Q2 2024 Takeda Pharmaceutical Co Ltd Earnings Call
Speaker 1: transcript
Speaker 1: Thank you for your attention.
Thank you very much. I am Yuri Ora, the IR head, and I will be your host today. Thank you for joining us. First, let me explain the language settings. There is a language button at the bottom of the Zoom window. If you would like to listen in Japanese, please select Japanese. If you would like to listen in English, please select English. If you prefer to listen to the original audio, please turn it off. In today's call, we will be discussing forward-looking information as defined by the U.S. Private Securities Litigation Reform Act of 1995. Please be aware that actual results may differ significantly from those discussed today. Factors that could cause actual results to differ materially are described in our latest Form 20-F and other filings with the SEC. Additionally, we may discuss financial measures that do not conform to international accounting standards. Please refer to the appendix of the presentation for definitions and reconciliation tables of these measures. Please also review the important notes on page 2 of today's presentation materials. Now, let's move on to today's presentation. Presentations will be given by President and CEO Christophe Weber, R&D President Andy Plump, and Chief Financial Officer Costa Saroukos. After that, we will have a Q&A session. Let's get started. Christophe, please. Christophe: Thank you, Chris. Thank you for joining us today. It is truly an honor to meet with all of you. At Takeda, our goal is to discover ways to transform lives and to lead patients, people, and the planet. Our approach to this purpose is to focus on long-term value creation, which is at the core of our strategy for our stakeholders. We are rapidly transforming all functions of the company using data, technology, and AI. This year, we will provide more details on this remarkable transformation. During the first half of 2023, we have shown significant achievements in two strategic areas of our pipeline. We are maximizing our portfolio, advancing our pipeline, and delivering on our commitments. Moving on to slide 5, we will discuss the strength of our core business and our ability to deliver life-changing treatments to communities and patients. Looking at our financial results, our revenue for the period was 2.1 trillion yen, or 14.1 billion dollars. Year-over-year, the increase at constant exchange rates was 1.4%. Driven by the growth of our development products, our total amount increased by 42%, and at constant exchange rates, it rose by 13%. At actual exchange rates, our top-line growth was 6.4%. This top-line growth extends beyond our algorithm.
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Speaker 1: transcript
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Speaker 1: transcript
Speaker 1: Thank you for your attention.
Speaker 1: transcript
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Speaker 1: transcript
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Speaker 2: transcript
Speaker 2: Thank you, Chris. Thank you, everyone, for joining us today. It's a real pleasure to be with you all.
Thank you Chris. Thank you everyone for joining us today, it's a real pleasure to be with you.
Speaker 2: transcript
Speaker 2: At Takeda, our vision is to discover and deliver life transforming treatments guided by our commitment to patients, our people and the planet.
Takeda our vision is to discover and deliver life transforming treatment guided by our commitment to patients our people on the planet.
Speaker 2: transcript
Speaker 2: This purpose-led approach is at the core of our strategy to deliver long-term value creation for our stakeholders.
This proposal led approach is at the core of our strategy to deliver long term value creation for our stakeholders.
Speaker 2: transcript
Speaker 2: We are rapidly embracing the use of data, technology, and AI, transforming the company across all functions. We'll provide more details on this remark.
We are rapidly embracing their use of desktop particular, G&A AI transforming as a company across all functions.
We'll provide more details on this remarkable change next year.
Speaker 2: transcript
Speaker 2: Our performance in the first half of fiscal year 2023, while facing two setbacks with our pipeline, further demonstrates our progress in executing on our strategy as we look to maximize our portfolio, advance our pipeline and deliver on our commitment.
Our performance in the first half of fiscal year 2023, while fishing two setbacks with our pipeline further demonstrate our progress in executing on our strategy as we look to maximize our portfolio advance our pipeline and deliver on our commitments.
Yeah.
Speaker 2: transcript
Speaker 2: Turning to slide five. Our first semester performance underscores this trend for our core business and our ability to deliver live transforming treatment to patients on communities.
Turning to slide five.
Our first semester performance underscores the strength of our core business and our ability to deliver life transforming treatment to patients and communities looking.
Speaker 2: transcript
Speaker 2: Looking at our financial results, revenue for the period was 2.1 trillion yen, or 14.1 billion US dollars.
Looking at our financial results revenue for the period was $2, one trillion yen or $14 1 billion used at all.
Speaker 2: transcript
Speaker 2: Year-over-year growth at a constant exchange rate was 1.4%, driven by momentum in our growth on launch product, which represents 42% of our total revenue and grew at 13% at a constant exchange rate.
Yeah, well, yeah growth at a constant exchange rate was one 4% driven by momentum in our growth on the ultra product, which represents 42% of our total revenue and grew at 13% at a constant exchange rate.
Speaker 2: transcript
Speaker 2: At actual exchange rate, our top-line growth was plus 6.4%.
Actual exchange rates, our top line growth was plus six 4%.
Speaker 2: transcript
Speaker 2: This top line group is despite generics for violence launching in the US after a patent expiry in August .
This top line growth is just buy generics for vyvanse launching in the U S. After a patent expiring in August two debt to date the impact of generics in Vyvanse market share has been broadly in line with our expectation.
Speaker 2: At present, the impact of the market share of generics and violence is broadly in line with our expectations. The corporate profit was 58.88 billion yen, or 390 million dollars, which decreased compared to 9.5% in the previous year. Compared to the year, it is broadly in line with expectations. This reflects these impacts due to high-margin produce, a decline in demand for coronavirus vaccines, and strategic investments in our R&D technology to ensure long-term competitiveness. The current call EPS was 261 yen. As reported, the impact of profits by call EPS was affected by large non-call items purchased over two months. This included the impact of inappropriate assets regarding Eskiviti and Allofizel. It was very inappropriate for patients and included inappropriate assets for the company. The two setbacks causing the impact of these inappropriate assets are to influence our strategy to provide relatively sustainable prices to contributors in the long term, and we will explain this event in detail later. Let's move on to the reference for the fiscal year. To estimate full-year income and call EPS, we reflect updated amounts and tax rate forecasts. We are sticking to management's instructions for call increases. And there is no change in our instructions. Also, our full-year income forecast remains unchanged at 40 billion yen to 50 billion yen. Based on the report standards, we are lowering the reference amount due to the impact of the full-year income forecast. In slide 6, we provide new treatment methods to improve the quality of life and new patient populations by providing new patient populations. Last month, we received FDA approval for the non-invasive test of the stable health center. The non-invasive test of the stable health center allows patients to choose two types of management through non-invasive testing. The non-invasive test is expected to be released in the United States at the end of October. And we are fully committed to the success of development. The next slide will deliver progress and growth. The FDA is evaluating the management of non-invasive testing. And we expect a decision in the first half of 2024. Our dengue vaccine, SkuDengia, continued significant progress in the fight against dengue fever. Last month, the medical institution of WHO received approval.
Speaker 2: transcript
Speaker 2: To date, the impact of Generix and Vyvanse market share has been broadly in line with our expectations.
Speaker 2: transcript
Speaker 2: Core banking profit was 588.8 billion yen, or 3.9 billion US dollar, with a decline that was prior year of 9.5%
Core operating profit was 588 eight.
8 billion yen are $3 9 billion you missed it all with a decline versus prior year of nine 5%.
Speaker 2: transcript
Speaker 2: The year of area decline is in line with expectation and reflect the impact of loss of exclusivity for higher margin products, lower of coronavirus vaccines demand, as well as our strategic investment in R&D and the town technology to ensure that takedown long term competitiveness. Core IPS.
The year over year decline is in line with expectation and reflects the impact of loss of exclusivity for higher margin products lower corner virus vaccines demand as well as our strategic investments in R&D and technology to ensure that ticket that long term competitiveness.
Core EPS for the period was 261 yet.
Speaker 2: transcript
Speaker 2: On the reported basis, operating profit on EPS were impacted by large non-core item booked in the second quarter, including impairment of intangible assets related to activity and alitché.
On a reported basis operating profit and EPS were impacted by large noncore items booked in the second quarter, including impairment of intangible assets related to <unk> and the Louisiana.
Speaker 2: transcript
Speaker 2: While very unfortunate for patients and material to the company, the two-setbacks triggering this impairments don't impact our strategy for delivering a near-term return to growth and long-term sustainable value for shareholders.
Why are the very unfortunate for patients are material to the company. The two setbacks triggering this impairments don't impact our strategy for delivering a near term return to growth.
And long term sustainable value for shareholders.
Speaker 2: transcript
Speaker 2: Costa will go into this item in more detail later in the presentation.
Of course that will go into these items in more detail later in the presentation.
Turning to the outlook for the remainder of the fiscal year, we are raising full year revenue and core EPS forecast to reflect updated forex and tax rate assumptions.
Speaker 2: transcript
Speaker 2: Turning to the outlook for the reminder of the fiscal year, we are raising full-year revenue on core IPS forecasts to reflect updated forex and tax rate assumptions.
Speaker 2: transcript
Speaker 2: We are on track to our management guidance for core growth at a constant exchange rate, and there is no change to our guidance.
We are on track to our management guidance for core growth at a constant exchange rate and there is no change to our guidance.
Speaker 2: transcript
Speaker 2: There is also no change to our fully free cash flow forecast of 400 to 500 billion yen.
There is also no change to our full year free cash flow forecast of 400 to 500 billion.
Speaker 2: transcript
Speaker 2: On a repotted basis, we are lowering fully a pocket forecast due to the impact of the non-correct ambush in the second quarter.
On a reported basis, we are lowering full year pocket forecast due to the impact of the noncore items booked in the second quarter.
On slide six.
Speaker 2: transcript
Speaker 2: We are advancing our innovative portfolio to reach new patient population, address and meet needs and provide new treatment options to improve patient outcome and quality of.
We are advancing our innovative portfolio to reach new patient population address unmet needs and provide new treatment options to improve patient outcome and quality of life.
Speaker 2: transcript
Speaker 2: Last month, we received the approval for the continuous administration of ONT-EVO for maintenance therapy in moderate to severely active seritis collages.
Last month, we received FDA approval for the soup continuous administration of <unk> for maintenance therapy in moderate to severely active accelerated colitis.
Speaker 2: transcript
Speaker 2: This makes an interview the only FDA approved biologics in eucaryotic colitis and author patients the choice of two types of administration.
This makes MTV, we're the only FDA approved biologics in your side keep colitis and hotel patient a choice of two type of administration.
Speaker 2: transcript
Speaker 2: We expect on TV OSF QtNLs to be available in the US by the end of October , and we are fully committed to the success of its launch. I will come back to interview progress and growth, I'll talk on the next slide.
We expect on television subcutaneous to be available in the U S. By the end of October and we are fully committed to the success of its launch.
I will come back going to give you a progress on growth outlook on the next slide.
Speaker 2: transcript
Speaker 2: Yavier is also evaluating our application for sub-continuous administration of anti-view for the treatment of Crohn disease.
<unk> is also evaluating our application for soup continuous administration of Hunter you view for the treatment of Crohn's disease and.
Speaker 2: transcript
Speaker 2: And we expect a decision in the first half of fiscal year 2012.
And we expect a decision in the first half of fiscal year 2024.
How do you keep X gene's Katanga continues to be recognized as a critical step for what in the fight against dengue fever.
Speaker 2: transcript
Speaker 2: Our Dengue vaccine, Spudengue, continues to be recognized as a critical step for one in the fight against Dengue fever.
Speaker 2: transcript
Speaker 2: Last month, the WHO's strategic advisory group of experts on immunization recommended its use in high-dengue burden on transmission areas for children age six to 16, where it believed the vaccines will have the greatest public health impact.
Last month, the superior choice strategy Advisory group of expert on immunization recommended its using the high dengue burden in transmission areas for children age six to 16, where it believes the vaccines would have the greatest public health impact.
Speaker 2: Additionally, the approval in the first half of this year aims to provide the first COVID-19 product in Japan, satisfying our elderly customers. In our oncology portfolio, Atetris received approval as the first measure for stage 3 customers with Hodgkin's lymphoma. The approval is based on the positive overall survival results of the phase 3 Echelon 1 study, showing significant improvement in stage 3 and stage 4 Hodgkin's lymphoma over two years. Next, looking at the slide on the right, we see our progress with COVID-19. We have resubmitted TAC721 to the USFDA for eosinophilic treatment of azafagitis. We expect a decision from the FDA in the first half of the 2024 calendar year. Additionally, we announced positive topline results from the phase 2B trial of TAC279 for active psoriatic arthritis. This is a significant advancement in developing new treatment methods for COVID-19 patients. We received several filings in Japan in the first half. We received filings for metastatic coronavirus cancer and TAC755. We are proud to have received a specific licensing agreement with Immunogen. In Japan, we developed, marketed, and developed Miyatobitokimab for FR?-positive ovarian cancer. We also received positive topline results for active psoriatic arthritis. We received positive topline results for active psoriatic arthritis. We received positive topline results for active psoriatic arthritis. We received positive topline results for active psoriatic arthritis.
Speaker 2: transcript
Speaker 2: Although my soon in the first half of the year, I include a pool of QB through as our first subcutaneous immunoglobulin product in Japan, delivering on our commitment to reach patients with high and medium.
Well, it's a milestone in the first half of the year and through the approval of could be true as our first ship with the newest immunoglobulin products in Japan, delivering on our commitment to reach patients with high unmet needs.
Speaker 2: transcript
Speaker 2: And in our oncology portfolio, Atitrice received a label extension in Europe for stage three patients as a first line treatment for ochskin lymphoma.
I only know oncology portfolio as interest received a label extension in Europe for stage III patients as a first line treatment for skin lymphoma.
The approval was based on updated positive overall survival results from the phase III echelon. One study for stage three and four are just getting lymphoma, which demonstrated the first significant improvement in overall survival in two decades in stage, three and four which skin lymphoma.
Speaker 2: transcript
Speaker 2: The approval was based on updated positive overall survival results from the Phase III echelon I study for Stage III and IV or Skin Limformer, which demonstrated the first significant improvement in overall survival in two decades in Stage III and IV or Skin Limformer.
Moving to the right side of the slide to look at progress in our innovative pipeline.
Speaker 2: transcript
Speaker 2: Moving to the right side of the slide to look at progress in our innovative pipeline.
Speaker 2: transcript
Speaker 2: In September , we resubmitted TAC721 to the US FDA for the treatment for eosinophilic esophagitis.
In September we resubmitted Tak seven to one to the U S. FDA for the treatment for it it wasn't a fatigue is it for <unk>.
Speaker 2: transcript
Speaker 2: We expect a decision from the FDA during the first half of calendar year 2024.
We expect a decision from the FDA during the first half of calendar year 2024.
Speaker 2: transcript
Speaker 2: Also in September , we announced positive stop line results from our phase 2B trial of them.
Also in September we announced positive topline results from our phase II trial of <unk> 2794, active Psoriatic arthritis, you see the.
Speaker 2: transcript
Speaker 2: This is a significant milestone in our effort to develop a new treatment option for patients with debilitating conditions.
A significant milestone in our effort to develop a new treatment option for patients with this debilitating condition.
Speaker 2: transcript
Speaker 2: We had a number of filings in Japan in the first half with procutinib filed for previously treated metastatic colorectal cancer and TAC755 filed for CTD.
We had a number of fighting in Japan in the first half with continued filed for previously treated metastatic colorectal cancer and Tak 7555 for CGP.
Speaker 2: transcript
Speaker 2: We are pleased to have entered an exclusive licensing agreement with Immunogen to develop and commercialize miavituximab for FR-alpha positive ovarian cancer in Japan.
We are pleased to have entered an exclusive licensing arrangement agreement with immunogen to develop and commercialize it yeah it'd be tricksy Madden for Fr Alpha positive ovarian cancer in Japan.
Speaker 2: transcript
Speaker 2: But we also faced some headwinds. In October , we made the voluntary decision to withdraw exchevitee in the US.
But we also faced some headwinds in October we made the voluntary decision to withdraw its keep it teams of U S.
Speaker 2: transcript
Speaker 2: based on the outcome of the XCAM 2 CONSERMATREED trial and discussion with the ABS.
Based on the outcome of the Exclaim, two confirmatory trial and discussion with the FDA.
Speaker 2: transcript
Speaker 2: We are discussing next steps with regulators in other countries where activity is available as we intend to initiate voluntary withdrawal globally.
We are discussing next steps with regulators in all the countries, where excuse me tease available as we intend to initiate voluntary withdrawal globally.
Speaker 2: transcript
Patients out of poverty and excuse me T remains available to be prescribing Jewish while we work with the FDA to formally withdraw with in an appropriate timeframe.
