding data presented at the European Academy of, Allergy and Clinical Immunology in July. Taxiro demonstrated an approximately 95% reduction in HAE attacks when compared to baseline. Most of these children averaged nearly two attacks per month before entering the trial, and a majority of them remained attack-free during the full 52-week treatment period, a result not seen with any other agents.

We expect to file tax iroh for the prevention of hereditary angioedema in children ages, two to 12 in the near future.

This filing is based upon the outstanding data presented at the European Academy of allergy and clinical immunology.

In July .

X Io demonstrated an approximately 95% reduction in HAE attacks when compared to baseline.

Most of these children averaged two attacks per month before entering the trial and a majority of them remained attack free during the full 52 week treatment period, a result, not seen with any other agent.

Andy Plump: And as mentioned, we also expect to file Hycubia in the U.S. and EU as maintenance, therapy for patients with CIDP based upon the positive results announced just this past month.

And as mentioned, we also expect to file <unk> in the U S and EU as maintenance therapy for patients with <unk> E. P. Based upon the positive results announced just this past month. So next slide 13.

So next slide, 13.

Andy Plump: We have some key regulatory approvals and phase 3 readouts underway. Before we discuss our exciting data for TAC003 and Hycubia, we wanted to highlight upcoming, data in Q2 for live density. As Christophe mentioned, we expect the top-line phase 3 live density data in first-line post-transplant, CMV infection to read out in the second quarter. This trial compares live density against the current standard of care, valganciclovir, in patient with first CMV infections following hematopoietic stem cell transplant.

We have some key regulatory approvals and phase III readouts underway.

Before we discuss our exciting data for <unk> three in <unk>, we wanted to highlight upcoming data in Q2 for lived density.

Christophe Weber: It's Christophe here.

As Christophe mentioned, we expect the top line phase III Tensity data in first in first line post transplant CMV impaction to readout in the second quarter.

This trial compares <unk> tensity against the current standard of care, Val Ganciclovir and patient with first CMV infections. Following a matter of poetic stem cell transplant.

Andy Plump: In phase 2, live density showed a numerically higher rate of CMV viremia clearance versus, valganciclovir with a significantly lower rate of neutropenia at 5 versus 18%. Neutropenia is an independent predictor of mortality in stem cell transplant patients. Live density's favorable safety profile, especially its lack of neutropenia, represents, a potentially significant therapeutic advance for these patients.

In phase two the intensity showed a numerically higher rate of CMV viremia clearance versus Val ganciclovir with a significantly lower rate of neutropenia at five versus 18%.

Neutropenia, as an independent predictor of mortality and stem cell transplant patients.

With entities favorable safety profile, especially its lack of neutropenia represents a potentially significant therapeutic advance for these patients.

Andy Plump: The late-stage data readouts shown here will allow for global filing in these indications, with future label expansion opportunities to come.

The late stage data Readouts shown here will allow for a global filing and these indications with future label expansion opportunities to come. So now let's look at some of our data. If we can go to slide 14. Please.

So now let's look at some of our data.

Christophe Weber: So I think we are not disappointed at all by the Q1, actually.

If we can go to slide 14, please.

Christophe Weber: We are very pleased with the update, but, you know, you need to – when you launch a product like Lifton CT, first you need to have the product reference in the different transplant center.

Andy Plump: As Christophe noted, we are very encouraged by the final four and a half year data from, our dengue vaccine candidate, PAC003. The analyses are complete, and the new drug application has been submitted in the EU. Dengue is a rapidly spreading mosquito-borne viral illness. It has been defined as a top 10 health problem by the World Health Organization.

Christophe Weber: I think we have achieved that very, very well.

Christophe Weber: The majority of the transplant centers now have, a reference with Lifton CT, and 56% of the 314 transplant centers in the U.S. have already used it.

As Christoph noted we are very encouraged by the final four and a half year data from our dengue vaccine candidate Tak 003.

The analyses are complete and the new drug application has been submitted in the EU.

Christophe Weber: So it will take a while to translate that into revenue, but it will happen.

Danny is a rapidly spreading mosquito borne viral illness. It has been defined as a top 10 health problem by the World Health organization.

Christophe Weber: And then, of course, the first line is the key here.

Christophe Weber: The majority of the value will be in the first line indication, so we'll see it starting next year and the year after.

Andy Plump: While mortality from dengue is relatively low, severe dengue infection can be devastating, for patients, sometimes leading to hospitalization. For regions that experience a dengue epidemic, hospitals can become overrun with patients, requiring supportive care.

Christophe Weber: So that's Lifton CT. And keep in mind also that Lifton CT overall potential, revenue potential, is higher than Exquity as well.

While mortality from dengue is relatively low severe dengue infection can be devastating for patients sometimes leading to hospitalization.

For regions that experienced a dengue epidemic hospitals can become overrun with patients requiring supportive care.

And so the secondary consequences for patients with other diseases can be substantial, not, unlike what we have seen with COVID.

And so the secondary consequences for patients with other diseases can be substantial not unlike what we have seen with COVID-19.

There is an incredible unmet medical need, and we are ready to meet that need with a, really good vaccine.

Christophe Weber: And on Exquity, it's also – the first line is also very critical.

There is an incredible unmet medical need and we are ready to meet that need with a really good vaccine or four and a half year data continue to support sustained efficacy.

Christophe Weber: The first line indication, is also very critical.

Our four and a half year data continue to support sustained efficacy. What we show here with patients at baseline who are seropositive or seronegative is an, incredible 84% reduction in hospitalization. Hospitalization is an indicator of severe forms of dengue.

What we show here with patients at baseline, who were cero positive or zero negative is an incredible 84% reduction in hospitalization.

Hospitalization as an indicator of severe forms of dengue.

Andy Plump: As we have seen with COVID, it's not just if you can prevent infection, but if you can, prevent severe infection, it's clear that we can do both with our vaccine.

As we've seen with Covid, it's not just if you can prevent infection.

But if you can prevent severe infection, it's clear that we can do both with our vaccine now the efficacy does vary by serotype, we have strong efficacy in serotypes, one and two which are the most common.

Andy Plump: Now the efficacy does vary by serotype. We have strong efficacy in serotypes 1 and 2, which are the most common.

We have strong efficacy in serotype 3 patients with previous dengue infections.

We have strong efficacy in serotype three patients with previous dengue infections. However, we have no efficacy in serotype three patients who are seronegative.

However, we have no efficacy in serotype 3 patients who are seronegative.

Andy Plump: And to date, we do not have enough data in serotype 4 to draw conclusions.

And to date, we do not have enough data in serotype before to draw conclusions now allow me to highlight the hospitalization data from the last 18 months of the trial in the lower right.

Andy Plump: Now allow me to highlight the hospitalization data from the last 18 months of the trial, in the lower right. We are most reassured by the zero hospitalizations seen in the seronegative arm for patients, on PAC003 versus placebo.

We are most reassured by the zero hospitalizations scene in the seronegative arm for patients on <unk> 003 versus placebo.