The withdrawal decision on timeline outside of the U S will vary by country.
Speaker 2: transcript
Speaker 2: The withdrawal decision on timeline outside of the US will vary by country.
Speaker 2: transcript
Speaker 2: Also in October , we announced that the Phase III admired CD2 study of alophysel for the treatment of complex, crointrional fistula did not meet its primary end point.
Also in October we announced that the phase III admire C. D. Two study of <unk> for the treatment of complex crawling through Enel fistula did not meet its primary endpoint.
Speaker 2: transcript
Speaker 2: The study was designed to support the filing in the US and we are currently evaluating next.
This is the study was designed to support a filing in the U S. And we are currently evaluating next steps.
Speaker 2: transcript
Speaker 2: Importantly, the safety profile was consistent with prior studies, and there were no new safety signal identifiers.
Importantly, the safety profile was consistent with prior studies and there were no new safety signal identified.
Speaker 2: transcript
Speaker 2: This event highlight the inherent risk in research and development, but as a company focused on delivering lactron-forming treatment to patients, we must continue to challenge ourselves at the forefront of innovation.
These events highlight the inherent risk in research and development, but as a company focused on delivering life transforming treatment to patients. We must continue to challenge ourselves at the forefront of innovation.
Speaker 2: transcript
Speaker 2: Andy will speak further about our pipeline later in the presentation. Turning now to
And he will speak further about our pipeline later in the presentation.
Turning now to achieve your growth and outlook on slide seven.
Speaker 2: In the first half of 2023, Antiview saw a global increase in sales and continued progress in growth. Antiview excels in having the most influenza patients nationwide and also in new invader therapies. The amplification of invaders in Europe was about 15%, which was able to drive the overall advanced therapy market for invaders. In America, the market for invaders is growing, but the advanced therapy invaders have decreased compared to between 2016 and 2019. The new invaders have not yet returned to pre-COVID levels. However, most excellent patients are not undergoing untreatable or ordinary therapy. Therefore, our business mechanism continues to see great opportunities to expand our leadership in this field. Next, let's move to the slide on the right. It is a catalyst for long-term growth. The approval of maintenance therapy for untreatable management of inulcerative colitis was a major milestone. Antiview is the only FDA-approved biological inulcerative colitis treatment, allowing patients to choose between two types of management. Untreatable is believed to represent about 35% to 40% of the entire invader market. The milestone of accessing this new market is very important. Antiview Pen is expected to be launched in America by the end of October, and we are fully committed to the success of the launch. The FDA is evaluating an application regarding coronavirus for untreatable. A decision is expected later this fiscal year. Through research on coronavirus for untreatable, we are advancing new life cycle management, strengthening long-term growth, solidifying untreatable treatment, and advancing new research. We are investigating the potential of combination therapy for untreatable, disrupting effective treatments with Medrozemab as a background, and specialists and patients in untreatable continue to see the benefits and value of Antiview providing untreatable. We have a peak revenue forecast of $750 million to $900 million, with the timing of forecasts for untreatable unchanged until 2032. Slide 8. Kyudenka is recognized as a major development in the war against untreatable. We aim for strong initial demand in the endemic domestic private market and strong launches in the European travel market. The official vaccination program has not yet started. Kyudenka has been approved in endemic domestic dengue, Indonesia, Brazil, Thailand, and recently in Colombia. We expect it to be launched in Asia.
Speaker 2: transcript
Speaker 2: In the first half of fiscal year 23, Antivio continued its growth trajectory, increasing market share globally.
In the first half of fiscal year 'twenty, three and keep your continued its growth trajectory increasing market share globally.
Speaker 2: transcript
Speaker 2: In the US, interview maintain the leaders number one in inflammatory bowel disease overall, as well as in IBD by UNAV New Staff.
In the U S and <unk> maintains a lead is number one in inflammatory bowel disease overall as well as in IBD bio naive new stocks.
Volume growth remained strong in the in the us and Europe at approximately 15%.
Speaker 2: transcript
Speaker 2: Volume growth remains strong in Europe at approximately 15%.
Speaker 2: transcript
It's performing as the overall IBD advanced therapy market despite pricing headwinds.
Speaker 2: transcript
Speaker 2: In the US, the IVD market is growing, but diagnosis and advanced therapeutic initiation remains suppressed, compared with the 2016-2019 period, so prep of it.
In the U S. The IBD market is growing but diagnosis and advanced therapy nutrition remains suppressed compared with the 2016 2019 periods or pre COVID-19.
Speaker 2: transcript
Speaker 2: Patient data suggests that new diagnoses still haven't recovered to pre-COVID level.
Patient that that suggests that new diagnosis she'd havent recovered to pre COVID-19 level.
Speaker 2: transcript
Nevertheless, the majority of moderate to severe patients remain untreated or on a conventional therapy. So we continue to see significant opportunities in our commercial organization is working very hard to expand our leadership in this area.
Speaker 2: transcript
Speaker 2: Moving to the right side of the slide, a near and long-term growth catalyst.
Moving to the right side of this slide and near and long term growth catalyst.
Speaker 2: transcript
Speaker 2: The US approval of the subcutaneous administration for maintenance therapy in the suractive collitis was a major milestone, making on TV the only FDA approved biologic in the suractive collitis that offer patients a choice of two types of administration.
The U S approval of the subcutaneous administration for maintenance for IP in interactive colitis was a major milestone in making <unk>. The only FDA approved biologic initiated could I teach that offer patients a choice of two type of administration.
Speaker 2: transcript
Speaker 2: Subcontinuous therapies are estimated to represent approximately 35 to 40% of the total US IBD market. So this is a very significant milestone that will allow us to access this new market sector.
So continuous therapy is estimated to represent approximately 35% to 40% of the total U S. IBD market. So this is a very significant milestone.
It allow us to access this new market segment.
We expect <unk> opinion to be available in the U S. By year end of October and we are fully committed to the success of its films.
Speaker 2: transcript
Speaker 2: We expect AntivioPen to be available in the U.S. by the end of October , and we are fully committed to the success of its...
<unk> is also evaluating our application for subcutaneous administration of anti beautiful corn disease.
Speaker 2: transcript
Speaker 2: The FDA is also evaluating our application for subcutaneous administration of on-TV for corn disease. A decision is expected later this fiscal year.
And as expected later this fiscal year.
Speaker 2: transcript
Speaker 2: We are pursuing new and ongoing life cycle management to enhance long-term growth and making significant investment in both ulcerative colitis and Crohn's disease studies to support targets of disease clearance and transmural healing. And we are initiating new studies to support the scientific community to investigate the potential role of combination therapies to break the efficacy ceiling with medulizumab as a backbone.
We are pushing new one ongoing lifecycle management to enhance long term growth and making significant investments in both the strategic criteria and quantities to these to support targets of disease clearance and transmitter on eating.
And we are initiating new studies to support the scientific community to investigate the potential role of combination therapies to breakthrough efficacy saving with <unk> as the backbone.
Speaker 2: transcript
Speaker 2: Healthcare professionals and patients are continuing to see the benefits and value that on-tv you offer in IBD and we remain confident with our peak revenue forecast at $7.5 to $9 billion with no change to biosimilar entry assumption timing, potentially as late as 2013.
Health care professionals and patients are continuing to see the benefit and value that on TV offering IBD and we remain confident with our peak revenue forecast at 752 9 billion U S. Dollar with no change to Biosimilar entry assumption timing potentially as late as 2000.
32.
Speaker 2: transcript
Speaker 2: On slide 8, QDNGAP continues to be recognized as an important development in the fight against the NGIFI.
On slide eight if you didn't get continues to be recognized as an important development in the fight against dengue fever.
Speaker 2: transcript
Speaker 2: We are seeing strong initial demand in private market in the mid countries, as well as strong long-sheet in travel markets led by the EU.
We are seeing strong initial demand in private market <unk> countries as well as strong loan she didn't travel market led by the U S.
Speaker 2: transcript
Speaker 2: This makers of chemistry, considering a public vaccination program, has not started.
You just make us optimistic considering that public vaccination program has not started yet.
Speaker 2: transcript
Speaker 2: CUNENGA has already launched in dengue endemic countries, Indonesia, Brazil and Thailand, and recently received approval in Colombia. We expect launch in Argentina in the third quarter of this fiscal year.
Can you guys have already launched in dengue endemic countries, Indonesia, Brazil, and Thailand, and recently received approval in Colombia.
We expect launch in Argentina in the third quarter of this fiscal year.
Speaker 2: This vaccine is sold in 16 European countries and is used to support travel and provide protection for travelers against dengue. We are implementing public-private partnerships for governments, ministries, NGOs, and manufacturers. Last month, the WHO's Expert Immunization Advisory Group recommended high usage for children aged 6 to 16 due to the dengue burden and vaccination coverage. The group suggested that this recommendation for this population would have the greatest impact on protection against dengue, leading to the expansion of protection over time. By expanding protection against dengue, we aim to ultimately guide countries worldwide to implement official dengue vaccination programs, laying the foundation for vaccine use globally, especially in developing countries. In countries where dengue is eventually ratified, international government recommendations will be considered, and decisions will be made regarding its domestic use. Now, we return to the high-level views of Nair, Medium, and Long-Term. Our strategy continues from the original situation, as it is linked to two aspects of fiscal year 23. We expect to return to Nair, Long-Term profit and margin growth. We also see great potential in our late-stage pipeline assets. This year, we aim to achieve significant data and regular milestones, predicting an increase in pipeline milestones in the second year. Continuing the overall competition of Vivant will impact this fiscal year's profit and margin growth, and similarly in 2024, it may be limited to the development of exclusivity until the launch of anti-biosimilar, which may be released by 2032. By combining the strength of our launch and growth with repeated R&D investments, we can achieve long-term profit and margin growth. We are contributing to profit and margin growth in the mid-30s. We support value creation using data and technology. We continuously evaluate financial business development opportunities, enhancing pipeline milestone increases and growth profiles. Finally, regarding our progressive financial policy, the increase and maintenance of financial assets continue the full-year margin guide. By increasing financial assets, we advance the pipeline to create long-term profits. We aim to achieve our goal of providing a better aspect to people for a brighter future worldwide, creating long-term financial profits.
Speaker 2: transcript
Speaker 2: The vaccine is available in 16 European countries and travel recommendations support its use to help protect travelers to dengue endemic areas.
The vaccine is available in 16 European countries on troubled recommendations to report, it's yours to help protect traveler with dengue endemic areas.
Speaker 2: transcript
Speaker 2: And we are pursuing private and public partnership with government, institutional businesses, NGOs, and manufacturers to expand.
And we are pushing private public partnership with government institutional businesses Ngos on manufacturers to expand access.
Speaker 2: transcript
Speaker 2: Last month, the WHO Strategic Advisory Group of Experts on Immunization, or SAGE, recommended its use in high dengue burden and transmission area for children age six to 16.
Last month the <unk>.
Will you choose strategic advisory group of expert on immunization or SGR rig come on it it's using nine dengue burden and transmission RF for children age six to 16.
Speaker 2: transcript
Speaker 2: SAGE assessed that the recommendation in this population would have the greatest public health impact as the vaccines could be administered to children prior to the time in which they are the greatest likelihood of possible dengue-related hospitalization.
Satish assess that a recommendation engine population will have the greatest public health impact as the vaccines could be administered to children. Prior to the time in which they are the greatest likelihood of placebo dengue related was Peter legislation.
Evaluation was based on data from pre then get clinical programs with more than 28000 participants.
Speaker 2: transcript
Speaker 2: The evaluation was based on data from pre-dengered clinical programs with more than 28,000 parts.
Speaker 2: transcript
Speaker 2: The recommendation is significant because it will ultimately provide overarching guidance to countries around the world on how and when to implement vaccines into their public vaccination programs and lay the foundation for access to vaccines worldwide, particularly in developing countries.
The recommendation is significant because it because they're typically provide overarching guidance two countries around the world on how on when to implement vaccines into the public vaccination programs and lay the foundation for access to vaccines worldwide, particularly in developing countries.
Speaker 2: transcript
Speaker 2: In countries where Qudenga is ultimately approved, it is now up to national authorities to consider the side recommendation and decide how Qudenga should be used local.
In countries, where do you think guys a committee approved.
Now up two national authorities to consider other sides recommendation and decide how do you think that should be used locally.
Okay.
Speaker 2: transcript
Speaker 2: Now I'd like to turn to our high level outlook for the near, medium, and long term.
Now I'd like to turn to our high level outlook for the near and midterm and long term.
Speaker 2: transcript
Speaker 2: Our strategy remains on track as we enter the second half of the fiscal year.
Our strategy remain on track as we enter the second half of the fiscal year.
Speaker 2: transcript
Speaker 2: Based on our current assumption for fiscal year 23, we expect to return to revenue profits on margin growth in the near term, driven largely by the continued expansion of our growth and launch product.
Based on our current assumption for fiscal year 'twenty three we expect to return to revenue profit and margin growth in the near term drill.
Driven largely by the continued expansion of our growth and launch products.
We're supposed to see significant potential in our late stage pipeline assets.
Speaker 2: transcript
Speaker 2: We are sourcing significant potential in our late stage Python.
Speaker 2: transcript
Speaker 2: We achieved significant data on regulatory milestone this year and anticipate the number of additional pipeline milestones in the second semesters.
We achieved significant that done regulatory milestone this year and anticipate a number of additional pipeline milestone in the second semester.
Following generic competition for violence.
Speaker 2: transcript
Speaker 2: which is impacting revenue on profit growth in this fiscal year and also in 2024. We have limited loss of exclusivity exposure until the launch of interview by your similar task which could occur as late as 2013.
Which is impacting revenue and profit growth in this fiscal year and also in 'twenty 'twenty four we have limited loss of exclusivity exposure on until the launch of <unk>, but you'll see me to ask which could occur as <unk>.
As 2032.
Speaker 2: transcript
Speaker 2: The momentum from our growth and launch product, combined with our continued investment in R&D, will drive progress in the medium and long term.
The momentum from our golf on launch product combined with our continued investment in R&D will drive progressing the medium and long term.
Speaker 2: transcript
Speaker 2: Looking ahead, we remain committed to returning to cooperating profit margins in the low to mid 30s, supported by value creation enabled by data and technology, including AI.
Looking ahead, we remain committed to returning to call putting profit margins in the low to mid thirties supported by value creation enabled by that technology, including AI.
Speaker 2: transcript
Speaker 2: We will also continue to evaluate asset-specific business development opportunities to further enhance our pipeline and reinforce our growth profile.
We will also continue to evaluate asset specific business development opportunities to further enhance our pipeline and reinforce our growth profile.
Speaker 2: transcript
Speaker 2: Finally, our progressive dividend policy of increasing or maintaining the dividend each year will allow us to continue to return value to shareholders.
Finally, our progressive dividend policy of increasing or maintaining the dividend each year would allow us to continue to return value to shareholders.
Speaker 2: transcript
Speaker 2: In closing, our strategy remains on track and we are maintaining our management guidance for the full year.
In closing our strategy remains on track and we are maintaining our management guidance for the full year.
Speaker 2: transcript
Speaker 2: We continue to progress our pipeline and manage our on-market portfolio to create long-term value for our stakeholders while we fulfill our purpose of bringing better health for people and a brighter future for the world. I will now pass it on to Andy to talk about.
We continue to progress our pipeline and manage our on market portfolio to create long term value for stakeholders why do we fulfill our purpose of bringing better health for people under a brighter future for their work.
Speaker 2: Next, I would like to hear from Endi about the progress of the pipeline. Thank you very much, Christoph. I would like to express my great gratitude to everyone at today's press conference. Please move on to the next slide. Christoph has announced that efforts have been made towards the progress of the pipeline this time. Based on such proposals, we would like to proceed with international measures to update the indicators for future vaccinations. Receiving the Eosinophilic Esophagitis (EoE) for the administration of Tac721 is an important step for this program and for patients. Details about the reception of this program will be explained in a later presentation. We have incorporated two new programs into this year's vaccination. Tac212 has been received from Acurastem. Tac212 is one of the five programs for the administration of antisense oligonucleotides for Amyotrophic Lateral Sclerosis. We expect to incorporate it into the Indy-Ready Program. The lines of the setup are the nine characteristics of the Indy-Ready Program. We will utilize the upcoming reception as collision testing. The upcoming Atchifure Fucked Iroscomikai and Indy-Ready Program are scheduled to conduct a lot of ion addition in the free medical field of the Taxuka Union in Japan. Furthermore, in order to allow for significant clearance of the target matter called Alserin tier and to support the taste of the Taxcomikai, we are conducting Phase 3 research that is being inherited in Japan and Europe. We continue to believe in the benefits shown by Arlofacel. We continue to believe in the positive pivotal studies in Japan, such as Admire 1, Admire 3, Admire 4, and other records like Inspire, as well as the real-world evidence of about 800 people in Europe.