Andy Plump: We believe these data will be reassuring to physicians and importantly regulators.

We believe these data will be reassuring to physicians and importantly regulators.

Andy Plump: We are currently under review in the EU.

Andy Plump: We believe these data continue to support a favorable benefit risk profile and are hopeful, for a positive decision in the next few months.

We are currently under review in the EU.

We believe these data continue to support a favorable benefit risk profile and are hopeful for a positive decision in the next few months. We can go to the next slide 15. Please.

If we can go to the next slide, 15, please.

CIDP is a rare autoimmune and inflammatory disorder that causes demyelination and damage, to peripheral nerves. The exact cause is unknown, but patients feel progressive weakness and impaired sensory, function in their legs and arms, often leading to pain, fatigue, and other symptoms. This is a chronic condition that requires long-term therapy. The treatment goal is to maintain durable remission with therapies such as IVIG.

See I D. P is a rare autoimmune and inflammatory disorder that causes demyelination and damage to peripheral nerves.

Exact cause is unknown, but patient still progressive weakness and impaired sensory function and their legs and arms, often leading to pain fatigue and other symptoms. This is a chronic condition that requires long term therapy.

The treatment goal is to maintain durable remission with therapy, such as IV Iga.

IVIG, of course, can have its own challenges due to the need for venous access by a healthcare, provider.

The idea of course can have its own challenges due to the need for venous access by a health care provider.

So, a facilitated subcutaneous immunoglobulin like IQVIA should help address an important, need for patients with CIDP.

So a facilitated subcutaneous immunoglobulin like <unk> should help address an important need for patients with <unk>. We are very excited by the positive results in this phase III study.

We are very excited by the positive results in this phase 3 study.

In the ADVANCE-1 trial, the IQVIA arm showed a significant difference in relapse rate compared, with the placebo arm when used as maintenance therapy in CID patients with a favorable safety profile.

In the advance one trial the high acuity arm showed a significant difference in relapsed rate compared with the placebo arm when used as maintenance therapy in CIB patients.

Importantly, most of the patients achieved these results with a once-every-four-week, regimen using IQVIA, which is less frequent than any conventional subcutaneous immunoglobulin on the market.

With us with a favorable safety profile.

Importantly, most of the patients achieved these results with a once every four week dosing regimen using Ikea.

Which is less frequent than any conventional subcutaneous immunoglobulin on the market.

These data will be presented at an upcoming medical meeting.

Konstantin Saroukos: Thank you, Andy, and hello, everyone.

Christophe Weber: This is where there is a highest market value.

These data will be presented at an upcoming medical meeting.

And be used to file for approval in both the U S and EU later this fiscal year.

So we conclude with two exciting datasets that in the near future could bring new therapies and indications to benefit our patients.

And I will now turn it over to Costa faster.

Thank you, Andy and Hello, everyone business cost of service cost speaking, it's my pleasure to explain with fiscal 2022 first quarter financial highlights we are off to a strong start in fiscal 2022 with core revenue growing eight 3% at constant exchange rate and 19.

Konstantin Saroukos: This is Konstantin Saroukos speaking.

Christophe Weber: So I think this product will be successful.

Konstantin Saroukos: It's my pleasure to explain the fiscal 2022 first quarter financial highlights. We are off to a strong start in fiscal 2022, with core revenue growing at 8.3 percent at constant exchange rate and 19.1 percent when, factoring in the FX tailwind. This strong performance was driven by global and launch products such as Intibio, Tax Zyro and Immunoglobulin as we delivered growth in all geographic regions.

Christophe Weber: You know, the early signs are very strong that these two products will be very successful. We just need to have the full set of indications to translate that into revenue potential.

Andy Plump: And Sakai-san, on PAC 861, just to be clear, and I'm sorry if there was a misunderstanding, we will not have a data set that will enable us to make a decision, a go-no-go decision in August.

Andy Plump: What we've disclosed is that we'll have a decision, a go-no-go decision by the end of this year. So just so that we're clear in terms of timelines. End of this year, that's what you're saying right now.

Andy Plump: That's right.

Andy Plump: And that's, I think, what we've been guiding all along.

Andy Plump: You know, nothing's, changed since we have, you know, since we made the transition from 994 to 861 in terms of our acceleration.

Andy Plump: And, you know, the data set that will enable this trend, this decision will be healthy volunteer, sleep-deprived data, and then also type 1 narcolepsy patients treated for a month.

1% when factoring in the FX tailwind.

This strong performance was driven by global and launched products such as Entyvio <unk> Xyrem any music globally as we delivered growth in all geographic regions.

In addition, we also are excited with what we've seen so far in the new launches of Liptensity and Xcivity.

Andy Plump: So we're in the process of, you know, accumulating that blinded data set now.

Konstantin Saroukos: Our reported revenue growth was 2.4 percent, impacted by the 133 billion yen gain from the sale of the Japan diabetes business that was booked in Q1 of the, prior year. This one-time event is the only difference between reported and core revenue.

Andy Plump: Okay.

In addition, we also are excited with what we've seen so far in the new launches of intensity and excuse me.

Our reported revenue growth was two 4%.

Andy Plump: Thank you.

Impacted by the 133 billion gain from the sale of the Japan diabetes business that was booked in Q1 of the prior year.

This one time event is the only difference between reported and core revenues.

Konstantin Saroukos: Our core operating profit, which excludes this divestiture gain, grew 17 percent at constant, exchange rate to 319.1 billion yen for the quarter.

Our core operating profit, which excludes this divestiture gain grew 17% at constant exchange rate.

Konstantin Saroukos: Our core operating profit margin was 32.8 percent, an increase of 2.3 percentage points on a year-over-year basis. This was partly because of the resolution of the Intibio shipment phasing that we experienced in Q4, and partly a reflection of our broad-based portfolio growth and focus on cost control.

Two to $319 1 billion yen for the quarter.

Our core operating profit margin was 32, 8% an increase of two three percentage points on a year over year basis. This was partly because of the resolution of being TBA shipment phasing.

We experienced in quarter, four and partly a reflection of our broad based portfolio growth and focus on cost control.

Konstantin Saroukos: Net debt to adjusted EBITDA remains at 2.8 times despite the year-end dividend payment, and on all measures, we are on track towards the full-year management guidance we provided in May.

Net debt to adjusted EBITDA remains at $2 eight because part of that.

Sorry remains at three eight times, despite the year end dividend payment and on all measures. We are on track towards the full year management guidance, we provided in may.

Ayako Iwamura: Sakai-san, arigatou gozaimashita.

Konstantin Saroukos: Let me go into more detail on the Q1 revenue performance versus prior year on slide 19. On the left-hand side, you can see a waterfall chart for reported revenue, which grew at 2.4 percent despite the full impact of the 133 billion yen we booked in Q1 of last year from the sale of Japan diabetes portfolio.

unknown: Tsuzuite no go-shitsumon wa Goldman Sachs shouken no

Let me go into more detail on the Q1 revenue performance versus prior year on slide 19 on the.

unknown: Ueda-sama.

unknown: Mute wo kaijou shite ohanashi kudasai.

The left hand side, you can see a waterfall chart for reported revenue, which grew at two 4%. Despite the full impact of the 133 billion yen, we booked in Q1 of last year from the sale of Japan diabetes portfolio.

Konstantin Saroukos: Core revenue on the right-hand side excludes this, and you can see, our business momentum was driving 8.3 percent growth at constant exchange rate. Foreign exchange has also been a significant tailwind for us due to the depreciation of the yen, adding over 10 percentage points of growth to core revenue in the quarter.

Core revenue on the right hand side excludes these and you can see our business momentum was driving a 3% growth at constant exchange rate.

Foreign exchange has also been a significant tailwind for us due to the depreciation of the yen.

Over 10 percentage points of growth to core revenue in the quarter.

Konstantin Saroukos: On slide 20, we show the drivers of reported and core operating profit for the quarter.

On Slide 20, we show the drivers of reported and core operating profit for the quarter.

Konstantin Saroukos: Reported operating profit was 150.5 billion yen, a decline of 39.4 percent versus prior year. Again, the decline is predominantly coming from the sale of the Japan diabetes portfolio last year.

Reported operating profit was 155 big again, a decline of 39, 4% versus prior year.

The decline is predominantly coming from the sale of the Japan diabetes portfolio last year. However.

Konstantin Saroukos: However, because that was a one off event in quarter one of prior year, the impact will, diminish over the remainder of this fiscal year.

However, because that was a one off event in quarter one of prior year the impact will diminish over the remainder of this fiscal year and we are forecasting full year reported operating profit growth of 12, 8%.

Konstantin Saroukos: And we are forecasting full year reported operating profit growth of 12.8%. Co-operating profit was 319.1 billion yen, with our business momentum driving 17% growth at constant exchange rate and foreign exchange an incremental tailwind of around 11 percentage points.

Operating profit was $319 1 billion yen with our business momentum driving 17% growth.

Konstantin Saroukos: On slide 21, you can see our growth by key business area.

Constant exchange rate and foreign exchange, an incremental tailwind of around 11 percentage points.

On Slide 21, you can see our growth for our key business area.

Konstantin Saroukos: We have a balanced growing portfolio. Our growth and launch products continue to be key drivers, generating 2.7 billion US dollars of revenue in the quarter and delivering 26% growth at constant exchange rate. GI, our largest business area by revenue, grew at 15% with growth of interior across all markets driven by continued share growth in bionary patients.

We have a balanced growing portfolio.

Our growth and launch products continue to be key drivers generating $2 7 billion U S dollars of revenue in the quarter and delivering 26% growth at constant exchange rate.

Gee I, our largest business area by revenue grew at 15% with growth of interior across all markets driven by continued share growth in binary patients in rare disease, which grew 7%, we see continued demand growth and geographic expansion for <unk>.

Konstantin Saroukos: In rare disease, which grew 7%, we see continued demand growth and geographic expansion for taxara, as well as a successful new launch of liptensity.

Konstantin Saroukos: PDT immunology continues to be very strong with, 18% growth, which I will introduce in more detail on the next slide.

Zara as well as a successful new launch of lipid density.

PDT immunology continues to be very strong, 18% growth, which I'll introduce more detail on the next slide.

Konstantin Saroukos: You will note that oncology business area is declining year on year, as was expected, given Velcae Generics entered the US market from May this year.

You will note the oncology business area is declining year on year as was expected given brocade generics entered the U S market from May this year.

Konstantin Saroukos: Neuroscience continues to be strong, driven by Thymans and Trintellix.

Konstantin Saroukos: And the other segment has benefited from revenue from our COVID-19 vaccines in Japan.

Neuroscience continues to be strong driven by Vyvanse and <unk>.

Konstantin Saroukos: I mentioned our strong and sustained performance in plasma drive therapies, where we have successfully navigated pandemic pressures.

And the other segment has benefited from revenue from our COVID-19 vaccines in Japan.

I mentioned, our strong and sustained performance in plasma derived therapies, where we have successfully navigated pegged him make pressures looking ahead, we have considerable potential to continue to grow this business and extend the impact all of our therapies to new patient populations around the world.

Konstantin Saroukos: Looking ahead, we have considerable potential to continue to grow this business and extend the impact of our therapies to new patient populations around the world.

Konstantin Saroukos: This quarter is evidence of that.

Konstantin Saroukos: Our PDT immunology business delivered revenue growth of 18%, tracking towards the high end, of our full year guidance. Within this, our immunoglobulin portfolio grew at 22%, fueled by increased global demand, coupled with steady and growing supply.

World.

This quarter is evidence of that.

Our PDT immunology.

<unk> delivered revenue growth of 18% tracking towards the high end of our full year guidance.

Within this our global and portfolio grew at 22% fueled by increased global demand, coupled with steady and growing supply.

Konstantin Saroukos: Our primary objective is to maintain continuity of patient supply, which requires consistent, plasma volume growth as new patients are brought onto therapy. We have delivered plasma donation volumes above pre-pandemic levels for over one year, and continue to build on this momentum.

Our primary objective is to maintain continuity of patient supply, which requires consistent plasma volume growth.

New patient abroad onto therapy.

We have delivered plasma donation volumes above pre pandemic levels for over one year and continued to build on this momentum the growth of our bar like network is a key factor we added eight donation centers in the U S. In the first quarter, bringing our global donation it was to 212.

Konstantin Saroukos: The growth of our BioLife network is a key factor. We added eight donation centers in the US in the, first quarter, bringing our global donation network to 212.

Konstantin Saroukos: And we are on track to increase year-on-year donation volumes by 10 to 20% in fiscal year 2022.

And we are on track to increase year on year donation volumes by 10% to 20% in fiscal year 2022.

Konstantin Saroukos: The past two years have demanded that we do more with less plasma, and we have.

The past two years have demanded that we do more with less plasma and we have we are actively managing cost on a number of fronts to improve margins, including direct compensation.

Konstantin Saroukos: We are actively managing costs on a number of fronts to improve margins, including donor, compensation. In quarter one, we reduced donor compensation by approximately 15% compared to a year ago, leveraging new data and analytics capabilities.

In quarter, one we reduced the compensation by approximately 15% compared to a year ago, leveraging new data and analytics capabilities.

Konstantin Saroukos: We are also positioned to capture the full benefit of our digital and organization transformation, to improve PDP business margins over time.

We are also positioned to capture the full benefit of that.

Our digital and organizational transformation to improve PDP business margins overtime.

Konstantin Saroukos: Slide 23 shows the net balance compared to the end of March.

Slide 23 shows the net balance compared to the end of March free.

Konstantin Saroukos: Free cash flow was 42.6 billion yen, reflecting a step up in CapEx that captures two oncology, acquisitions, Gamma Delta and Adaptate, which we completed in April this year.

Free cash flow was $42 6 billion, reflecting a step up in capex that captures true oncology acquisitions Gamma Delta and the death rate.