I will now pass it onto and did you talk about a pipeline progress. Thank you.
Speaker 3: transcript
Speaker 3: Thank you very much, Christophe, and a big hello to everyone on today's call. If you can go to the next slide, please. We've made solid progress advancing. Our pipeline this quarter, is you just heard from Christophe. I'll take this opportunity to dive a bit deeper into several of the updates that Christophe just provided.
Thank you very much Christophe and Hello to everyone on today's call cause them to the next slide please we.
We've made solid progress advancing our pipeline this quarter as you just heard from Christophe I'll take this opportunity to dive a bit deeper into several of the updates that Christophe just provided.
Speaker 3: transcript
Speaker 3: Tax 279 read out positive ways to be data for the treatment of psoriatic arthritis.
279 read out positive phase <unk> data for the treatment of Psoriatic arthritis based on these positive data, we will advance catfish seven nine to a phase III development program for Psoriatic arthritis in fiscal year 2020 for the full results will be presented at the meeting of the American College of Rheumatology in November.
Speaker 3: transcript
Speaker 3: Based on these positive data, we will advance tattoo seven nine to a phase three development program for Suriada Carthritis in fiscal year 2024. The full results will be presented at the meeting of the American College of Rhumatology in November as a late breaker abstract.
As a late breaker abstract.
Speaker 3: transcript
Speaker 3: The Subcutaneous Administration of Antivio received a significant approval in the U.S. this quarter for maintenance therapy in adults with ulcerative colitis. This new route of administration provides an additional way for patients to benefit from antivio at home.
Cutaneous administration of Entyvio received a significant approval in the U S. This quarter for <unk> for maintenance therapy in adults with ulcerative colitis. This new route of administration provides an additional way for patients to benefit from Entyvio at home and <unk>.
Speaker 3: transcript
Speaker 3: Antivio subcutaneous administration has also been filed for the treatment of adults with Crohn's disease in the US and is currently under review by the FDA with potential approval in fiscal year 2024. In Japan, Antivio subcutaneous administration is now available for both UC and Crohn's disease following successful approvals in fiscal year 2023.
Video Subcutaneous administration has also been filed for the treatment of adults with Crohn's disease in the U S. And is currently under review by the FDA with the with potential approval in fiscal year 2024.
In Japan, Entyvio subcutaneous administration is now available for both UC and Crohn's disease following successful approvals in fiscal year 2023.
Speaker 3: As you just heard from Christoph, Gdania received a very important recommendation from the World Health Organization's advisory group, endorsing public vaccination programs in countries with high dengue burden in children ages 6 to 16 years.
As you just heard from Christophe Hidalgo received a very important recommendation from the World Health organization's Advisory group endorsing public vaccination programs in countries with high dengue burden in children ages six to 16 years, we expect the WHI updated its guidelines shortly based upon these recommendations.
Speaker 3: transcript
Speaker 3: We expect the WHO to update its guidelines shortly based upon these recommendations and look forward to continuing discussions with public health authorities and gang-e-indemic countries.
And look forward to continuing discussions with public health authorities in dengue endemic countries.
Speaker 3: transcript
Speaker 3: The resubmission of TAC721 for eosinophilic esophagitis, or EOE, to the FDA is an essential milestone for this program, as well as for patients. I will describe the process that led to this filing later in the presentation.
The Resubmission of <unk> 71 for eosinophilic esophagitis or E. L E to the FDA is an essential milestone milestone for this program as well as for patients I will describe the process that led to this filing later in the presentation.
Speaker 3: Momentum this quarter also came from two new additions to our pipeline. We licensed PAC-212 from Acura stem. PAC-212 is an interethical anti-sense oligonucleotide targeting PAC-5 for the treatment of amyrophobic lateral sclerosis or ALF.
Momentum. This quarter also came from two new additions to our pipeline. We licensed pack 212 from accurate Stan.
Do you want to use an interest equal anti sense oligonucleotide targeting pick five for the treatment of amyotrophic lateral sclerosis, or a L. S. We look forward to bringing this near <unk> ready program to the clinic in the very near future.
Speaker 3: transcript
Speaker 3: We look forward to bringing this near-IND-ready program to the clinic in the very near future.
Speaker 3: transcript
Speaker 3: We also licensed from a munerjan, Japan rights, to Miir v. Tuximab, a promising antibody drug conjugate targeting folate receptor alpha positive ovarian cancer.
We also licensed from Immunogen, Japan rights to mirror text them add a promising antibody drug conjugate targeting folate receptor alpha positive ovarian cancer.
Speaker 3: transcript
Speaker 3: In addition to these major updates, we also faced a couple of headwinds this past quarter. As Christophe just alluded to, we announced that a low-facil did not meet the primary endpoint in the Admire 2 study.
In addition to these major updates we also faced a couple of headwinds this past quarter.
It's Christophe just alluded to you we announced that our local sales did not meet the primary endpoint in the admire two study.
Speaker 3: transcript
Speaker 3: The results are disappointing, particularly given the robust benefits previously demonstrated in the Admire 1 Phase 3 study, which served as the basis for approval in Europe and Japan.
The results are disappointing, particularly given the robust benefits previously demonstrated in the admire one phase III study, which served as the basis for approval in Europe and Japan.
Speaker 3: transcript
Speaker 3: We continue to believe in the benefits demonstrated by a low-facel in admire one, as well as in other trials, such as the positive Japanese pivotal study and the inspire registry, an 800-patient European real world body of evidence.
We continue to believe in the benefits demonstrated by a law for sell in in Myer, one as well as in other trials such as the positive Japanese pivotal study and the inspire registry and 800 patient European real world body of evidence.
Speaker 3: We conducted an Exkivity test, which is a test for exon 20 non-small cell adenocarcinoma using EGF inoculant. We are starting the overall voluntary removal of Exkivity. Can we move to the next slide? What is shown here is a program with a delay period unlike before. The highest priority program for TAC279 was first published as part of a phase 3 protocol for tumor treatment on ClinicalTrials.gov. We are planning to start graduation soon. We believe that TAC279 has the potential to be the highest-grade oral therapy for tumor treatment. As I mentioned earlier, due to the phase 2B test for tumor treatment, TAC279 will transition to the second phase 3 development program held at the end of 2024. We are exploring clonal tumors, tumor diseases, systemic lupus erythematosus, and other possible indicators. Such possibilities are being developed simultaneously with tumor diseases and systemic lupus erythematosus. Now, TAC721 has been announced. This is announced in America for EOE. I will talk about it in the next slide. TAC721 is a defatted topical steroid designed for specific tumor therapy. Please see what is on the right side of the slide. In America, due to strong data and the remaining essential demand, it has helped with significant grassroots support for TAC721 in the GIA and EOE communities. We will further assist in collaboration with this community. We are resuming the NDA support package and focusing on critical data analysis over 12 weeks. We are responding to the filing of 721 for the treatment of EOE. Please see the next slide. Here, we show our mid-stage pipeline. In our Elexen franchise, we are active with the latest developments. We believe that the Elexen receptor 2 agonist provides functional treatment as the first agent to address the underlying cause of narcolepsy type 1. TAC861 is graduating early due to two phase 2B trials held in January 2023. Additionally, approximately 180 patients graduated from the phase 2B trials for narcolepsy type 1 and narcolepsy type 2. TAC861 reduces the effective effects more effectively than pre-measured brain Elexen agonists. Including renal toxicity. By brain Elexen agonists.
Speaker 3: transcript
Speaker 3: In addition, last quarter, we announced that the confirmatory trial for excivity in EGF receptor X-on-20 insertion positive, non-small cell lung cancer, hip futility.
In addition last quarter, we announced that the confirmatory trial. It breaks guilty in EGF receptor exon 20 insertion positive non small cell lung cancer kept utility we intend to initiate a global voluntary withdrawal of excuse me. They can go to the next slide. Please depicted here are exciting late stage program.
Speaker 3: transcript
Speaker 3: we intend to initiate a global voluntary withdrawal of Xkimity. If you can go to the next slide, please. Depicted here are exciting late-stage programs.
Speaker 3: transcript
Speaker 3: TAC 279, our highest priority program, has posted the first in a series of phase three protocols for psoriasis on clinical trials.gov, and is on track to begin enrollment very soon.
That 279, our highest priority program has posted the first in a series of phase III protocols for psoriasis on clinical trials Dot Gov and is on track to begin enrollment very soon.
Speaker 3: transcript
Speaker 3: We believe that TAC-279 is a potential best-in-class oral therapy for psoriasis.
We believe the path to seven nine as a potential best in class oral therapy for psoriasis.
Speaker 3: transcript
Speaker 3: As previously mentioned, based on the Phase IIB readout and psoriatic arthritis, we will move forward, TAC279, into a second pivotal Phase III development program early in fiscal year 2024.
As previously mentioned based on the phase <unk> readout in Psoriatic arthritis, we will move forward Tac 279 into our second pivotal phase III development program early in fiscal year 2024.
Speaker 3: transcript
Speaker 3: We're also accelerating development of Pact279 in Crohn's disease, ulcerative colitis, and systemic lupus arithematosis, as well as exploring a range of other potential indications. These expansion opportunities are being developed in parallel with psoriasis and psoriatic arthritis.
We're also accelerating development of tap 279 in Crohn's disease.
Sort of colitis, and systemic lupus erythematosus as well as exploring a range of other potential indications. These expansion opportunities are being developed in parallel with psoriasis and psoriatic arthritis.
Speaker 3: transcript
Speaker 3: A new addition to the late stage pipeline is now tacked to 721, which was filed in the US for EOE. And I'll talk about that on the next slide.
A new addition to the late stage pipeline is now tap to 71, which was filed in the U S for OA and I'll talk about that on the next slides.
Speaker 3: transcript
Speaker 3: Step 721 is a viscous topical steroids specifically designed to locally treat EOI.
That 721, as a viscous topical steroids, specifically designed to locally treat E O N E.
Speaker 3: transcript
Speaker 3: You can see on the right side of this slide, the significant responses at week 12 on both histology and symptoms, the co-primary endpoints of this pivotal trial. The clinical response in these patients started as early as week four. There's a high unmet medical need in the US for an oral treatment option that can act rapidly and locally in the esophagus. There's only one approved agent for EOE in the US, a systemic biologic that showed significant benefits at 24 weeks.
You can see on the right side of this slide the significant responses at week 12 on both histology and symptoms. The co primary endpoints of this pivotal trial. The clinical response in these patients started as early as week for.
There's a high unmet medical need in the U S for an oral treatment option. They can act rapidly and locally in the esophagus. There's only one approved agent for OE in the U S. A systemic biologic that showed significant benefits at 24 weeks the.
Speaker 3: transcript
Speaker 3: The strong data and remaining unmet need in the U.S. spurred significant grassroots support for TAC 721 from the GI and EOE community.
The strong data and remaining unmet need in the U S spurred significant grassroots support for tax 71 from the Gi and ear community.
Speaker 3: transcript
Speaker 3: We have been collaborating with these communities to uncover additional benefits.
We have been collaborating with these communities to uncover additional benefits we.
Speaker 3: transcript
Speaker 3: We have now revised our NDA submission package with additional data analysis focused at week 12 and are cautiously optimistic for our filing of seven to one for the treatment of the OE. Next slide, please.
We have now revised our NDA submission package with additional data analyses focused at week 12 and are cautiously optimistic for a filing of <unk> 71 for the treatment of the OE next slide please.
Speaker 3: transcript
Speaker 3: Here we show our promising mid-stage pipeline. We continue to be energized by recent developments in our Erexin franchise. We believe Erexin receptor 2 agonists have the potential to be the first agents to address the underlying cause of narcolepsy type 1, offering the potential for functional cures. TAC861 has completed enrollment well ahead of schedule in two Phase IIb trials that started in January of 2023.
Here, we show our promising mid stage pipeline, we continue to be energized by recent developments in our our Orexin franchise. We believe orexin receptor two agonists have the potential to be the first agents to address the underlying cause of narcolepsy type one offering the potential for functional cures.
<unk> has completed enrollment well ahead of schedule in two phase III trials that started in January of 2023 <unk>.
Speaker 3: transcript
Speaker 3: Combined, the narcolepsy type 1 and type 2 phase 2b trials have enrolled approximately 180 patients.
Combined the narcolepsy type one and type two phase III trials have enrolled approximately 180 patients.
Speaker 3: transcript
Speaker 3: That 861 is a more potent agent that may provide efficacy at a much lower dose than previously tested oral erection agon.
It takes one is a more potent agent then they provide efficacy at a much lower dose than previously tested oral orexin agonist.
Speaker 3: transcript
Speaker 3: significantly reduces the potential for adverse effects, including liver toxicity, which tends to be ghost-related.
Significantly reduces the potential for adverse effects, including liver toxicity, which tends to be dose related.
Speaker 3: An external investigation was conducted, confirmed by the Drug Monitoring Committee, and it was confirmed that there was no diagnosis of kidney odor. It has been confirmed that all patients participating in the long-term extension study will be extended for more than 102 weeks. The final event decision will proceed to receive the next-generation adenocarcinoma vaccination tumor, and it will continue for one and a half years in 2024 regarding the development of type 1 and type 2 kidney disease with TAK861. The final event decision will proceed to receive the next-generation adenocarcinoma vaccination tumor, and it will continue for one and a half years in 2024 regarding the development of type 1 and type 2 tumors. The final event decision will proceed to receive the next-generation tumor, and it will continue for one and a half years in 2024 regarding the development of type 1 and type 2 tumors. The final event decision will proceed to receive the next-generation tumor, and it will continue for one and a half years in 2024 regarding the development of type 1 and type 2 tumors. The final event decision will proceed to receive the next-generation tumor, and it will continue for one and a half years in 2024 regarding the development of type 1 and type 2 tumors. The final event decision will proceed to receive the next-generation tumor, and it will continue for one and a half years in 2024 regarding the development of type 1 and type 2 tumors. The final event decision will proceed to receive the next-generation tumor, and it will continue for one and a half years in 2024 regarding the development of type 1 and type 2 tumors. Hello everyone, this is Koster Sarkos. Today, I will explain the financial topics regarding the results of the first half of 2023. Let's start with the highest value. With a price of 2.1 trillion yen, or 14.1 billion dollars, an increase of 1.4%, let's start with the highest value.
Speaker 3: transcript
Speaker 3: The external reviews conducted by the Drug Monitoring Committee confirmed that no liver toxicity signals have been observed.
The external reviews conducted by the drug monitoring committee confirm that no liver toxicity signals have been observed.
Speaker 3: transcript
Speaker 3: We continue to see nearly all patients have complete the trials enrolling in the long-term extension study, which can extend up to 102 weeks.
We continue to see nearly all patients who complete the trials enrolling in the long term extension study, which can extend up to 102 weeks we.
Speaker 3: transcript
Speaker 3: We remain on track to make a final go-no go decision to advance Pack 861 to Phase 3 in Type 1 narcolepsy and Type 2 narcolepsy in the first half of calendar year 2024.
We remain on track to make a final <unk> decision to advanced package six one to phase III in type one narcolepsy and type two narcolepsy in the first half of calendar year 2024.
Speaker 3: transcript
Speaker 3: We are also on track to file an IND for our next generation oral receptor 2 agonist, oral, oral, oral, oral, orxin receptor 2 agonist later this fiscal year. Additional oral, orxin receptor 2 agonists will allow us to expand into a range of more prevalent disorders with sleep, wake, cycle, disruptions to fully explore the potential of these agents.
We're also on track to file an IND for our next generation oral receptor two agonists.
Oral ericsson or oral Orexin receptor two agonists later this fiscal year additional or additional oral orexin receptor two agonists will allow us to expand into a range of more prevalent disorders with sleep wake cycle disruptions to fully explore the potential of these agents.
Speaker 3: transcript
Speaker 3: Mesogitamab is our fully humanized anti-CD38 monoclotal antibody that has been studied across several rare autoimmune and inflammatory diseases. Mesogitamab depletes plasma cells, resulting in substantial and durable reduction of pathogenic immunoglobulins, leading to potentially meaningful improvements in IgG and IgA mediated autoimmune diseases.
Mirza get a mab as our fully humanized anti CD 38, monoclonal antibody that has been studied across several rare autoimmune and inflammatory diseases.