Konstantin Saroukos: Also in April, we completed the share buyback initiated last year, and in June, we paid, the second half year dividend for fiscal year 2021. Despite the dividend payment, the completion of the buyback and step up in CapEx, we were, able to hold net debt to adjusted EBITDA at 2.8 times.

We completed in April this year.

Also in April we completed the share buyback initiated last year.

In June we paid the second half of the dividend for fiscal year 2021.

Despite the dividend payment the completion of the buyback and step up in Capex, we were able to hold net debt to adjusted EBITDA at two eight times.

Konstantin Saroukos: On slide 24, you can see our debt maturity ladder as of June. We paid down 20 billion yen of USD denominated debt in April, and still expect to pay down, a total 500 billion yen of debt in fiscal year 2022.

On slide 24, you can see our debt maturity ladder.

June .

We paid down 20 billion of USD denominated debt in April and still expect to pay down a total of 500 billion yen of debt in fiscal year 2022.

Konstantin Saroukos: I'm very pleased with how we've structured our debt profile, with a weighted average, interest rate of approximately 2%, and importantly, 98% of our total debt at fixed interest rates. In fact, the only outstanding debt still at floating rates will mature this year. So by the end of fiscal year 2022, we expect to be at 100% fixed rates. This gives us strong protection from any potential interest rate hikes.

I'm very pleased with how we've structured our debt profile with a weighted average interest rate of approximately 2% and importantly, 98% of our total debt at fixed interest rates in.

In fact, the only outstanding debt still at floating rates will mature this year.

By the end of fiscal year 'twenty, two we expect to be at 100% fixed rates.

Konstantin Saroukos: Furthermore, the currency breakdown of our debt very closely matches our cash flows.

This gives us strong protection from any potential interest rate hikes. Furthermore, the currency breakdown of our debt very closely matches. Our cash flows. So we are also protected against major currency fluctuation.

Konstantin Saroukos: So we are also protected against major currency fluctuations.

Konstantin Saroukos: On slide 25, we show the guidance we disclosed on May the 11th.

Konstantin Saroukos: We are on track and make no changes at this point.

On slide 25, we show the guidance, we disclosed a might be a limit.

Konstantin Saroukos: Our forecast is based on an FX rate assumption of 119 yen to the US dollar and 133 yen to the euro. And if we apply the June end FX rates to the rest of fiscal year 2022, for example, 136 yen to the US dollar, we would expect to see over 10 percentage points of incremental growth to our forecast for revenue, co-operating profit, and core EPS.

We are on track and make those changes at this point.

Our forecast is based on an FX rate assumption of 119 yen to the U S dollar and 133 game to the Euro and if we apply the June FX rates to the rest of fiscal year 2022. For example, 136 yen to the U S. Dollar we would.

Back to see over 10 percentage points of incremental growth to our forecast for revenues.

Konstantin Saroukos: To be precise, core revenue will be growing at around 19%, and our co-operating profit and core EPS at 29% and 28% respectively.

Cooperating profit and core EPS to be precise core revenue will be growing at around 19% and our core operating profit and core EPS at 29% and 28% respectively.

Konstantin Saroukos: We continue to expect to generate 6 to 700 billion yen of free cash flow.

Konstantin Saroukos: And finally, we remain fully committed to our dividend of 180 yen per share.

We continue to expect to generate six to 700 billion yen of free cash flow and finally, we remain fully committed to our dividend of 188 per share.

Konstantin Saroukos: To close out on the presentation on slide 26, I'd like to re-emphasize the key elements, of our strategy to deliver sustainable growth and value for our shareholders.

Two cloud to close out on the presentation on slide 26, I'd like to reemphasize the key elements of our strategy to deliver sustainable growth and value for our shareholders. We continue to see strong momentum from our commercial portfolio, which enabled us to deliver eight 3%.

Konstantin Saroukos: We continue to see strong momentum from our commercial portfolio, which enabled us to, deliver 8.3% core revenue growth at constant exchange rate. While we do face some loss of exclusivity headwinds in the next two years, we expect, momentum of our growth and launch products to support the top line over that period.

Core revenue growth at constant exchange rate.

Well, we do face some loss of exclusivity headwinds in the next two years, we expect momentum of our growth and launch products to support.

Konstantin Saroukos: Our margins are strong, with 32.8% core operating profit margin in Q1, and we delivered core, operating profit growth of 17% at constant exchange rate, well on track towards our full year guidance of high single digits.

The topline over that period.

Our margins are strong with 33, 8% core operating profit margin in Q1, and we delivered core operating profit growth of 17% at constant exchange rate well on track towards our full year guidance of high single digit.

Konstantin Saroukos: And our success is built on our solid financial foundation, with robust cash flow that we, will continue to allocate towards growth opportunities, continued deleveraging, and competitive shareholder returns. We have abundant liquidity and a well-structured debt profile of 98% fixed rates at an average, cost of 2%, which positions us well in the changing macro environment.

And our success is built on our solid financial Foundation.

With robust cash flows that we will continue to allocate towards growth opportunities.

<unk> deleveraging and competitive shareholder returns.

We have liquidity.

Liquidity.

And a well structured debt profile of 98% fixed rates at an average cost of 2%, which positions us well in the changing macro environment.

Konstantin Saroukos: In closing, we believe that Tequera is in a position of strength.

Konstantin Saroukos: Our Q1 results demonstrate a strong start to fiscal year 2022, and we are well on track, towards our guidance for the full year.

In closing, we believe that Takeda is in a position of strength.

Our Q1 results demonstrates a strong start to fiscal year 2022, and we are well on track towards our guidance for the full year, we look forward to taking your questions and thank you for your time.

Konstantin Saroukos: We look forward to taking your questions, and thank you for your time.

Yeah.

So that there are no somehow kind of don't quite small or just I don't want nothing.

Once its the small guy goes up I guess Mustang Crystal on the Costar Nicolai in Hong Kong. So now it looks like you must have some upfront gastonia Mas it.

Of course, the Milwaukee keep on a cappella Hamanaka several town Creek still or should I say kudos site, Jim Donegal night that's enough.

He hung with it sounds consolidator cabela the home for that.

And what their phone calls with that data, but a lot of people that smoke without site.

So you have got to know Mr. Ivan Okay that key data Nike to cut that law puts it on again, but I'm always smiling. So that's about all that kind of all this.

No.

He's on your open all of them enough money for phone calls that I thought. He said then you open up any concerns that I thought your mindset.

Konstantin Saroukos: I would like to start by taking all of your questions.

unknown: Hi, can you hear me?

Oh for 18 months ago small amount, we're studying email multiple subsidy, but that's tuck it sounds from us.

Thank you.

Some small some bad debt.

That's not enough.

Yeah, that's funny Guy that's enough.

Hidemaru Yamaguchi: First, we have a question from Mr. Yamaguchi of Citigroup.

Yeah.

Yeah.

So any color that's it for me, what's more than I thought and that's it.

Thank you.

Hidemaru Yamaguchi: Can you hear me?

unknown: Hai, kikoete orimasu.

So still good up in all your markets some of them.

Thank you very much.

unknown: Thank you for taking my questions.

So he thought I did miss it.

Hidemaru Yamaguchi: This is Yamaguchi from Citi.

unknown: I have one question.

Yes.

Uh Huh hiked by 30 months thank.

Two questions, please.

unknown: The question for this question, for the narcolepsy franchise.

Hidemaru Yamaguchi: The first question is regarding Q1 situations. You hinted that the full year number will surpass the full year guidance if you use, the current currency.

unknown: The company decided the discontinuation of the development TAC-994 based on the clinical data.

Thank you very much this is yamaguchi from Citi. Two questions. Please the first question was regarding.

Our Q1.

Situations.

You hinted that the full year number.

But can you tell me, even if you use the CL basis, I think your performance Q1 so far looks, better than the full year number.

So I'll pause there for a full year guide us if you use a new oh, here's the current currency.

But can you tell me, even if you use the Seattle basis, I think the Europe almost cure so far looks because on the free N. Umber. So can you give me a comment whether even using a C O youre too.

Hidemaru Yamaguchi: So can you give me a comment whether even using a CL your Q1 may be better than the full year number and why?

So that's the first question.

Hidemaru Yamaguchi: And the second question is that regarding 003 Dengue vaccine, Anderson hinted that there might, be some decision within a few months, which is a really good comment.

Maybe better than that free a number required so that's the first question.

But can you give me why you think it's a few months?

The second question is regarding or three dengue vaccine.

Hinted that there might be some decision within a few months, which is really a good comment but.

Hidemaru Yamaguchi: You did have interaction with the EU authorities.

Can you give me the why you would think of a few months you you did have found it felt like there was a U or therapies there.

Then you are now coming up to the conclusion just awaiting the decision from the EU should happen within a few months.

Hidemaru Yamaguchi: Thank you for the two questions.

And then you are now coming up to the conclusion.

Conclusion, just awaiting the decision from the U S.

Should happen within a few months. Thank you for the two questions.

Konstantin Saroukos: Thank you very much, Yamaguchi-san, for your question.

unknown: So could you share your thoughts on the factors behind, the development suspension for the TAC-994 and whether you think those factors will affect the safety profile of TAC-861?

Costa Fasano, and four months not including Yoga I, that's my smart when they go I guess method.

Yes. Thank you very much Yamaguchi San for your question were Firstly, let me say that we are very happy with the start of the year financials out how growth even at a constant exchange rate our margins released.

Firstly, let me say that we are very happy with the start of the year, our financials, our growth, even at a constant exchange rate, our margins, really, you know, we're doing well.

unknown: Thank you.

Konstantin Saroukos: It's a good start to the year.

We're doing well it's a good start to the year, having said that of course, we're continuing to monitor the situation in particular.

Konstantin Saroukos: Having said that, of course, we're continuing to monitor the situation, in particular, the Velcade generic penetration and erosion in the US is something that we continue to look at.

Konstantin Saroukos: We had generic entry in May, so, you know, already in May of this year.

The brocade generic penetration and erosion in the U S is something that we continue to look at we we had generic entry in May. So you know already in may of this.

Konstantin Saroukos: So we're monitoring that, situation.

This year. So we are monitoring that situation said, we've had seven generics that have already entered into the market in the U S. We also expect another 10 generics coming in in the coming weeks. So obviously this is something that we have factored into our forecast for the full year, but we'll continue to monitor them hopefully.

Konstantin Saroukos: We have seven generics that have already entered into the market in the US. We also expect another 10 generics coming in, in the coming weeks.

Konstantin Saroukos: So obviously, this is something, that we have factored into our forecast for the full year, but we'll continue to monitor and hopefully, you know, quarter two will be another strong quarter.

Konstantin Saroukos: And we can perhaps come back to you and update you accordingly there for the full year guidance.

Konstantin Saroukos: Thank you very much.

unknown: Thank you very much.

Quarter, two will be another strong quarter, and we can perhaps come back to you and update you accordingly.

Andy Plump: And Yamaguchi-san, this is Andy.

unknown: So we discontinued TAC-994 because of drug-induced liver injury signal, that we don't believe is class-related or mechanism-based but molecule-related.

unknown: TAC-861 is a unique molecule with a very different profile to TAC-994.

unknown: It's a much more potent molecule and it has a very different exposure profile.

unknown: So part of what we're doing in the context of our phase one studies is we're trying to understand what the overall profile of TAC-861 and whether it's going to have an efficacy and safety profile that's going to be distinct from TAC-994.

You got it thank you very much.

Thank you very much for your question on OO3.

unknown: And that will be what will drive the go-no-go decision into phase two.

And Yamaguchi San this is this is Andy. Thank you very much for your question on <unk> three and <unk>.

Andy Plump: And I think you essentially answered your own question.

unknown: Thank you so much.

You essentially answered your own question.

So just to remind everybody we submitted the original dossier to the special track in the EU called EU medicines for all and it's a process whereby.

Countries outside of the U can actually leverage the opinion, if they if they choose they can leverage the opinion from the EU. So it allows the medicine to be made available well beyond the EMEA countries.

Andy Plump: So just to remind everybody, we submitted the original dossier to the special track in the EU called EU Medicines for All.

We filed initially based on a three year dataset.

And as we were engaging in discussions with the EMA. We made the decision to pause the file and include our four and a half year data set and as you saw from the data we presented today.

<unk> has been out in the public domain that four and a half year data look quite.

Quite remarkable and continue to support the overall benefit risk profile of the vaccine. So we've now submitted those data and we're going through a process of discussions ongoing discussions with EU and we expect to have a C. H M. M P opinion, and hopefully a positive decision.

Andy Plump: And it's a process whereby countries outside of the EU can actually leverage the opinion, if they choose, they can leverage the opinion from the EU.

Later later this year.

unknown: ありがとうございました

Yeah.

Thank you.

So I think that's always I must stop.

So you can of course small.

And what I still cannot cool things come up.

Andy Plump: So it allows the medicine to be made available well beyond the EMA countries.

I mean with all kinds of still haunt us good that's fine.

Andy Plump: We filed initially based on our three year data set.

Hello This is a.

And the more Tokyo Cannon Chairman, yes, we can hear about hat. So thanks for taking my questions I have two questions. If I may one is about entyvio. So when we look at the competitive landscape for IBD seems like there'll be a lot of new entrants in the next two years. There has been work I think there is skiba you receive approval for Crohn's disease June and within the next three years, there will be sky.

As an ultrasonic ulcerative colitis, I think miracles, Michael maybe launching in ulcerative colitis, It's Russell from Pfizer, So I understand that none of these drugs have really demonstrated a clear advantage over entyvio in terms of clinical remission, endoscopic remission or things that actually matter and I E. I also understand that none of these new entrants are going to report head to head with.

Yourself versus Humira like what <unk> did with diversity trial. So we're relatively confident that entyvio will maintain growth, but is takeda worried about entyvio growth, possibly slowing down in the 'twenty three 'twenty four time frame when <unk> is one that's.