<unk> depletes plasma cells, resulting in substantial and durable reduction of pathogenic immunoglobulins, leading to potentially meaningful improvements in <unk> and Iga mediated autoimmune diseases.
Speaker 3: transcript
Speaker 3: In addition, there is a suggestion that mesogitimab improves the rapidity of the clinical response in immune thrombocytopenic purpura, or ITP, by eliminating CD38-positive immune effector cells, which are directly responsible for platelet destruction. Later this fiscal year, we are looking forward to emerging data in IgA nephropathy and ITP. Could you go to the next slide, please?
In addition, there is a suggestion that navigate a mab improves the rapidity of the clinical response and immune thrombocytopenic purpura or pay by eliminating CD 38 positive immune effector cells, which are directly responsible for platelet destruction.
Later this fiscal year, we are looking forward to emerging data in Iga nephropathy, and ITK, but go to the next slide please.
Speaker 3: transcript
Speaker 3: Here are select regulatory approvals and phase three readouts for fiscal year 2023. In addition to states described previously for subcutaneous and Tibio and a lofisio, Kedanga received approval in Columbia this quarter. This is the fifth endemic country that has approved Kedanga.
There are select regulatory approvals and phase III Readouts for fiscal year 2023. In addition to dates described previously for subcutaneous <unk>.
Oh, and a low physio dang.
To dangle received approval in Colombia. This quarter. This is the fifth endemic country that is approved Katanga with.
Speaker 3: transcript
Speaker 3: With the potential approval of PAC 721 later this fiscal year, we now have an opportunity to receive three new new molecular entity approvals in the US in fiscal year 2023.
With the potential approval of <unk> seven to one later this fiscal year, we now have an opportunity to receive three new new molecular entity approvals in the U S in fiscal year 2023.
Speaker 3: transcript
Speaker 3: This next quarter, we expect to hear a decision in the US about Fukintinim, our selective oral vegeph inhibitor for metastatic colorectal cancer. And we also expect to hear the FDA's response to our submission of PAC-755, an atom PS-13 enzyme replacement therapy for the treatment of congenital thrombotic thrombocytopetic perfora or C-TTP.
This next quarter, we expect to hear a decision in the U S about for Quintanilla, our selective oral digest inhibitor for metastatic colorectal cancer and we also expect to hear the Fda's response to our submission of pack 755, and add MTS 13 enzyme replacement therapy for the treatment of congenital thrombotic thrombocytopenic.
Purpura or see TTP.
Speaker 3: transcript
Speaker 3: Approval for this rare pediatric disease would fulfill a major unmet medical need. Thank you very much and I will now turn it over to Kastas.
Approval for this rare pediatric disease would fulfill a major unmet medical need.
Thank you very much and I will now turn it over to cost us.
Thank you Andy and Hello, everyone. This is costa Serco speaking today I will walk you through the financial highlights of our fiscal 2023 first half results starting.
Speaker 4: transcript
Speaker 4: Thank you Andy and hello everyone, this is Cosper Serucos speaking. Today I'll walk you through the financial highlights of our fiscal 2023 first half result.
Speaker 4: transcript
Speaker 4: Starting with a top line, revenue was 2.1 trillion yen or $14.1 billion US dollars, delivering growth of 1.4% versus prior year at constant exchange rate or 6.4% on an actual basis, including FX upside from the depreciation of the year.
Starting with the topline.
Revenue was $2, one trillion yen or $14 1 billion U S dollars delivering growth of one 4% versus prior year at constant exchange rate or six 4% on an actual basis, including ethics upsides from the depreciation of the yen.
Speaker 4: Our top-line performance, driven by our growth and launched products, represents approximately 42% of total revenue and increased the constant exchange rate by 13%. Core operating profit was 58.88 billion yen or 390 million dollars, with a core operating profit margin of 28%. Reported operating profit was 11.92 billion yen, and the impact of essential load burdens and other core operator load burdens will be explained in the next slide. Core operating profit was 26.1 billion yen, and reported profit was 2.7 billion yen. The impact of essential load burdens and other core operator load burdens, many core operator profits received a positive tax score in H1 due to tax measures from the tax recovery cost obtained by Shire in 2014, and the tax recovery cost for UK taxes, at the half-year point, the tax utilization rate was 29.13 billion yen, or 190 million dollars. The tax utilization rate decreased to 7.11 billion yen, and due to this year's tax recovery cost, the tax utilization rate exceeded 25 billion yen, and the tax utilization rate was 27.9 billion yen, and the tax utilization rate exceeded 4 billion yen. In Q2, progress is being made due to financial reductions. A $100 million bond that grew last September was paid, and the financial base maintains a stable financial base. The financial base maintains a stable financial base. The financial base maintains a stable financial base. Regarding the outlook for the full-year tax recovery cost, we will update our foreign trade level forecast, and our report forecast shows the impact of non-core items in the first half. Importantly, we are keeping up with the world in performance at essential exchange values under our management guidance. We also forecast the full-year tax recovery cost to be between 40 billion yen and 50 billion yen. Slide 18 explains the details of our first half financial performance. Let's start with the core results on the right side of the slide. At 2.1 trillion yen, an increase of 6.4% or 1.4% at constant exchange rates, driven by our growth and launched products, core profit was 58.88 trillion yen, an increase of 5.8% on an actual Fx basis or 9.5% at constant exchange rates. These reflect the impact of preferential competition for high-margin products.
Speaker 4: transcript
Speaker 4: Our top line performance was driven by our growth and launch products, which represents approximately 42% of total revenue and grew 13% at constant exchange rates.
Our topline performance was driven by our growth and launch products, which represents approximately 42% of total revenue and grew 13% at constant exchange rate.
Speaker 4: transcript
Speaker 4: Core operating profit was $588.8 billion or $3.9 billion US dollars with a core operating profit margin of 28%.
Core operating profit was $588 8 billion yen or 3.9 billion U S dollars with core operating profit margin of 28%.
Speaker 4: transcript
Speaker 4: reported operating profit was $119.2 billion yen, reflecting the significant impact of non-cash impairment losses and other non-core items that I will explain in the coming slide.
Reported operating profit was $119 2 billion yen, reflecting the significant impact of noncash impairment losses, and other noncore items that I will explain in the coming slides.
Speaker 4: transcript
Speaker 4: Core EPS was 261 yen and reported EPS was 27 yen, also impacted by several non-core items.
Core EPS was 261 yen and reported EPS was <unk> 27 yen also impacted by several non core items.
Speaker 4: transcript
Speaker 4: While many of these were headwinds to profit, we did book a positive tax gain in H1 as a result of our settlement with Irish Revenue over the tax treatment of an acquisition break fee received by Shire in 2014.
While many of these were headwinds to profit we did book a positive tax gain in H, one as a result of our settlement with Irish revenue either the tax treatment of an acquisition break fee received by Shire in 2014.
Speaker 4: transcript
Speaker 4: Moving to cash flow, we continue to see strong cash generation from the business, with operating cash flow of $291.3 billion or $1.9 billion for the first half of the year.
Moving to cash flow, we continued to see strong cash generation from the business with operating cash flow of $291 3 billion yen or $1.9 billion for the first half of the year.
Speaker 4: transcript
Speaker 4: Free cash flow was minus 71.1 billion yen, reflecting over 250 billion yen of cash out for acquisitions and in licensing so far this fiscal year, including the bills for PAC 279 and for quickening.
Free cash flow was minus $71 1 billion yen, reflecting the 250 billion yen of cash out for acquisitions and in licensing so far this fiscal year, including the deals for 279 and frequently.
Speaker 4: transcript
Speaker 4: In Q2, we continue to make progress with debt reduction, paying down a billion US dollars bond that matured in September .
In Q2, we continued to make progress with debt reduction paying down a billion U S dollars bond that matured in September.
Speaker 4: transcript
Speaker 4: and we maintain a resilient financial base with 100% of outstanding debt at fixed interest rates with a weighted average rate of approximately 2%.
And we maintain a resilient financial base with 100% of outstanding debt at fixed interest rates with a weighted average rate of approximately 2%.
Speaker 4: transcript
Speaker 4: With regards to the outlook for full year fiscal 2023, we have made updates to our foreign exchange rate assumptions. And our reported forecast also reflects the impact of the large non-core items we booked in the first half that were not part of the original forecast.
With regards to the outlook for full year fiscal 2023, we have made updates to our foreign exchange rate assumptions and our reported forecast also reflects the impact of the large noncore items, we booked in the first half that were not part of the original forecast.
Speaker 4: transcript
Speaker 4: Importantly, we continue to track world towards our management guidance for performance at a constant exchange rate.
Importantly, we continue to track well towards our management guidance for performance at a constant exchange rate.
Speaker 4: transcript
Speaker 4: Also, I want to emphasize that we are on track to delivering our four year free cash both forecasts of 400 to 500 billion yen.
Also I want to emphasize that we are on track to delivering our full year free cash flow forecast of 400 to 500 billion yen.
Speaker 4: transcript
Speaker 4: On slide 18, let me run through the details of our first half on Azure Performance.
On Slide 18, let me run through the details of our first half financial performance.
Speaker 4: transcript
Speaker 4: Starting with our core results on the right of the slide. You can see that revenue was 2.1 trillion yen with growth of 6.4%, or 1.4% at a constant exchange rate driven by our growth and launch product.
Starting with our core results on the right of the slide you can see that revenue was $2 one trillion yen with growth of six 4% or one 4% at constant exchange rates driven by our growth and launch products.
Speaker 4: transcript
Speaker 4: Core operating profit was 588.8 billion yen, a decline of 5.8% on an actual FX basis, or 9.5% at constant exchange rate. This reflects the impact of generic competition for high margin products, such as Velcade.
Core operating profit was $588 8 billion a decline of five 8% on an actual ethics basis or nine 5% at constant exchange rate. This reflects the impact of generic competition for high margin products, such as Velcade Dex.
Speaker 4: Dexcellent, Anazulva, and the coronavirus infection vaccine have reduced operating amounts, and were significantly impacted by the setbacks from Eskiviti and Alphysl, as well as the inventory write-off and collapse of the manufacturing plant. At the same time, we have made necessary investments in R&D, data, and technology to ensure the long-term success of the business. Core net profit and core EPS were affected by a slightly higher core tax rate than last year, with core EPS dropping to 261 yen in the first half, a 14.4% decrease compared to the previous year at constant exchange rates. The reported results are shown on the left side. The reported amounts are the same as the core amounts. The reported amounts were significantly impacted by large non-core items provided in Q2. These include the impact of the inventory write-off of 11.58 billion yen, mainly related to the readout of the phase 3 study of Alphysl and the voluntary global reduction of Eskiviti. We provided restructuring costs higher than the previous year and other operating expenses of 11.02 billion yen. These resulted in our reported amount being 11.92 billion yen, a 53% decrease year-on-year. Reported amounts and reported EPS decreased by about 75%. We recognized a tax benefit of 6.35 billion yen due to a tax dispute in the UK, but the higher impact of the inventory write-off compared to last year had a significant impact on the tax benefit in the first half. As shown in the previous slide, our tax benefit does not include the impact of the inventory write-off for TAC279 and Kryptonib, but our full-year reported amount remains unchanged at 40 billion to 50 billion yen. On slide 19, we would like to show the performance of our growth and launch products. These are key drivers of top-line growth. These products show the performance of the overall inventory write-off in the first half. Among our five business areas, G.I. showed a 3% increase in inventory write-off performance, and Dexellent's overall inventory write-off performance increased by 3%. Tibio's largest product increased by 6%, and performance continues to be good, but our expectations have slightly decreased. As Christoph explained, at the time, the inventory write-off sales plan was bad, and the inventory write-off commander was against the inventory write-off expansion volume, with backshaker, linearist, and other dilution, and the continued growth outlook of the authority client advisories product.
Speaker 4: transcript
Speaker 4: Dexcellent and a silver as well as lower COVID-19 vaccine revisions.
And as silver as well as lower COVID-19 vaccine revenue.
Speaker 4: transcript
Speaker 4: There was also a core growth margin impact from the setbacks to Exhibit and the aloe fissile due to inventory right off and impairment of manufacturing.
There was also a core gross margin impact from the setbacks to excuse me in the L official due to inventory write offs and impairment of manufacturing facilities.
Speaker 4: transcript
Speaker 4: Meanwhile, we have continued to make the necessary investment in R&D and data and technology to secure the long-term success of the business.
Meanwhile, we have continued to make the necessary investment in R&D and data and technology to secure the long term success of the business.
Speaker 4: transcript
Core net profit and core EPS is impacted by slight.
The higher core tax rate compared to last year with core EPS for the first half of 261 yen down 14, 4% versus prior year at constant exchange rate.
Speaker 4: transcript
Speaker 4: On the left hand side, you can see our reported results. Reported revenue is the same as core revenue. Reported operating profit was significantly impacted by some large non-core items that we booked in Q2. This included 115.8 billion yen of impairment of intangible assets, mainly related to the phase three study readout of aliphysal and our voluntary global withdrawal ,
On the left hand side, you can see our reported results reported revenue is the same as core revenue reported operating profit was significantly impacted by some large non core items that we booked in Q2.
This included $115 8 billion yen of impairment of intangible assets, mainly related to the phase III study readout of alethia, So and our voluntary global withdrawal of excuse me.
Speaker 4: transcript
Speaker 4: We also booked higher restructuring expenses than the prior year. And an additional legal provision, resulting in total other operating expenses of 110.2 billion yen.
We also booked higher restructuring expenses in the prior year and an additional legal provision, resulting in total other operating expenses of 110.2 billion yen.
Speaker 4: transcript
Speaker 4: These are reflected in our report operating profit result of a 119.2 billion yen, a year on year decline of 53.
These are reflected in our reported operating profit result of $119 2 billion a year on year decline of 53%.
Speaker 4: transcript
Speaker 4: reported net profit and reported EPS declined approximately 75%
Reported net profit and reported EPS declined approximately 75%.
Speaker 4: transcript
Speaker 4: Although we did book a 63.5 billion yen tax benefit due to the settlement of a tax dispute with Irish Revenue, our year-on-year net profit comparison was substantially impacted by one-time financial income booked in the first half of last year.
Although we did book a $63 5 billion yen tax benefit due to the settlement of a tax dispute with Irish revenue how are you.
Year on year net profit comparison was substantially substantially impacted by one time financial income booked in the first half of last year.
Speaker 4: transcript
Speaker 4: As highlighted on the previous slide, free cash flow reflected our cash payments for TAC279 and for Krittenib, but there is no change to our full-year forecast of 400 to 500 billion years.
As highlighted on the previous slide free cash flow reflected our cash payments for taxes, seven nine and for Cryptonym, but there is no change to our full year forecast of 400 to 500 billion yen.
On slide 19, I would like to highlight the performance of our growth and launch products, which are the key drivers of top line growth.
Speaker 4: transcript
Speaker 4: On slide 19, I would like to highlight the performance of our growth and large product, which are the key drivers of top-lying growth.
Speaker 4: transcript
Speaker 4: These products generated 42% of total revenue in the first half with 13% growth at constant exchange rate.
These products generated 42% of total revenue in the first half with 13% growth at constant exchange rate.
Speaker 4: transcript
Speaker 4: Within our five key business areas, GI grew plus 3% at constant exchange rate, a slow down versus last year impacted by generic entry of Dexalent in the US in January this year.
Within our five key business areas G. I grew plus 3% at constant exchange rate a slowdown versus last year impacted by generic entry of excellent in the U S. In January this year.
Speaker 4: transcript
Speaker 4: Our largest product, Intivio, continues to perform well with growth of 6%, but remains a little behind where our expectations had been. As Christoph explained, there continues to be softness in the US IBD market, and we are also being impacted by pricing headwinds in Europe .
Our largest product entyvio continues to perform well with growth of 6%, but remains a little behind where our expectations a bit.
As Christophe explain there continues to be softness in the U S. IBD market and we are also being impacted by pricing headwinds in Europe.
Speaker 4: transcript
Speaker 4: That said, we maintain the leading market share in the US, both in overall IBD prescriptions and in IBD-bi-naive new patient starts. And with approval last month of the subcutaneous device and ongoing investment in both marketing and lifecycle management, we remain fully confident in the continued growth outlook for the product.
That said, we maintained the leading market share in the U S. Both in overall IBD prescriptions and in IBD by naive new patient starts and with approval last month of the subcutaneous device and ongoing investment in both marketing and lifecycle management, we remain fully confident in the continue.
The growth outlook for the product.