That's the first question.

The second question is about the pipeline.

Specifically muraoka, plus sulfur and citizens that because I'm curious if these both of these drugs in bulk interferon.

They're very interesting.

A couple of spots, where there's a trial for combination therapy with keytruda in solid tumors, specifically normal. It says the the trial ends in 2000 and since August .

Since interferon is likely to strengthen PD one activity, if we see any or are in primary PD. One resistant melanoma, we looked up be considered POC why this isn't just listed on page 10 or 11.

For some citizens I assume you'll be seeing results in MSS CRC first and then S. Yossi and cervical cancer later I couldnt find much scientific evidence corroborating the involvement of interference specifically in MSS CRC, how confident is takeda in showing activity in this very difficult those are.

Andy Plump: And as we were engaging in discussions with the EMA, we made the decision to pause the file and include our four and a half year data set. And as you saw from the data we presented today, and as has been out in the public domain, the four and a half year data look quite remarkable and continue to support the overall benefit risk profile of the vaccine.

Andy Plump: So we've now submitted those data, and we're going through a process of discussions, ongoing discussions with the EU.

Two questions.

Andy Plump: And we expect to have a CHAMP opinion and hopefully a positive decision later this year.

Andy Plump: Thank you.

Thank you very much for the question, it's crystal clear.

You knew whether the IBD market view.

<unk> has established a very strong track record of.

Of efficacy and safety since its launch for more than seven years ago.

We have an established pursue a superiority against <unk> and the TNF Alpha class still has a very significant.

Market share in this market. So is there is a lot to do and today, we are a leading truly leading you.

We are the leading therapy of choice for bio naive patient. So we are very much aware of the competition, it's a very dynamic market.

But we believe that on TV, who is extremely well positioned we have not seen them.

<unk> product, which has any.

Demonstration of superiority so yes, it would be more competition, but this is also.

A disease, where there is a lot of churn among treatment.

Still a lot to do to to continue to establish the best based on our scale, which you don't see it here today. When do you think that the <unk> has a very significant market share in this in this market so very confident about them to view.

We also plan to launch a subcutaneous formulation in the U S in the coming year that will either.

A more dynamic also to the product so very confident about the continued growth will continue in the future.

And could that Qahtani. Thank you very much for the questions about medaka first Boston Super some stats.

You mentioned these are both agents that work at least in part two and interferon Alpha based mechanism.

And our representative really up our oncology strategy to focus on innate immune mechanisms.

Firstly from a doctor first alpha our focus right now is really on.

In melanoma, where we've seen very compelling evidence of clinical activity in highly refractory patients and so our focus for <unk> is in building out that.

That profile in refractory patients and also moving up and lines of therapy through combination therapies and so we'll be starting over the course of the next few months combination initially.

Dara tumor map and then with other agents the studies that you're mentioning in in solid tumors are still quite.

Quite exploratory we're still in the process of understanding.

Dose safety profile. So we've been hesitant to define a date for when we might have POC, because we're still working through.

We're still working through a number of issues with their sectors Superstorm stat, which is.

I'm also really exciting mechanism that works at least in part through interferon Alpha signaling and we published quite extensively on the translational data that we've seen in humans in terms of immune activation with this mechanism.

Our challenge has been understanding where exactly to target into what tumor and so we're looking across a range of different tumor types.

The three that are.

Most actively enrolling right now or combination studies on top of PD one inhibitors. The first is in.

<unk> satellite stable colorectal cancer. We're also looking at non small cell lung cancer and of course in melanoma. The first datasets that we'll have readout will be in the microsatellite stable colorectal population.

Incredibly challenging population to see benefits in.

So so we'll wait and see what that data set looks like we actually had some.

I'm partial responses in a phase one phase III study, which is the you asked about rationale that was the rationale for proceeding in app and that difficult population I think our focus given the biology will be more on the melanoma and non small cell lung cancer populations.

Andy Plump: Yamaguchi-san, arigatou gozaimashita.

Thank you very much.

Gold by signing up all those I must stop your lots as they cannot smaller.

And now he already signed.

We had all kinds of still have muscular fight.

Hello, everyone and thank you so much for for taking our question.

So just a couple of an hour and.

Maybe starting with deposits.

The positive <unk> results in CIP.

Could you discuss the total opportunity and growth prospects in the immunoglobulin for immunoglobulin and the space.

Especially in light with yourselves, so Keith is central.

And just in general how do you see the market being segmented and improve over time.

The second one is on the Arrowhead collaboration.

We noticed that the phase two placebo controlled study results are expected sometime in the fall client. According to clinical trials on calls do you expect to present these results at our.

Academic conference and can you just walk us through the next steps towards regulatory filing.

And the opportunity here. Thank you so much.

Thank you very much.

It's Christophe here.

Okay.

<unk>.

The.

The immunoglobulin Selwyn noted for to treat J D piece of this is this is not a new.

Such a treatment with what is new in the case of <unk>. So it's a.

One of the most.

Convention.

Okay.

And we believe that that will really help the patients too.

To without treatment and and we don't have any indication of CDP in the U S.

We don't have it for <unk> as well as slow so too we believe that nevertheless, our products are used but we never had the indication. So I think it's really great for us first to be able to have this to file this indication for <unk>.

And again, our TVA is a very competitive.

The device is a very competitive formulation very convenient for for patients. So we think that the efficacy combined with just convenience will will will.

We'll be a big add another big plus for your patience.

<unk> overall net.

We remind you that overall the tid indication represent about 20% of the <unk>.

Overall immunoglobulin market.

Globally.

And on the is as Andy Kyrgyzstan on the Arrowhead.

99 nine question.

So just just again to remind you we just the data that we've seen so far in the open label study ongoing open label study has been just so remarkable in terms of the.

Percent knockdown, we're seeing 90% knockdown of the mutant Alpha one antitrypsin RNA, we're seeing almost 85% knockdown of the mutant protein aggregate, we're seeing trends towards reductions in liver function tests and on biopsy again non.

Trolled setting, but we're seeing actually a regression in fibrosis over a very short time periods of 24, and 48 weeks and so the data that we've seen to date are compelling enough to drive a go decision for a pivotal study.

The placebo controlled blinded phase II data that will be coming out later this year of course that those data will be presented at the Congress, but it's important to note that those that study is being run by our collaborator Arrowhead. So there'll be responsible for that presentation I think that data set will be important and.

In helping us further understand the overall profile of the molecule, but we believe based on the data that we've seen so far that we have enough compelling evidence to move forward.

We strongly believe.

That we're going to need a full phase III study two for approvals and what our hope is that we'll be starting that phase III study.

This year the <unk>.

Specific endpoints, where that study we're in the process of discussing those with with FDA and other agencies.

Ayako Iwamura: Soredewa, tsuzuite no go shitsumon wa, Nomura shouken no Kotani-sama.

Thank you so much very helpful and congratulations.

Kotani Nomura: Mute wo kaijou shite ohanashi kudasai.

And you've got the all cause I must stop.

So they've got lots of weekend of course smaller JP models also cannot look I'll sum up with all kinds of stuff on escrow to fight.

Hello, this is Kotani Nomura from Tokyo.

Hi, Jeff.

One of the oldest search whenever I Smiths.

May God to shove them Cook says are you on a game.

Dennis.

Thank the horse quota credit taken across the board anchor itself, how do they stay on the shelf.

Mobile phone calls messenger liked up.

Horseshoe Governor tagging.

Hi, Dan like Tomorrow.

No additional cost.

Right.

Okay.

So I say the horse shoe, that's going to take it in a while the kickoff, bringing convincingly Kamala specific cross site there.

Scott the Mega hung currency constant.

To call out one of our support that hung price you got asked and answered.

That's it.

But he is showing them our consolidated theater ensure they say Hong Kong pick up off of that portfolio.

Did you guys see it in the scar, although part of both the Norfolk definition to fulfillment.

One additional thought.

Second or third quarter.

And then they've got to be made at the vehicle at the one of the stuff.

On a faster path I know you've got an article on the fourth day cohorts is get avocado cost.

Finally class they negotiate the cost right.

Yes.

Yeah.

Thank you Brad. Thank you very much with Carlson for your question now on the first one on the PDP reduction and we personally don't disclose margins, but what I can say is that the reduction in the donor fees has been factored into our full year guidance.

So that's one thing on the on the SG&A controls Youre right on the we have seen a reduction overall SG&A predominantly driven by the investments that we've done in the past and currently on data digital and technology.

In respect to sales and marketing, where we're leveraging data digital technology in particular around omnichannel targeting with physicians et cetera, and only on the G&A side, we're seeing some significant savings coming through again, leveraging data digital technology automation and leveraging up tick.

Business solution centers, where we are increasing the number of back office transactional activity in particular around hey.

Our procurement and finance and that's helping overall improved productivity and efficiency. So we're very pleased with the progress there and we'll continue to manage these moving forward.

Kotani Nomura: Can you hear me?

Thank you for your question.

Okay.

Alright.

Yeah.

Look I'll phone and he got all of US I must stop.

Yeah that sounds like they are of course smaller die us how can I forget some of them.

With all kinds of still haunt us good eyesight.

I'm sure. It's the best way I think that's all the time as a first of all my stuff with us.

The eruption.

There are therefore goes up on the Silicon circuit at <unk>.

So first off top of my basket at all it's all about the local mother.

The top panel cartoon on slide five I thought.

Yes, we can hear you.

I mean first of all household for them or without Robert can answer it off I come up today to talk to you about a lot of that additional time is all of this.

Okay.

Kotani Nomura: Go ahead.

Thank you very much Husky Gucci Sun, it's costa here.

Revenue for the first quarter was $19 4 billion yen, which is a combination of both spike that backs and <unk> at this stage, we are holding on the target of the 50 Big again, so no further update at this stage, but we're we're.

Kotani Nomura: So thanks for taking my questions.

Kotani Nomura: I have two questions, if I may.

Kotani Nomura: One is about Antibiotics.

Kotani Nomura: So when we look at the competitive landscape for IBD, it seems like there will be a lot of new entrants in the next two years.

Kotani Nomura: There's Rimbach.

Kotani Nomura: I think there's Skyrizy received approval for Crohn's disease in June.

Kotani Nomura: And within the next two years, there will be Skyrizy in ulcerative colitis.

Kotani Nomura: I think Mirakizuma from Lilly launching ulcerative colitis.

Kotani Nomura: Atrazumab from Pfizer.

Kotani Nomura: I also understand that none of these new entrants are going to report head-to-head results versus Humira, like what Antibio did with VERSITY trial.

Kotani Nomura: I understand that none of these drugs have really demonstrated a clear advantage over Antibio in terms of clinical remission or endoscopic remission or things that actually matter in IBD.

We're very happy.

Happy with the start of the fiscal year. So that's where we're tracking $19 4 billion for Q1, and we're maintaining the guidance at 50 billion yen for the full year.

Kotani Nomura: So we're relatively confident that Antibio will maintain growth.

Thank you.

Yeah.

I have to stop.

That's a good sign and you got all of US I must stop.

Kotani Nomura: But is Takeda worried about Antibio growth possibly slowing down in the 23 to 24 time frame when VIVAS is going off?

So that there are lots of zinc and of course smaller glad he says the silicon not helped by some of the adult kinds of sales on us Goodbye.

And all this is speaking who because of this.

So two questions.

Kind of retail activity.

Activity.

The fourth quarter seems to be a.

It will be lower than we're updating our expectations and what we're going to see the spike.

The trend.

Going forward now you mentioned about important indications for both drugs.

Thats the BLA, so what what is going to be trigger or.

Kotani Nomura: That's the first question.

The cyclone Shepherd.

Sales trends for these two important.

Kotani Nomura: The second question is about the pipeline.

Kotani Nomura: Specifically, Modaka-Posfalfa and Subazumab.

The important news.

Products. So that's the first question.

Question is up at six one.

<unk>.

I.

If I'm not mistaken you are going to.

Have the readout of the phase one data sometime in August .

And once you find a new well if it's a good result.

Sure.

Got you.

What is your plan to disclose.

Kotani Nomura: Curiously, both of these drugs involve interferon.

Uh huh.

The outcome of this Uh huh.

Doug.

Mike Good question. Thank you.

Kotani Nomura: And they're very interesting.

Thank you.

Kotani Nomura: For Modaka-Posfalfa, there's a trial for combination therapy with Keytruda in solid tumors, specifically melanoma.

It's Christophe here.

So I think we are we are not disappointed at all by the Q1 actually.

Kotani Nomura: It says the trial ends in 2023 August.

Kotani Nomura: Since interferon is likely to strengthen PD-1 activity, if we see any ORR in primary PD-1 resistant melanoma, wouldn't that be considered POC?

We are very pleased with the uptake.

Kotani Nomura: Why isn't this listed on page 10 or 11?

You know you need to when you launch a product like Crystal City first read too.

Kotani Nomura: For Subazumab, I assume we'll be seeing results in MSSCRC first and then NSCRC and cervical cancer later.

I have the product reference in the deferment of the transplant Center.

We have a chip that very very well.

The majority of the transplant center are now referring to as density and.

56% of the 314 transplant center in the U S have already usage. So it will take a while to translate that into revenue, but it will happen.

Kotani Nomura: I couldn't find much scientific evidence to corroborate the involvement of interferon specifically in MSSCRC.

Kotani Nomura: How confident is Takeda in showing activity in this very difficult subset?

Then of course, the first line is a key here.

The majority of the value will be in the first line indications, which you will see it starting next year and the year.

Kotani Nomura: Those are the two questions.

So so thats left on <unk>.

Kotani Nomura: Thank you.

Keep in mind also that <unk> overall potential revenue potential is higher than <unk>.

Christophe Weber: Thank you very much for the question.

Women and.

And on excuse me Ts if.

So also as their first line is also very critical.

As a first line indication.