Speaker 4: During the COVID-19 pandemic, Takzairo continued to amplify by 13%, was launched in over 50 countries, and has sustained demand in the United States. This has raised the full-year forecast for Takzairo, with a sustained success rate rising to 83% due to fierce resistance in the U.S. market and expansion in the European region. The immune technology of PDT has sustained an amplification of 17%, with immunoglobulin amplification at 19% and albumin amplification at 11%. The products of immunoglobulin and albumin continue to see sustained demand. Our plasma donation center network has added more than 10 centers in a year and a half, with the intention to increase by more than 20 centers by the end of the year. Due to the significant increase in annual amplification this year, we can advance the completion of the plasma donation center network to exceed the value chain of PDT, promoting contributions to patients. Next is oncology. Oncology is decreasing due to the generic of VELCADE. However, the timing of the oncology reduction in May 2022 needs to decrease in the first half of next year. By reducing VELCADE, the remaining portfolio will increase by 6%, driven by products like Lumbriq, Esetris, and Eclusig. Exkivity is currently at 350 million yen, approximately 2.5 billion dollars. The annual amplification and release categorism this year consider the reduction of Exkivity and the launch of new products over the next two and a half years. Neuroscience increased by 3% over a year and a half. In the case of a year and a half, Vyvanse showed strong performance, but as expected, the patent was delayed and released several times. At present, it matches the initial forecast. We are monitoring the erosion trend and are informed that changes may occur next April. Finally, other segments increased due to H1, as the burden of the coronavirus decreased in Japan. However, in this other segment, there is an urgent demand seen with the dengue vaccine, new product launches, and the travel market. The next three slides will allow comparison of the initial performance through the water force with the previous year.
In rare diseases <unk> Zara continues its strong momentum with growth of 13%, having successfully launched in over 50 countries and.
Speaker 4: transcript
Speaker 4: In rare diseases, Tax-Zyro continues its strong momentum with growth of 13%, having successfully launched in over 50 countries and with sustained demand in the US.
And with sustained demand in the U S.
Speaker 4: transcript
Speaker 4: This has actually led us to raising our full-year forecast for tax irons.
This is actually the led us to raising our full year forecast for Tech Zara.
Speaker 4: transcript
Speaker 4: We also see continued launch successful with density up to 83%. We're strong market penetration in the US and rapid geographical expansion within Europe .
We also see continued launch successful intensity up to 83% with strong market penetration in the U S and rapid geographic expansion within Europe.
Speaker 4: transcript
Speaker 4: PDT immunology continues to deliver outstanding growth of 17% including 19% growth of immunoglobulin and 11% growth of albamyl.
PDT immunology continues to deliver outstanding growth of 17%, including 19% growth immunoglobulin and 11% growth of albumin.
Speaker 4: transcript
Speaker 4: Both our IG and album and products continue to see strong demand. We have continued to expand our plasma donation center network, adding 10 more centers in the first half of the year, with the intent to increase by more than 20 new centers by the end of the fiscal year. And we have seen donor compensation on a downward trend since fiscal year 2022, after significant increases during the pandemic.
Both our <unk> and albumin products continue to see strong demand. We have continued to expand our plasma donation center network, adding 10 more centers in the first half of the year with the intent to increase by more than 20, new centers by the end of the fiscal year and we have.
Donor compensation on a downward trend since fiscal year 2022 after significant increases during the pandemic.
Speaker 4: transcript
Speaker 4: We now modulate compensation in a highly segmented way while achieving the volumes to deliver on our commitments to our patients.
We know modulate compensation in a highly segmented way, while achieving the volumes to deliver on our commitments to our patients.
Speaker 4: transcript
Speaker 4: Together with initiatives to improve efficiency across the PDT value chain, this has enabled us to improve PDT margins year on year for the first time since the pandemic.
Together with initiatives to improve efficiency across the PDT value chain. This has enabled us to improve PTT margins year on year for the first time since the pandemic.
Speaker 4: transcript
Speaker 4: Next is oncology, which continues to decline as a result of Velcade generics. However, the timing of loss of exclusivity in May 2022 means that the impact should wash out in the coming quarter.
Next is oncology, which continues to decline as a result of Velcade generics. However.
However, the timing of loss of exclusivity in May 2022 means that the impact should wash out in the coming quarters.
Speaker 4: transcript
Speaker 4: excluding Velcade, the rest of the portfolio grew 6% driven by products such as Alunbreg, Assetras and Ecluse.
Excluding velcade the rest of the portfolio grew 6% driven by products, such as our new brake et cetera and inclusive.
Speaker 4: transcript
Speaker 4: Excavity remains on this page for now with H1 revenues of 3.5 billion yen or approximately 25 million US dollars.
Excuse me remains on this page for now with H, one revenues of $3 5 billion yen or approximately 25 million U S dollars.
Speaker 4: transcript
Speaker 4: We'll revisit our growth and launch categorisation at the end of the fiscal year, taking into consideration the withdrawal of the X-Gibberish as well as potential new product launches we expect in the second half of the fiscal year.
We'll revisit outgrowth and launch categorization at the end of the fiscal year, taking into consideration the withdraw of excuse me as well as potential new product launches, we expect in the second half of the fiscal year.
Neuroscience grew at 3% in the first half of the year.
Speaker 4: transcript
Speaker 4: Neuroscience grew at 3% in the first half of the year.
Speaker 4: transcript
Speaker 4: We saw strong performance for Vibans in the first quarter, but as expected, we have seen several generic launches since the patent expired in August .
We saw strong performance for buybacks in the first quarter, but as expected we have seen several generic launch since the patent expired in August.
Speaker 4: transcript
Speaker 4: To date, the generic erosion curve has been generally aligned with our initial estimate.
To date, the generic erosion curve has been generally in line with our initial estimates.
Speaker 4: transcript
Speaker 4: We'll continue to monitor the erosion trend and we'll communicate in future quarters if anything changes our outlook.
We will continue to monitor the erosion trained and working communicating.
Communicating future quarters, if anything changes our outlook.
Finally, the other segment is declining in H, one mainly due to lower revenue from COVID-19 vaccines in Japan.
Speaker 4: transcript
Speaker 4: Finally, the other segment is declining in H1, managed due to lower revenue from COVID-19 vaccines in Japan.
Speaker 4: transcript
Speaker 4: However, this other segment now includes our Dengue vaccine, Qdenga, our newest growth and launch product, which is seeing strong initial demand in both endemic and travel sense.
However, this other segment now includes our dengue vaccine <unk>.
Our newest growth and launch product, which has seen strong initial demand in both endemic and travel markets.
Speaker 4: transcript
Speaker 4: Over the next three slides, I'll walk you through some waterfalls to better explain the moving pieces in our first half performance versus prior year. Starting with.
Over the next three slides I'll walk you through some waterfalls to better explain the moving pieces in our first half performance versus prior year.
Speaker 4: Let's start with the profit on slide 20. Compared to the previous year, the amplification of our development products was the main driver of a 1.4% increase in constant exchange rates, and it was more than enough to amplify the headwinds caused by the reduction in specific profits and coronavirus profits. On top of that, we were able to amplify our top-line growth to a practical profit of 6.4%. Next, I will explain the annual profit amplification on the profit bridge on slide 21. Here, the amplification of profits is greater than the profits due to the reduction in specific profits and coronavirus profits, affecting our product mix. This mix impacts the cost burden held in H1, with lending burdens and product lending burdens set as major costs in H1. In terms of investment, we are funding R&D to strengthen programs such as Tag 279 and EREXEN. R&D expenses increased by 10% due to constant exchange rates in the first half of the year, and we expect them to continue to increase. We also predict a slight increase for the entire year compared to the previous year. Additionally, we are making significant investments in data and technology, including AI, to expand the value chain. We believe this investment will have a transformational impact on long-term competitiveness, and we aim to continue investing in this area. At the same time, we are dealing with strict values to reduce more OPEX than the previous year. We also want to focus on FX. Due to FX values, the USD value is declining, and this value affects other investments such as R&D. The half-year transformational value decline is 9.5%, with a step-by-step exchange rate base of 5.8%. Due to FX values, the overall value is 5.8%. Next, I will explain the value decline on the second slide. The half-year transformational value decline is 9.5%, with a step-by-step exchange rate base of 5.8%. Due to FX values, the overall transformational value decline is 5.8%. Next, regarding the high and low values of AAV treatment, by fixing the cross-linearity of the office, this year's legal assistance book has been submitted, and all assistance books have been completed.
Starting with revenue on slide 20.
Speaker 4: transcript
Speaker 4: you can see that versus prior year, our growth and launch products were the main driver of our 1.4% growth at constant exchange rate, more than offsetting the headwinds from loss of exclusivity and lower coronavirus vaccine.
You can see that versus prior <unk> outgrowth and launch products were the main driver of a one 4% growth at constant exchange rates more than offsetting the headwind from loss of exclusivity and lower Corona virus vaccine revenue.
Speaker 4: transcript
Speaker 4: On top of this, we had an FX tailwind due to the depreciation of the yen, taking our top line growth on an actual FX basis to 6.4%.
On top of this we had an FX tailwind due to the depreciation of the yen, taking our top line growth on an actual FX basis to six 4%.
Speaker 4: transcript
Speaker 4: Moving to the year-on-year core operating profit bridge on slide 21.
Moving to the year on year core operating profit bridge on slide 21.
Speaker 4: transcript
Here, you can see how loss of exclusivity and Corona virus vaccines are having a larger impact on profit compared to revenue due to the higher margins impacting our product mix.
Speaker 4: transcript
Speaker 4: This mix was also impacted by some cost of goods expenses booked in H1 related to excivity inventory write offs and manufacturing write offs for aliphysel, both of which are treated as core expense.
This mix was also impacted by some cost of goods expenses booked in H, one related to excuse me the inventory write offs and manufacturing write offs for all official both of which are treated as core expenses.
Speaker 4: transcript
Speaker 4: On the investment side, we continue to allocate resources to R&D to support high potential programs such as CAC279 and our O'Rexan franchise.
On the investment side, we continue to allocate resources to R&D to support high potential programs, such as tap 279, and our Orexin franchise.
Speaker 4: transcript
Speaker 4: R&D spend in the first half increased almost 10% on a constant exchange rate basis, but this reflects phasing as expected. And for the full year, we anticipate a mid single digit increase versus prior year.
R&D spend in the first half increased almost 10% on a constant exchange rate basis, but this reflects phasing as expected and for the full year, we anticipate a mid single digit increase versus prior year.
Speaker 4: transcript
Speaker 4: We also continue to make substantial investment in data and technology, including AI across the value chain. We believe these investments will have a transformational impact on together as long-term competitiveness, and therefore we continue to allocate capital in these areas as they will play a major role in our return to growth in the near and long term.
We also continued to make substantial investment in data and technology, including AI across the value chain. We believe these investments will have a transformational impact on ticket as long term competitiveness and therefore, we continue to allocate capital in these areas as they will play a major role in our return to growth in the near and long term.
Speaker 4: transcript
Speaker 4: At the same time, we are applying street cost discipline to reduce other off-ex versus prior year.
At the same time, we are applying strict cost discipline to reduce other opex versus prior year.
Speaker 4: transcript
Speaker 4: I also want to draw your attention to FX, which is less favorable than the FX to revenue. And this is due to much of our expenses being in euros for cost of goods and in US dollars for R&D and other investments.
I also want to draw your attention to ethics, which is less favorable than the FX to revenue and this is due to much of our expenses being in euros for cost of goods and in U S dollars for R&D and other investments.
Speaker 4: transcript
Speaker 4: All these factors combined resulted in a first half co-operating profit decline of 9.5% on a constant exchange rate basis or 5.8% decline when factoring the FX.
All these factors combined resulted in a first half cooperating profit decline of nine 5% on a constant exchange rate basis, or five 8% decline when factoring.
The FX.
Speaker 4: transcript
Speaker 4: Next is slide 22, which explains the major items impacting our reported operating profit versus previous year.
Next is slide 22, which explains the major items impacting our reported operating profit versus previous year.
Speaker 4: transcript
Speaker 4: Here you can see the sizeable increase in impairment of intangible acids, which totaled 115.8 billion yen in the first half, mainly due to the negative phase 3 study readout of our official and the voluntary global withdrawal of exclusivity.
He you can see the sizable increase in impairment of intangible assets, which totaled $115 8 billion yen in the first half mainly due to the negative phase III study readout of <unk> and the volatile voluntary global withdrawal of excuse me.
Speaker 4: transcript
Speaker 4: In addition to that, we had an increase in other operating expense.
In addition to that we had an increase in other operating expenses.
Speaker 4: transcript
Speaker 4: This included higher restructuring cost related to exiting AAV gene therapy and consolidating our office footprint. It also includes an additional legal
This included higher restructuring cost related to exiting AAV gene therapy, and consolidating our office footprint.
It also includes an additional legal provision book this year.
Speaker 4: transcript
Speaker 4: All these items combined led to the reported operating profit decline of 53.2%.
All these items combined led to the reported operating profit decline of 53, 2%.
Speaker 4: Next, let's move to slide 23 and discuss the financial outlook for the entire fiscal year. Based on the results from the first half, there is no need to improve management guidance at this stage. Currently, the prioritized reductions in Vyvanse and Azilva align with our initial expectations, so we continue to adjust our management guidance. We are implementing a low single-digit reduction, a 10% reduction in core open profit, and a 20% reduction in core EPS, or setting it based on the exchange rate. We have updated our FX forecast, and with an increase of 14 billion yen in our revenue forecast, it has reached 398 billion yen. The reported open profit and EPS were impacted by large non-core items set in the first half core. Our core open profit forecast has been adjusted to 101.5 billion yen, with a very small reduction from FX, including the impact of price reductions due to product mix and the price impact from Enerphysis, as I mentioned earlier. Core EPS has been set at 44.7 billion yen, an increase from our previous forecast. Our free cash flow forecast has been changed from 40 billion yen to 50 billion yen, and we are paying 18.8 billion yen in annual taxes. Let's conclude the presentation on slide 24. Our overall company performance is in line with expectations due to our core open profit, and we are gradually making progress towards our management guidance. In the first half, there were large non-core items that affected our reported open profit, but these do not hinder our strategy. The exclusivity headwinds we face in 2023 are as expected, and we have been preparing for this for several years. We are confident in our portfolio and pipeline to return to growth in the coming years, and we will continue to raise funds to provide sustainable growth and competitive shareholder returns. Finally, on slide 25, our future IR events have been announced, including the Plasma-Derived Therapies conference. We hope many of you can participate in Takeda's important business units. Thank you for watching. Now, let's start the Q&A. We will accept questions until 7:15 PM Japan time. The respondents will include Christophe, Koster, Andy, along with Ramona Sequeira, President of the Global Portfolio Division, Julie Kim, President of the US Business Unit, and Furtan Milano, President of the Japan Pharma Business Unit.
Speaker 4: transcript
Speaker 4: Moving to slide 23 and our outlook for full year fiscal 2023. Based on the.
Moving to slide 23, and our outlook for full year fiscal 2023.
Based on the first half results.
Speaker 4: transcript
Speaker 4: We do not see the need to make any changes to our management guidance at this stage.
We do not see the need to make any changes to our management guidance at this stage.
Speaker 4: transcript
Speaker 4: To date, the generic erosion of Vyvanse and Azulba has been in line with our original expectations and therefore we are keeping our management guidance unchanged.
To date, the generic erosion of violence Amazon has been in line with our original expectations and therefore, we are keeping our management guidance unchanged.
Speaker 4: transcript
Speaker 4: Low single digit percentage decline in revenue, low 10 percentage decline in core operating profit, and low 20 percentage decline in core EPS, or on a cross and exchange rate basis.
Low single digit percentage decline in revenue low teen percentage decline in core operating profit and low twenties percentage decline in core EPS on a constant exchange rate basis with regard to the reported and core forecast on an actual FX basis, we have updated our epic.
Speaker 4: transcript
Speaker 4: With regard to the reported and core forecast on an actual FX basis, we have updated our FX assumptions, resulting in a 140 billion yen increase in our revenue forecast to 3.98 trillion yen.
Assumptions, resulting in a 140 billion yen an increase in our revenue forecast to $3 nine a frequent yet.
Speaker 4: transcript
Speaker 4: reported operating profit and reported EPS forecasts have been revised to incorporate the large non-core items that we booked in the first half.
Reported operating profit and reported EPS forecast have been revised to incorporate the large non core items, we booked in the first half.
Speaker 4: transcript
Speaker 4: On a core basis, our core operating profit forecast is unchanged at 1.015 trillion yen with very small upside from FX being offset by product mix, including the cost of goods impact from Xgivity and O'Fissile that I mentioned earlier.
On a core basis, our core operating profit forecast is unchanged at 1.015 trillion yen with very small upside from ethics being offset by product mix, including the cost of goods impact from excuse me the NFL official that I mentioned earlier.
Core EPS is now projected to be 447 years, an increase from our prior forecast due to a lower ashamed core tax rate are.
Speaker 4: transcript
Speaker 4: Core EPS is now projected to be 447 yen, an increase from our prior forecast due to a lower assumed core tax rate.
Speaker 4: transcript
Speaker 4: Our free cash flow forecast is unchanged at 400 to 500 billion yen and we remain committed to paying an annual dividend of 188 yen.
Our free cash flow forecast is unchanged at 400 to 500 billion yen and we remain committed to paying an annual dividend of 188 yet.
Speaker 4: transcript
Speaker 4: To close out the presentation on slide 24, I'd like to re-emphasize that total company performance on a core basis is in line with expectations and we are making steady progress towards our management guys.
To close out the presentation on slide 24.
Like to reemphasize that total company performance on a core basis is in line with expectations and we are making steady progress towards our management guidance.
Speaker 4: transcript
Speaker 4: There were some large non-core items impacting our reported operating profit in the first half, but these do not derail our strategy.
There were some large non core items impacting our reported operating profit in the first half, but these did not derail our strategy.
Speaker 4: transcript
Speaker 4: The loss of exclusivity headwinds we face in 2023 are as expected, and we have been preparing for this for many years.
The loss of exclusivity headwinds we face in 2023 are as expected and we have been preparing for this for many years, we have confidence in our portfolio and pipeline to deliver a return to growth in the near term and we will continue to allocate capital with discipline as we focus on delivering sustainable growth.
Speaker 4: transcript
Speaker 4: We have confidence in our portfolio and pipeline to deliver a return to growth in the near-term and we will continue to allocate capital with discipline as we focus on delivering sustainable growth and competitive shareholder returns. For us.
And competitive shareholder returns.
Finally on slide 25.
Speaker 4: transcript
Speaker 4: I would like to highlight our upcoming IR events, including a plasma drive therapies meeting in early December . I hope that many of you are able to participate for a deeper dive into this important business unit for Takeda. Thank you for your attention, and we can now open up for Q&A.
I would like to highlight our upcoming IR events, including a plasma derived therapies meeting in early December.
Many of you are able to participate for a deeper dive into this important business unit for Takeda. Thank you for your attention and we can now open up for Q&A.
Speaker 1: transcript
Speaker 1: That's all for today. If you enjoyed this video, please subscribe and hit the bell icon.
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Speaker 1: transcript
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Speaker 1: If you would like to ask a question, please click the 'Raise Hand' button on Zoom to let us know. If you are participating via the Japanese line, please ask your question in Japanese. If you are participating via the English line, please ask your question in English. For those listening to the live audio, you may ask your question in either language. Please note that each person is limited to two questions. We would appreciate it if you could ask all your questions at the beginning. Thank you for your cooperation. Now, for the first question, Mr. Yamaguchi from Citi, please go ahead. Mr. Yamaguchi, thank you. Now, for the next question, Mr. Yamaguchi, please go ahead. We would like you to ask about Q2 as well. Mr. Yamaguchi, thank you. You have also asked about Q2. Now, let's talk about the changes in Q2 margins. The margin for Q2 decreased over the month. There are two reasons. One is related to the product mix, as I mentioned, due to the decrease in exclusivity of high-margin products, the impact of the excellent work of the team, and the reduction due to the coronavirus. Compared to fiscal Q2 of 2022, the impact of the reduction in exclusivity and the product mix due to the coronavirus appeared. The reduction due to the coronavirus appeared in the excellent work of the team.
Speaker 1: transcript
Speaker 1: If you have any questions, please leave a comment on the summary of the Zoom button.
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Speaker 1: transcript
Speaker 1: Now everyone has at least six Strengths videos on their channel. Thank you for your attention.
Now with strong Australia, Nemo mother to sustain such tight on my much fashion is smart supertanker duchene muscular highlight this clinic by Cmos.
Speaker 1: transcript
Speaker 1: L answering The first question is from the city of Yamaguchi.
So today, what size was smaller shipping Yamaguchi San.
Months.
Hi can you hear me yes.
Speaker 5: transcript
Speaker 5: Yes. Great. Thank you. Thank you. So this is Yavani from CTE. I have two patients.
Yes, great. Thank you. Thank you. So this should have a strong city are attracted to or I have two questions.
Speaker 5: transcript
Speaker 5: The first question is regarding the margin for the Q2. I understand there are lots of exclusivity happening, but the currency is positive, the PTT is doing good.
The first question is regarding.
Regarding our margin for the Q2.
Understand there there are lots of Opex too.
It's happening, but the currency as opposed to the PDP is doing good.
Speaker 5: transcript
Speaker 5: and the Batarandi goes up, so margin of the Qt is around 25%, so which sounds below competitive Q1. So do you think this is the lower than U expectation as for the Qt response sound? What not? So that's a fast question. A second question you mentioned about the PDT margin is getting better, first time after COVID.
About R&D goes up so margin of the Q3 is around 25%, so which sounds a bit low compared to Q1.
So do you think this is still lower than your expectation that's why the Q2 sponsor.
Well not so that's the horse question a.
Second question, you mentioned about the P. D T margin is getting better.
First time off the carpet.
Speaker 5: transcript
Speaker 5: What do you think, what do you mean by the PDT margin? Is it all pretty much and talk about or Q1, Q2 or fast-half from Vietnam? Can you elaborate what is doing better on your PDT margin? Which one of the crucial factors for next fiscal year? Thank you.
Or do you think what do you mean by the Pvt margin as operating margin I'm talking about the Q O Q2, or first half compared to last year.
All right what is doing better on your PDT imagine, if which ones are a crucial boxed off for next fiscal year. Thank you.
Speaker 1: transcript
Speaker 1: Okay, thank you Yamaguchi-san. So a question on the margins and also on PDT margins specifically, so I'd like to ask Kosta to respond to those questions.
Okay. Thank you Yamaguchi San So a question on the margins and also on PTT margins, specifically, so I'd like to ask Costa to respond to those questions.
Speaker 6: transcript
Speaker 6: Right, thank you. Yamaguchi-san, thank you for your question. You specifically asked for Q2 itself. So let me just walk you through the changes to the margin question for Q2.
Right. Thank you Yamaguchi San Thank you for your question.
Typically ask for Q2 itself. So let me just walk you through the changes to the margin question for Q2 so.
Speaker 6: transcript
Speaker 6: Q2 core growth margin had declined or the quarter, mainly because of two reasons. One, as you highlighted already, the product mix. So we saw lots of exclusivity of high margin product, such as Dexcellent, Volcator, Zilva, coupled with lower COVID vaccine rates.
Q2 core gross margin had declined.
For the quarter, mainly because of two reasons one as you highlighted already the product mix that we saw loss of exclusivity of high margin products, such as the excellent velcade as zorba, coupled with lower Covid vaccine revenue.
Versus last Q.
Speaker 6: transcript
Speaker 6: versus last Q2 fiscal year 2022. In addition to that, we saw cost of goods impact of alifisal and exchivity write-offs due to the setbacks that we had. So that, that pressure on our margin for quarter two by our gross profit margin. On a core operating profit margin.
Q2 fiscal year 2022 in.
In addition to that we saw.
Cost of goods impact.
<unk> excuse me the write offs due to the setback that we had said that that put pressure on our margin for quarter two.
Gross profit margin on a.
Core operating profit margin.
Speaker 6: transcript
Speaker 6: On top of the product mix, COVID vaccine and COGS impact, we had R&D phasing, so we had a ramp up of R&D expenses, but this is phasing and it's aligned to our forecast.
On top of the the product mix Vacs private vaccine in Cogs impact we had R&D phasing. So we had a ramp up of R&D expenses, but this is phasing and it's aligned to our.
Forecast.
Speaker 6: transcript
Speaker 6: And in addition to that, we did see some wind down costume to exhibit.
And in addition to that we did see some wind down costs due to excuse me, but nevertheless on a year to date basis, we're tracking along to a plane, which is 28% cooperating profit as a total full year perspective, we're targeting 1000.
Speaker 6: transcript
Speaker 6: But nevertheless, on a year-to-date basis, we're tracking aligned to our plan, which is 28% cooperating profit. As a total full year perspective, we're targeting 1,015 billion yen.
1000, 15 billion yen again second year in a row that we exceed one trillion yen with Takeda on a cooperating profit and year to date on a run rate, where we're very much on track to delivering that.
Speaker 6: transcript
Speaker 6: Again, second year in a row that we exceed one trillion yen for Takeda on a cooperating profit and year to date on a run rate, we're very much on track to delivering that full year target. So thank you very much.
We target. So thank you very much on that question on the PBT margin.
Speaker 6: transcript
Speaker 6: on the PDT margin, what's improving, it's gross profit margins improving, as well as core operating profit.
What's improving its gross profit margins improving as well as cooperating profit is improving so we're seeing the gross profit margin improving mainly because of <unk>.
Speaker 6: transcript
Speaker 6: So we're seeing the gross profit margin improving mainly because of product mix within the portfolio.
Product mix within the portfolio.
Speaker 4: transcript
Speaker 4: But on the cooperating profit margin we're seeing significant improvements overall driven by a really efficient end to end process.
On the on the cooperating profit margin, we're seeing significant improvements overall driven by a really efficient end to end process, whether it's leveraging data digital technology throughout the PDP value chain or manufacturing capacity. So overall, we're very pleased with the performance not only on the top line.
Speaker 6: transcript
Speaker 6: whether it's leveraging data digital technology throughout the PDD value chain or manufacturing capacity. So overall, we're very pleased.
Speaker 6: transcript
Speaker 6: with the performance, not only on the top line growth for PDT, but also on its profitability. This is something that we expect to continue for many years to come.
Growth opportunity, but also on its profitability and this is something that we we expect to continue for many years to come. Thank you.
Speaker 6: Thank you. Sorry, quick one quick update on PDT. Talk about first half for Q2Q1. We see you today. So I'm looking at you today for six months. Okay, thank you. Thank you. Thank you very much. Thank you very much. Thank you very much. Thank you very much. Thank you very much. Thank you very much. Thank you very much. Thank you very much. We will return to growth. We need to happen in 24 or 25. We'll have to see. If it happens in 24, it's possible. It will be very tight. Thank you very much. Thank you very much. Thank you very much. Thank you very much. Thank you very much. Thank you very much. Thank you very much.
Speaker 5: transcript
Speaker 5: Sorry, one quick update on PDT. Talk about FASFAQ2-Q1.
Sorry quick one quick update on P. J D talk about first half for Q2.
Speaker 6: transcript
Speaker 6: This is here to date, so I'm looking at it. Oh, here to date. Class A. Yeah. Here to date, first six months. Thank you.
This is year to date, so I'm looking at year to date for six months. Okay. Thank you.
Yeah.
I think that those I must stop.
Speaker 1: transcript
Speaker 1: The next question is for Mr. Muraoka from Morgantz.
So they got pushed Simone.
On Sunday or not.
Cause I'm not.
I should muscle.
Speaker 1: transcript
Speaker 1: A couldnit you a Mo GaN stand this? Wait the M issue I for them off. I got told I must it to.
It can lead to a motor that on Sunday.
Quite the most this year.
For tomorrow.
<unk> it.
Speaker 7: transcript
Speaker 7: I know, said like you say Jo, I good to you. Your nando car was a class TER. This car like you to no by bance to are know you get about about the book anaka zo Q no tuing and I what TA? This car like you.
And I'll say it like almost hate to interface with to you unless you're in London.
Some of this stuff.
Yeah.
Q2 two.
See you know buy bonds.
I know, you'll forget ultimate Brooklyn.
It's always that's no one wants to be seen and I know about what they do in the cigar Lake.
<unk>.
Speaker 7: transcript
Speaker 7: you are eager to return to farming instead.
Well do it.
Moderator.
You're seeing the sort of all in order to you when you kind of receivable Cds.
Okay.
Speaker 1: transcript
Speaker 1: Okay, thank you Muraukisan. So a question about our return to growth. So I'd like to ask Christoph to answer.
Okay. Thank you Morocco sounds a question about our return to growth so I'd like to ask Christophe to answer this one.
Speaker 2: transcript
Speaker 2: Thank you, Marcus, and that's, you know.
Thank you Marcus.
That's you know.
Speaker 2: transcript
Speaker 2: the return to growth will happen in 2024 or 2025.
This is a return to growth will happen in 2024 or 2025.
Speaker 2: transcript
Speaker 2: That's why we are seeing in the 1024-25.
That's why we are seeing in that temperature for quantified we might be able to return to growth in 'twenty four but in any case it would be very very tight.
Speaker 2: transcript
Speaker 2: We might be able to return to work in 24, but in any case, it will be very, very tight.
Speaker 2: transcript
Speaker 2: It's very clear in 25, but in 24, it will depend on how the 23 happen fully with the vivants, especially generic erosion. So far, it's happening as planned, but things can fluctuate quite a bit. So in the near term, we are very clear that we will return to growth. Will it happen in 24 or 25? We'll have to see. If it happens in 24, it's possible, but it will be very clear.
It's very clear in 'twenty five 'twenty four it will depend on how the 'twenty three happen are fully with others of vyvanse, especially generic erosion Sofia is happening as planned but things can fluctuate quite a bit so in the naphtha them. We are very clear that we will return to growth or will it happen in 'twenty.
Slide 25, we will have.
We'll have to see if it happens in 2004, it's possible, but it would be very tight.
Speaker 7: transcript
Speaker 7: I'm sorry, I forgot to say the second question, but I won't be able to make it in time.
Cmos anymore meals like D&O suit Undisc adult smoker pneumonia I must call.
Speaker 7: transcript
Speaker 7: Thank you very much. It's the 14th of the slide,
Cmos.
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Speaker 7: transcript
Speaker 7: The pipeline proclamation is also obvious that lead lettuce is a joint routine. We also NFRC Suppose.
The pipeline.
Israel and the more data on appeal put up concept. So do you loved it.
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Speaker 1: transcript
Speaker 1: Okay, so Andy on this slide, the 2024 readouts, any more color on the timing within FY24 of these four important readouts?
Okay. So Andy on the slides the 'twenty 'twenty four readouts any more color on the timing within FY 'twenty four of these four important readouts.
Okay.
Speaker 3: transcript
Speaker 3: Just D?oration T&E, Mo Rockys and thank you. So the
Chris It's Dan.
Rochus on thank you so the.
Speaker 3: transcript
Speaker 3: So the first readouts that will come from these data will be in our rex and program for TAC-861 for both type 1 narcolepsy and type 2 narcolepsy. And those will have final data for both studies in early 2024. We've actually completed enrollment of both of those phase 2b studies. It's an eight week primary M.
So the first readouts that will come from from the data will be in our Orexin program for <unk> one for both type one narcolepsy in type two narcolepsy and those will have final data from both studies in early 2024, we've actually completed enrollment of the of both of those phase II studies.
Week primary endpoint for the study with the transition to an open label extension and I'll say that we're already planning for phase III at risk rate. We're planning for a successful data from the study based studies based on everything that we know so those would be the first that will that will come.
Speaker 3: transcript
Speaker 3: for the study with the transition to an openly playable extension. I'll say that we're already
Speaker 3: transcript
Speaker 3: planning for phase three at risk. We're planning for successful data from those studies based on everything that we know. So those would be the first that will come.
Speaker 3: transcript
Speaker 3: We also expect to see data later this fiscal year for Bezigidumab in ITP and then early in fiscal year 2024 for IgA nephropathy. And then the remaining readouts will come later in the year.
We also expect to see data.
Later this fiscal year for designate them add in <unk> and in early in fiscal.
Fiscal year 2024 for Iga nephropathy.
And then the remaining Readouts will come later in the year.