So very critical disease, where there is a high dose.

Market values too I think this product will be successful.

We.

As an early sign a very strong like this to product we'd be very a successful we just need to have the full set of indication to translate that into revenue per controller.

Christophe Weber: It's Christophe here.

And secondly on Tac 861.

Christophe Weber: I think you know well the IBD market.

Just to be clear and I am sorry, if there was a miss understanding.

Christophe Weber: Antivu has established a very strong track record of efficacy and safety since its launch more than seven years ago.

Christophe Weber: We have established also superiority against TNF-alpha.

We will not have a dataset that will enable us to make a decision a go no go decision in August .

So we what we've disclosed is that we will have a decision to go no go decision by the end of this year.

So just so that we're clear in terms of timelines.

So at the end of this year.

No that's right and that's I think what we've been guiding all along you know nothing nothing has changed since we have since we made the transition from 90 94861 in terms of our acceleration.

Data set that will enable this trend.

This decision will be healthy volunteer sleep deprived data and then also type one narcolepsy patients treated for a month. So we're in the process of accumulating that blinded data set now.

Christophe Weber: And the TNF-alpha class still has a very significant market share in this market, so there is still a lot to do.

Okay. Thank you.

Christophe Weber: And today we have a leading therapy of choice for bio-naive patients.

Hi, Tom I didn't I thought was I must stop.

Christophe Weber: So we are very much aware of the competition.

Christophe Weber: It's a very dynamic market.

Zinc and Argos smaller quota temasek still cannot.

Okay, just that well have to ask if that's right.

Christophe Weber: But we believe that Antivu is extremely well positioned.

Christophe Weber: We have not seen a product which has any demonstration of superiority.

Hi can you hear me.

Hi, it's quite early Miss it.

Thank you for taking my questions.

Oh one question.

Christophe Weber: So yes, there will be more competition, but this is also a disease where there is a lot of churn among treatment.

Christophe Weber: But still a lot to do to continue to establish the best standard of care, which is Antivu today.

Question on for the rest of your franchise.

Company decided the discontinuation of the development up 94 based on the clinical data. So could you share your thoughts on the Fox <unk> behind the Brockman suspension for the top 99, Paul and Oh, whether you know you think are the Fox will affect the safety profile of <unk> eight.

Christophe Weber: When you think that the TNF-alpha class still has a very significant market share in this market.

Six alone I think.

Christophe Weber: So very confident about Antivu.

Christophe Weber: We also plan to launch a continuous formulation in the U.S. in the coming years that will add more dynamic also to the product.

Christophe Weber: So very confident about the continuous growth of Antivu in the future.

Thank you very much so we discontinued.

99, four because of drug induced liver injury signal that we don't believe is class related or mechanism based per molecule related.

<unk> is a.

Unique molecule with a very.

Different profile to tech 99 for at a much more potent molecule and it has a very different exposure profile. So.

Part of what we're doing in the context of our phase one studies as we're trying to understand.

And what the overall profile of tack, a six one and whether it's going to have.

Andy Plump: And Kotani-san, thank you very much for the questions about Modaka-Fospalfa and Supathumstead.

Andy Plump: And as you mentioned, these are both agents that work at least in part through an interferon, alpha based mechanism and are representative really of our oncology strategy to focus on innate immune mechanisms.

<unk> efficacy and safety profile, that's going to be distinct from Tac 994, and that will be what will drive. The go no go decision into phase two.

Andy Plump: Specifically for Modaka-Fospalfa, our focus right now is really on melanoma, where we've, seen very compelling evidence of clinical activity in highly refractory patients.

Andy Plump: And so our focus for Modaka-Fosp is in building out that profile in refractory patients and, also moving up in lines of therapy through combination therapies.

Andy Plump: And so we'll be starting over the course of the next few months, combination trials initially, with daratumumab and then with other agents.

Andy Plump: The studies that you're mentioning in solid tumors are still quite exploratory.

Andy Plump: We're still in the process of understanding dose safety profile. So we've been hesitant to define a date for when we might have PFC because we're still, working through, you know, we're still working through a number of issues.

Andy Plump: With Resectus subistamstat, which is also a really exciting mechanism that works at, least in part through interferon alpha signaling, and we've published quite extensively on the translational data that we've seen in humans in terms of immune activation with this mechanism, our challenge has been understanding where exactly to target and to what tumor.

Andy Plump: And so we're looking across a range of different tumor types.

Andy Plump: The three that are most actively enrolling right now are combination studies on top of, PD-1 inhibitors.

Andy Plump: The first is in microsatellite-stable colorectal cancer.

Okay. Thank you so much.

Andy Plump: We're also looking in non-multicellular lung cancer and, of course, in melanoma.

Andy Plump: The first data set that we'll have read out will be in the microsatellite-stable colorectal, population.

Okay.

Andy Plump: It's an incredibly challenging population to see benefits in.

Andy Plump: So we'll wait and see what that data set looks like.

So you've got all the famous stop.

Andy Plump: We actually had some partial responses in our phase one, phase two study, which is the, – you asked about rationale. That was the rationale for proceeding in that difficult population.

Andy Plump: I think our focus, given the biology, will be more on the melanoma and non-small-cell, lung cancer populations.

Andy Plump: Thank you very much.

So that the law.

unknown: Hello, everyone.

unknown: Thank you so much for taking our question.

So you don't know, what's your kind of thought that even though some of that is on what's your mustache wanted to know maybe now see also for fergie, though that that concerns us.

unknown: So, just a couple on our end, maybe starting with the positive IQVIA results in CIDP, could, you discuss the total opportunity and growth prospects in the immunoglobulin – for immunoglobulins in the space?

unknown: Especially in light with CSL's subcutaneous entro and just in general, how do you see, the market being segmented and evolved over time?

unknown: And the second one is on the Arrowhead collaboration.

unknown: I'm not sure if you can see it, but the Arrowhead collaboration is a collaboration, between the American Institute of Health Sciences and the American Institute of Health Sciences, And the second one is on the Arrowhead collaboration.

unknown: We noticed that the phase two placebo-controlled study results are expected sometime in the, fall according to clinicaltrials.gov.

unknown: Do you expect to present these results at an academic conference?

unknown: And can you just walk us through the next steps towards regulatory filing and the opportunity, here?

unknown: Thank you so much.

Okay.

That's all he thought that the company had he got thought was I must stop.

Got that.

Yes, I know.

Thank you Sandy Costa Atlantica Overman, our bylaw.

I got a phone call kind of when you're going to end up where he got lucky myself that our school and they got them or selling them off.

Christophe Weber: Thank you very much, Georges.

Christophe Weber: It's Christophe here.

Christophe Weber: Look, the immunoglobulins are well known to treat CIDP, so this is not new as such a treatment.

It's not a phone call with other key nakatani I need I thought was I must not so that's the source of data that attackers aren't enough.

Christophe Weber: But what is new in the case of IQVI is that it's one of the most convenient subcontinuous formulations.

And he got the all of US I must stop.

Thanks, everyone Bye for now.

Okay.