Speaker 3: Thank you very much. Now, I would like to move on to the next question. Next, we have Mr. Wakao from JP Morgan. Thank you. This is Wakao from JP Morgan. I would like to ask two things about NT disease. The first is the outlook for NT disease for the next fiscal year. For the current fiscal year, the sales plan for NT disease has been revised downward. Looking at this situation, should we also be cautious about the outlook for the next fiscal year, or can we expect a recovery trend from the next fiscal year with the contribution of SC? This is the first question. The second question is about the current situation of NT disease. Although you have explained various things this time, I don't think you touched on the situation of the competition. I think the competition is quite fierce and they are actively marketing. If there are any changes in the competitive situation, please let us know. That's all. Thank you. So some questions on NT disease specifically the outlook for next year, expectations for subcutaneous, and then some more detail on what we are seeing on the ground including competition. So I'd like to ask Christophe to say a couple of comments at the beginning and then maybe hand over to Julie to give more detail, particularly on the US market. Okay, thank you, Wakao-san. I think obviously we'll give next year guidance in May next year, but I think there are very two important parameters that are important to consider. One is that the launch of the sub-Q will certainly be leveraged overall. So we expect a very significant positive impact on the overall brand. I mentioned earlier that around 35 to 40% of the US market is a sub-Q formulation market. So it will allow us to compete in this segment that we didn't have access to in the past. So that's one. And two, it will be very interesting to see how the overall market is evolving. We believe that new patient treatment initiation is still quite low. The market growth in volume has been quite lower than what we expected. We know that we are not at the pre-COVID level in terms of new treatment initiations. It will be very interesting to see if things will remain like that or if we will see a rebound. So overall, I would suspect that we will see an increased growth. I will let Julie mention the situation regarding the competition. Obviously, there is a lot of competition. We can zoom on the US. But before that, I would like to mention that Antivio is also growing very well outside of the US, in Europe , in China, in Japan. Julie, perhaps you can comment on the competition. Yes, thanks, Christophe. And thank you for the question, Wakao-san. In terms of the competition in the US, as you've rightly pointed out, there is increased competition through new entrants. And even yesterday, there was an announcement of a new entrant from Celtrion. So we continue to see multiple different mechanisms of actions entering into the IBD space. But Antivio continues to be the only gut-selective MOA. And it continues to be the market share leader in terms of overall bione share as well as overall IBD market share. So this is an area where we will continue to emphasize the benefits of Antivio in the IBD space. And with the launch of the subcutaneous formulation, Antivio PEN were quite confident in our ability to continue to support Antivio growth in the US despite new entrants coming in.
Okay.
Speaker 1: transcript
Speaker 1: Thank you. Let's move on to the next question. The next question is from JP Morgan's Wakao-sama.
Hi, I got those Imus, So did you want to.
So when you consolidate all my message to you.
J P Morgan Norwalk Osama.
And I was kind of our Cmos.
Speaker 8: transcript
Speaker 8: More there's a lot of TR interview. seet of starts CT is a SPO, So mayga to interview, or right King on door ISA the can' there. Our interview a video. G Co hor uses very much ST.
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<unk> senior director dataset.
<unk> got to.
So entyvio <unk> doshi that's it.
Can you cause to our interior, though as you know they take a whole cohort juices had a must stop.
Speaker 8: transcript
Speaker 8: If this was my bluetooth application, I can release it using only Naturally seeks away over Alexa, Thank you for your attention.
Hello, Joe killed me must alrighty mall, and torched assessing joining the whole body of additional cost much glass like gorilla is casino and Coke and Monster High school and the new Hydro <unk> Doshi initial cost.
Speaker 8: transcript
Speaker 8: This is the first point. The second point is about the current situation of the job interview. You explained a lot of things this time, but I don't think I was able to touch on the situation of the competition. I think the competition is quite intense right now. I think they are actively doing marketing, but if there is any change in the competition situation, I would like you to tell me.
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Speaker 1: transcript
Speaker 1: Thank you. So some questions on Antivio, specifically the outlook for next year, expectations for subcutaneous, and then some more detail on what we're seeing on the ground, including competition. So I'd like to ask Christophe to say a couple of comments at the beginning, and then maybe hand over to Julie to give more detail, particularly on the US market.
Thank you so some questions on Entyvio, specifically the outlook for next year expectations for subcutaneous and then some more detail on what we're seeing on the ground including competition. So.
So I'd like to ask Christophe to say a couple of comments at the beginning and then maybe hand over to Julie to give more detail, particularly on the U S market.
Speaker 2: transcript
Speaker 2: Okay. Thank you, Wakao-san. I think, well, obviously, we'll give next year guidance in May next year, but I think there are very two important parameters that are important to consider. One is that...
Okay. Thank you with Amazon.
I think obviously, we'll give our nextgen guidance in May next year.
I think they are very two important parameters that are important.
Important to consider one is that the launch of the sub Q will separately.
Speaker 2: transcript
Speaker 2: the launch of the sub-Q will certainly be leveraged overall. So we expect a very significant positive impact on the overall brand. I mentioned earlier that around 35% to 40% of the overall brand will be leveraged. And we expect a significant positive impact on the overall brand. I mentioned earlier that around 35% to 40% of the overall brand will be leveraged.
Billing range overall, so we expect a very significant positive impact on the overall brand I mentioned earlier up to around 35% to 40% of the U S market is a sub Q formulation markets, which will allow us to compete in this segment that because you don't have access.
Speaker 2: transcript
Speaker 2: of the U.S. market is a sub-Q formulation market. So it will allow us to compete in this segment that we didn't have access to in the past. So that's one. And two, it will be very interesting to see how the overall market is evolving. We believe that new patients.
As to in the past so that's one and two it would be very interesting to see how the overall market is evolving.
We believe that the new patient treatment initiation as children are quite low.
Speaker 2: transcript
Speaker 2: treatment initiation is still quite low. The market growth in volume has been quite lower than what we expected. We know that.
The market growth in volume has been quite lower than what we expected.
We know that we are not at pre COVID-19 levels changing demo new treatment initiations with it would be very interesting to see if.
Speaker 2: transcript
Speaker 2: We are not at the pre-COVID level in terms of new treatment initiations. It will be very interesting to see if things will remain like that or we will see a rebound.
We remain like that or we will see a rebound so overall.
Speaker 2: transcript
Speaker 2: So overall, I would suspect that we will see an increased growth. I will let Julie mention the competition. Obviously, there is a lot of competition. We can zoom on the US. But before that, I would like to mention that Antivirus is also growing very well outside of the US, in Europe , in China, in Japan. Julie, perhaps you can comment on the.
I would suspect that we will see an increase grow with that I will let Julie mentioned.
<unk> oriented cruiser competition, obviously, there is a lot of competition, we can zoom on the U S, but before that I would like to mention that on Tvs or so growing very well outside of the U S in Europe, and China and.
In Japan, Judy, perhaps you can comment on the competition.
Speaker 9: transcript
Speaker 9: Yes, thanks, Christophe, and thank you for the question, Juan Carlos. In terms of the competition in the U.S., as you've rightly pointed out, there is increased competition through new entrants, and even yesterday, there was an announcement of a new entrant from Celtrion. So we continue to see multiple different mechanisms of action entering into the IBD space, but Antivio continues to be the only gut-selective MOA, and it continues to be the market share leader in terms of.
Thanks, Christopher and thank you for the question was on some of the competition in the U S. As you've rightly pointed out there is increased.
Competition for new and transform even yesterday there was an announcement.
Of our new entrants from cell town. So we continue to see multiple different mechanisms of action.
Entering into the IBD space, but in Korea continues to be the only that selective MLA and continue.
Market share leader in terms of overall.
Speaker 10: transcript
Speaker 10: by only share as well as overall IBD market share. So this is an area where we will continue to emphasize the benefits of interview in the IBD state. And with the launch of the subcutaneous formulation and TVO pen, we're quite confident in our ability to continue to support interview growth in the US despite new entrance coming in.
I am sure as well as alcohol IBD market share. So this is this is an area where we will continue to.
Emphasize.
Politics, and TDI MDI BT sport.
With the launch of the subcutaneous formulation in kidney upon we're quite confident in our ability to continue to support and kidney alcohol in the U S. Despite.
New entrants coming in.
Speaker 10: Yes, I understand well. Thank you very much. Now, I would like to move on to the next question. I would like to move on to the next question. I would like to move on to the next question. Now, I would like to move on to the next question. Now, I would like to move on to the next question. Now, I would like to move on to the next question. Now, I would like to move on to the next question.
Oh Yokokohji bus shuttle them all thank you.
Speaker 1: transcript
Speaker 1: Thank you very much. Jefferies, Steve Barker.
I think that those I must stop so does that so you know so many its really tied to one way Moss.
Jeffrey Steve Barker.
Please on mute and ask your question.
Speaker 11: transcript
Speaker 11: Yes Steve Barker here. Thanks very much for picking my questions. I have two questions for Andy related to your narcolepsy candidate, Tack 861. Specifically, I wanted to ask about the phase one results that were presented at world sleep this week.
Yes, Steve Barker here, thanks, very much for taking my question.
Two questions for Andy.
Related to your narcolepsy candidate Tak 861, specifically I wanted to ask about the phase one results that were presented at World sleep. This week Firstly could you discuss the doses that were tested in phase one in the context of the phase III program and secondly.
Speaker 11: transcript
Speaker 11: Firstly, could you discuss the doses that were tested in phase one in the context of the phase two program? And secondly, are you concerned that TAC 861 might be at a commercial disadvantage?
Are you concerned that Tac 861 might be at a commercial disadvantage if it needs to be dosed twice per day.
Speaker 11: transcript
Speaker 11: if it needs to be dose twice per day. The context of the second question is, of course, the data presented on the Alkermes orexin agonist, which looks like it can be developed as a once-per-day therapy.
The context for the second question is of course, the data presented on the <unk> Orexin agonist, which looks like it can be developed as a once a day therapy.
Yeah.
Yeah.
Speaker 3: transcript
Speaker 3: Hi, Steven. I'll take the first question and then I'll ask Ramona to chime in if she can on the commercial positioning of a once versus a twice daily dosing. So the phase 1b data that we presented at the sleep conference just this week was really very small numbers, really proof of concept. The doses that we've used in our phase 2b studies are significantly lower than what you saw this week.
Hi, Steven I'll take the first question and then I'll ask Ramon to chime in if he.
If she can on the on the commercial positioning of a once versus twice daily dosing. So.
So the phase <unk> data that we presented at the <unk> Conference just this week.
Really.
Small numbers really proof of concept the doses that we've used in our phase <unk> studies are significantly lower than what you saw this week.
Speaker 3: transcript
Speaker 3: And then lastly, I'll say that, you know, we haven't decided on our dosing regimen yet for our phase three program. That's something that we'll decide after we see our full phase 2B data. And I think that we have to be, you know, cautious when we look at any data set, ours or competitors from small phase one B studies in terms of understanding what administrations, gattles will look like.
Then lastly, I'll say that.
We haven't decided on our dosing regimen, yet for a phase III program, that's something that we'll decide after we share for phase <unk> data and I think that we have to be cautious when we looking at any data set ours or competitors.
Some small phase <unk> studies in terms of understanding what administration scandals will look like.
Ramona.
Speaker 9: transcript
Speaker 9: Yeah, Andy, I can chime in on the efficacy and, you know, we had a very large team at the sleep conference this week and are very excited about the erection franchise that we have at to Keta for 861. We still believe it's going to be the first in class and the best in class to treat our call up see and as we do research with physicians and patients really around the world as you know, most importantly in the US as well.
Yeah, Andy I can I can chime in on the efficacy and and you know we had a very large team at their sleep conference. This week and are very excited about the orexin franchise that we have at Takeda for 861, we still believe it's going to be the first in class and the best in class to treat narcolepsy and as we do research with physicians and <unk>.
<unk> really around the world and as you know most.
Most importantly in the U S as well.
Speaker 9: transcript
Speaker 9: There is such a high need for better treatment options to really help people live a more functional life.
If there is such a high need for better treatment options and to really help people live a more functional life with narcolepsy and so it's always going to be a trade off with the dosing and the actual functionality that we can get and so we are very confident that whatever profile. We go for with dosing will.
Speaker 9: transcript
Speaker 9: with narcolepsy. And so it's always gonna be a trade-off with the dosing and the actual functionality that we can get.
Speaker 9: transcript
Speaker 9: And so we are very confident that whatever profile we go for with dosing will be to really maximize functionality in these patients. And as Andy said, it's early days to say now exactly how we're going to plan to do that, we're very confident in our target product profile for a.
B to really maximize functionality in these patients and as Andy said, it's early days to say now exactly how we're going to plan to do that but we're very confident in our target product profile for 861.
Speaker 11: transcript
Speaker 11: Thanks. Just one quick follow-up regarding the safety. So you were testing very last doses in this first, in this phase one versus what you are testing in phase two. And the safety profile looks very good. Does that give you, how do you, does that improve your confidence about the safety of this?
Thanks, just one quick follow up regarding the safety. So we're testing very large doses in this this and this.
Phase one versus what you are testing phase two.
The safety profile looks very good does that give you how do you does that improve your confidence about the safety of the assessment.
Speaker 11: The more experience we have, the stronger we feel about the safety profile of HX1. And I will just reiterate something I said during the presentation, which is that we have now enrolled approximately 180 patients in the two phase 2B studies. We have obviously been very cautious around all safety parameters, especially liver function tests. We have an independent data safety monitoring board that's been tracking, and we haven't seen any signals consistent with liver toxicity. And it's very consistent with the margins that we have and the doses that we're using. So we feel quite good about the overall safety and tolerability profile at this point. Thank you. Thank you very much. The next question is from Mr. Hashiguchi of Daiwa Shoken. Thank you very much. The question is about the data for phase 2 of the TAC-279 infectious joints. I saw the abstract presentation at ACR. Compared to the test data for the same application of SORTEX, I feel that the effectiveness has not changed much. I think that there may be more TAC-279 in high doses, about the same in low doses. It seems that the patient's background is different, so could you tell us how to interpret this test data? As a doctor, I would like you to tell us how you think about the competitiveness of TAC-279 again. Thank you, Hashiguchi-san, for the question. So a question on the TAC-279 psoriatic arthritis phase 2 abstract that was recently published. Andy, your thoughts on that? Sure. Thanks, Chris, and thanks, Hashiguchi-san. So not to steal the thunder from the presentation that's coming up in just a few weeks, let me just make a few high-level comments. The first is that it's very important to look at the study differences between our study and previous studies in psoriatic arthritis. And in particular, the timing of the endpoint. So we're looking at a 12-week time point, and most other studies look at a 16-week endpoint. It's also important to look at the differences in the underlying patient population, and we'll discuss some of those differences at the presentation next month. And then the third point I'll make is that the psoriatic arthritis is often misunderstood in terms of its disease presentation. It's actually in a continuum with psoriasis. So most patients with psoriatic arthritis have skin lesions, plaque. And most patients with psoriasis actually end up developing some joint problems. And so the two diseases are highly related. And so when we're looking at endpoints in psoriatic arthritis, we're looking at both joint endpoints and skin endpoints.
The more the more experience we have them.
Speaker 3: transcript
Speaker 3: The more, Steven, the more experience we have, the more, the stronger we feel about the safety profile of 861, and I'll just reiterate something I said during the presentation, which is that we've now enrolled 180 patients approximately in between the two phase 2B studies. We've obviously been very cautious around all safety parameters, especially liver function tests, and we have an independent data safety monitoring board that's been tracking, and we haven't seen any signals consistent with liver toxicity, and it's very consistent with the margins that we have.
The stronger we feel about the safety profile of 861, I'll just reiterate something I said during the presentation, which is that we've now enrolled 180 patients.
Proximately in between the.
The two phase <unk> studies with that we've obviously been very cautious around all safety parameters, especially liver function tests and we have an independent data safety monitoring board thats been tracking and we haven't seen any any signals consistent with liver liver toxicity and its very consistent with that.
At the margins that we have.
Speaker 3: transcript
Speaker 3: and the doses that we're using. So we feel quite good about the overall safety and tolerability profile at this point.
The exposure and the doses that we're using so we feel quite good about the overall safety and Tolerability profile at this point.
Thank you.
Speaker 1: transcript
Speaker 1: I got. I must stop sort up so you not wish more. They are shookk and not how she could sum up your conization.
How do you get those I'm, a stock split it out to small dialogue or cannot actually with some of them.
I was wondering I suppose.
Speaker 12: transcript
Speaker 12: Shite, who was informed. Not going there. Then, that's the reply on a war
How soon after the authority that go with that.
First of all popcorn you don't actually know.
That's a concept not that it's not there.
Okay.
Speaker 12: transcript
Speaker 12: Do you think ACR structures play a main role for theYoung influenced unveiling?
Yeah.
Then I'll hop there are no other structural heart class must stop.
Speaker 12: transcript
Speaker 12: Is So they could do know one logit: is you also know skin or data to what could have it day?
Yeah, So I'll take a stab at all or does it make you also know.
I don't know that that the market out there.
Speaker 12: transcript
Speaker 12: I feel that the effectiveness does not change much.
Yeah of course, there are a lot of Colorado and all kinds of muscle.
Yeah, you're right there's a law.
Speaker 12: transcript
Speaker 12: I think it's about the same in low-capacity, and in high-capacity, the TAC-279 may be a little more.
They order or the one that has a good eye coiled or that the popcorn and you're not doing a whole lot of costs that are already knock on most of the night when weighing method.
Speaker 12: transcript
Speaker 12: The patient's background seems to be different, so could you tell us how to interpret the data for this test? As a speaker, I would like you to tell us how you think about the competitiveness of TACC279.
All kinds of high tier.
So if all of this in all the.
<unk> not at all on their own prior soccer C. So everybody you know catino shipper that can lessen the so-called Osaka. They are permitted Cochrane and Alto, California, Colorado, and Oklahoma that call and say Oh My God.
Speaker 1: transcript
Speaker 1: Thank you, Hachiguchi-san, for the question. So a question on the 7-9, sorry, I think arthritis phase two abstract that was recently published. And here your thoughts on that?
Thank you Sam for the question. So a question on the 279, sorry, I think arthritis phase two abstract that was recently published.
And if your thoughts on that.
Speaker 3: transcript
Speaker 3: Thanks, Kristen. Thanks, Haseguchi-san. So, not to steal the thunder from the presentation that's coming up in just a few weeks, let me just make a few high-level comments. The first is that it's very important to look at the study differences between our study and previous studies.
Sure Thanks, Chris and thanks, Hansa Gucci soon so.
Not to steal the Thunder from the presentation, that's coming up in just a few weeks, let me just make a few high level comments that versus debt.
It's very important to look at the study differences between how our study in previous.
Speaker 3: transcript
Speaker 3: Previous studies in psoriatic arthritis and in particular the timing of the endpoint. So we're looking at a 12 week time point and most other studies look at a 16 weekend point. It's also important to look at the differences in the underlying patient population and we'll discuss some of those differences at the presentation next month.
Previous studies in Psoriatic arthritis, and in particular, the timing of the endpoints that we're looking at a 12 week time point than most other studies look at a 16 week endpoint and it is also important to look at the differences in the underlying patient population and we will discuss some of those differences at the presentation next month.
Speaker 3: transcript
Speaker 3: And then the third point I'll make is that the psoriatic arthritis is often misunderstood in terms of its disease presentation. It's actually in a continuum with psoriasis. So most patients with psoriatic arthritis.
And then the third point I'll make is that the psoriatic arthritis is missed.
Is often misunderstood in terms of its disease presentation, it's actually in the in a continuum with psoriasis. So most patients with psoriatic arthritis have skin lesions plaque and most patients with psoriasis actually end up developing some some drilling problems and so the two diseases are highly related and so when we're looking at.
Speaker 3: transcript
Speaker 3: skin, lesions, plaque, and most patients with psoriasis actually end up developing some joint problems. And so the two diseases are highly related. And so when we're looking at endpoints in psoriatic arthritis, we're looking at both joint endpoints and skin endpoints.
Endpoints in Psoriatic arthritis, we're looking at both join endpoints and skin endpoints, what what we've learned through multiple mechanisms in this in these pack that inhibiting cytokines IL 12, IL 23, interferon is that the dose response characteristics on the joint endpoints tend to be fair.
Speaker 3: What we have learned is that through many machines, we have learned about a wide variety of mechanisms to resist the bacteria contained in this side keen, IL-12, IL-23, and interferon. The dose-response characteristics are that the tissue endpoints are quite flat. This is something we always see. We expect to see a big discrepancy from our competitors. We will provide detailed information about these data during the presentation. Thank you. Thank you for the question. Next, we would like to take a question from the floor. Mr. Mike Nidolkavich, please answer. Thank you for your answer. My question is, it is a bit surprising to hear about the impact of the coronavirus. It might be difficult to draw influences from other factors. Will the validation and verification of treatments and other therapeutic categories indicate the impact of future pandemics? If it has to be so, what differences do you feel about IBD? And what is your best answer regarding the normalization we can see? Next, about the subcutaneous announcement. I know, but it is very early. What early indicators do you see regarding subcutaneous products heading towards high service guidance in management? Also, what do you think about the headwinds regarding the competition and the impact of the coronavirus you explained? Thank you, Mike. Julie, could you answer that question? For each question. Yes, of course. Thank you for the question, Mike. Regarding the comment on the suppression of diagnoses, we are thinking about the claims data. There are several claims databases that can be seen in America. For example, regarding the coronavirus, one shows an 8% to 10% decrease in diagnoses that can be seen in America. Another shows a 20% decrease in diagnoses over 12 months regarding claims data. So, we are seeing a decrease in diagnoses after corona. We received questions about other areas. We looked at the numbers in other areas. I don't have specific numbers off the top of my head, but it wasn't at a high level of claims disease, but we saw similar numbers in other areas as well. We have a theory about the overall suppression of infection spread due to corona, but we are closely monitoring it. We are working on a safe invader space of action. The invader space is an opportunity to demonstrate the value of our invader space.
Speaker 3: transcript
Speaker 3: What we've learned through multiple mechanisms that inhibit these cytokines, IL-12, IL-23, interferon, is that the dose response characteristics on the joint endpoints tend to be fairly flat. That's something that we consistently see across therapy.
Flat, that's something that we consistently see across across therapies, where we're expecting to see significant differentiation from our competitors is again going to be on the skin endpoints. So youll see more of those data will provide some additional.
Speaker 3: transcript
Speaker 3: We're expecting to see significant differentiation from our competitors is again going to be on the skin end point.
Speaker 3: transcript
Speaker 3: So you'll see more of those data will provide some additional details around those data when they're in the presentation.
Details around those data during the presentation.
Yeah, a couple of minor stuff.
Speaker 1: transcript
Speaker 1: Thank you very much for the question. Okay, so next we'd like to take a question from Kowin. Mike Midokovic, please unmute and ask your question.
Thank you very much for the question.
Okay. So next we'd like to take a question from Colin Mike Nick Kovich. Please on mute and ask your question.
Speaker 13: transcript
Speaker 13: Thank you for the question. My question is on Antivio. It's a bit surprising to hear that COVID is still measurably affecting IBD diagnoses and treatment rates. And I imagine it's difficult to tease that impact out from other factors. So I'm curious, are you seeing that diagnosis and treatment and other therapeutic categories are showing a lingering effect of the pandemic? And if not, what do you think is different about IBD? And what is your best guess at what we might see normalization?
Thank you for the question My question is on Entyvio.
It's surprising to hear that Covid is still measurably affecting IBD diagnoses and treatment rates and I imagine it's difficult to tease that impact out. Some other factors. So I'm curious are you seeing that diagnosis and treatment in other therapeutic categories are showing a lingering effect of the pandemic.
If not what do you think is different about IBD and what is your best guess at when we might see normalization.
Speaker 13: transcript
Speaker 13: And then on the subcutaneous launch, I know it's very early, but I'm curious if you see any early indicators that the subcutaneous product will push Intivio toward the higher end of management's peak sales guidance.
And then on the subcutaneous launch I know its very early but I'm curious if you see any early indicators that the subcutaneous product will push entyvio toward the higher end of managements peak sales guidance or do you think that headwinds such as the competition you described and the lingering effects of Covid might cause you to lean more cautiously.
Speaker 13: transcript
Speaker 13: Or do you think that headwinds such as the competition you described and the lingering effects of COVID might cause you to lean more cautiously?
Speaker 1: transcript
Speaker 1: Thanks, Mike. Julie, would you like to answer that question or those questions?
Thanks, Mike Judy would you like to answer that question all those questions.
Yes sure.
Speaker 9: transcript
Speaker 9: Thanks Mike for the questions. In terms of the comments around the suppression of diagnosis, what we...
Now for the questions.
Questions in terms of.
The comments around the suppression of diagnostics.
Speaker 9: transcript
Speaker 9: We're looking at is in terms of claims data, there are a number of different claims databases that youth can.
We're looking at is in terms of claims data there are a number of different claims database and you can see in the U S.
Speaker 9: transcript
Speaker 9: see in the US to do the communication. And when we look at, for example, Crohn's disease in particular across two different claims databases in the US, there's a roughly one shows, 8 to 10% decline in diagnosis.
And when we look at for example, crown for beef in particular across two different claims databases in the U S. There's a roughly a year.
One shows 8% to 10% decline in diagnostics.
Speaker 9: transcript
Speaker 9: and Crohn's disease in particular, and the other shows closer to 20% decline in diagnosis in the last.
In Crohn's disease in particular, and the other shows closer to 20%.
Decline on diagnosis in the last 12 months that.
Speaker 9: transcript
Speaker 9: that we have in terms of the claims data. So that's why we're saying that the diagnosis rates are still being impacted.
But we have in terms of the claims data. So that's why we're saying that the diagnosis rates are still being impacted.
Speaker 9: transcript
Speaker 9: post-COVID. Now, you asked about other areas. So we did take a look at a number of other areas and while I don't have the specific numbers on the top of my head, we did see similar suppression, although not at the high level of Crohn's disease, but we did see similar suppression and diagnosis in a few other areas as well.
Post Covid now you asked about other areas. So we do take a look at a number of other areas and while I don't have the specific numbers off the top of my head we did see similar suppression, although not at the high level of.
Of Crohn's disease that we did see similar suppression in diagnosis and a few other areas as well so not quite sure why there are some theories out there in terms of the depression.
Speaker 9: transcript
Speaker 9: So not quite sure why, you know, there are some theories out there in terms of the suppression of inflammation overall because of COVID, but it's something that we are keeping a close eye on and continuing to monitor.
The passion of information over all because of Covid.
Something that we are keeping a close eye on continuing to monitor we're focusing on what we can focus on in terms of.
Speaker 9: transcript
Speaker 9: We're focusing on what we can focus on in terms of supporting the need for treatments based on the mechanism of action of Antivio and our continued
Supporting the need for a.
Treatment.
The mechanism of action of Entyvio and our continued.
Speaker 9: transcript
Speaker 9: demonstration of safety in the IBD space.
Demonstration of safety in.
In the IBD.
Speaker 9: transcript
Speaker 9: And so the subcutaneous pen is another opportunity for us to.
And for the subcutaneous pen is another opportunity for you.
Speaker 9: transcript
Speaker 9: to demonstrate the value of Entivio in IBD, and we're very excited about that.
<unk> demonstrates the value.
Danielle in IBD.
Speaker 9: I think I covered all of them, Chris, but if I'm in something, please. I think there's a question on peak sales, maybe, Christophe, if you'd like to jump in on the peak sales and how subcue impacts the potential. Thank you, Mike, for the question. Well, when we look at the interview positioning, it's the market share that the interview has, especially for bio-nave patients, combined with the loan from the interview pen, combined with the growth of the interview, actually also outside of the US. We are very much confident about our peak estimate of between $7.50 and $9 billion. Actually, if you do the math, compared to our current situation, our current revenue, in 2023, it will require a peak of $7.50 to $9. That's equivalent to a carrier between $4.00 and $6.00 for the product. So we feel it's completely achievable, considering the strength of the interview profile, as well as the loan from the pen. Thank you. Thank you, Mike. Okay, next question we'd like to call upon Mickey Sogi from Bernstein. Please unmute and ask your question. Thank you. I also have a question regarding the interview. I understand that you are expecting them to be a new growth driver for this product. But I also like to understand the source of business for the subcutaneous at the formulation. I imagine that the majority of the sort of business is coming from existing interview patients, and potentially the additional growth will come from new patients. Is that a right understanding? And also, when you say 30% to 40% of the IVD patients will be on SC. So is this something additional? Is this, or just, you know, it's just a replacing being a current at the market? Thank you. So a question about the source of business for interview subcutaneous. Perhaps I'd like to ask Ramona to comment on experience that we've seen in markets where we've already launched the subcutaneous device in Europe , of course, one example. And then if Julie has anything to add after that, please jump in Ramona. Yes, absolutely. Hi, this is Ramona here. So, you know, as we look at launching the subcue in the US and take the learning from what we've seen when we've launched the subcue in a number of markets in Europe now and are launching another part of the world, and including Japan. There's two things that happen. One is we are able to go to new customers. So if you think about the US, we've got it as well as Europe and other markets, we've got customers that are heavy infusion prescribers. But we've got other customers that aren't as linked to infusion clinics and tend to prescribe much more subcue. Our focus has been more on the infusion providers at this stage to this stage in interview life cycle. As we bring the subcue out, it gives us new customers, new providers to go to, and that allows us to access new patients. So that's where we've seen a list around the world as we brought the subcue out in accessing these new providers and new patients that are new to the franchise. On the other side, we also have some cannibalization of existing patients. So there, you know, now we become the, you know, the only product really that has both subcue and IV options of really excellent pen, you know, along with all the other benefits of interview, got selective long term safety and efficacy data and really an ideal first choice when conventional therapies fail. And so we do see some patients now that would be on the IV switching to the subcue. That ends up being that neutral to us, but it just gives more options for patients now who want to save the interview family and stay on interview and have different different options for taking it. Thank you. Thank you.
Thinking about that.
Speaker 9: transcript
Speaker 9: I think I covered all of them, Chris, but if I missed something, please.
I think I covered all of them, Chris, but if I knew something please.
Speaker 1: transcript
Speaker 1: I think there's a question on peak sales. Maybe Christoph, if you'd like to jump in on the peak sales and how sub-q impacts the potential.
I think there was a question on on peak sales, maybe Christophe if you'd like to jump in on the peak sales and our sub Q.
Impacts the potential.
Speaker 2: transcript
Speaker 2: And thank you, Mike, for the question. Well, when we look at Ontivio positioning, and it's the market share that Ontivio has, especially for bio-naive patients.
Thank you Mike for your question.
When we look at on.
On to your positioning on this.
It's a market share that on television has especially for bio naive patients combined with the launch of the <unk> pen combined with the growth of anterior luxury also outside of the U S. We are very much confident about our PK estimate of between $7 $5 9 billion USD.
Speaker 2: transcript
Speaker 2: Combined with the launch of the Antivio pen, combined with the growth of Antivio actually also outside of the US, we are very much confident about our peak estimate of between $7.5 or $9 billion US dollar. Actually, if you do the math, compared to our current situation, our current revenue in 2023,
Actually if you do the math.
Compared to the Corona situation, our chrome to revenue in 2023.
Speaker 2: transcript
Speaker 2: it will require a peak of 7.5 to 9. That's equivalent to a carrier between 4 and 6.
It will recall each with a peak of seven five to nine that's equivalent to a caveat between four and six.
Speaker 2: transcript
Speaker 2: for the product. So we feel it's completely achievable, considering the strength of the, of the anti-viprofile, as well as the launch of the pen.
For other products, so we feel it's completely achievable.
Achievable considering the strength of their.
<unk> profile as well as the launch of the pen.
Thank you.
Thank you.
Thank you Mike.
Speaker 1: transcript
Speaker 1: Thank you, Mike. OK, next question we'd like to call upon Miki Soggy from Bernstein. Please unmute and ask your question.
Next question, we'd like to call upon Vicki Soggy from Bernstein. Please on mute and ask your question.
Speaker 3: transcript
Speaker 3: Thank you. I also have a question regarding the interview. So I understand that you know the you are expecting them, the subcue to be a new growth driver for this product. But I also like to understand in a source of business for the subcutaneous, you know, the formulation. Imagine that, you know, the in a majority of the sort of business is coming from existing interview patients.
Thank you I also have a question regarding the MTV era, so that I understand that in a day that you were expecting them dam the sub acute to be a new growth driver for.
This product, but I also like to understanding the source of business for the subcutaneous.
Formulation I imagine that there are and the majority of our business is coming from existing NPV of patients and potentially add more add that additional growth will come from.
Speaker 14: transcript
Speaker 14: and potentially add more additional growth will come from
New patients is that the right understanding and also when you say, 30% to 40% of that the IBD patients will be on SC. So.
Speaker 14: transcript
Speaker 14: transcript
Speaker 14: I needy patients will be on as she so is this something additional is this or just you know it's just a replacing being the current at the market.
Is something additionally, this or just you know it just replacing the current ad market.
Speaker 1: transcript
Speaker 1: Thank you. So a question about the source of business friend to the subcutaneous. Perhaps I'd like to ask Ramona to comment on experience that we've seen in markets where we've already launched the subcutaneous device in Europe , of course, one example. And then if Julie has anything to add, after that, please jump in. Ramona.
Thank you. So a question about the the source of business for Entyvio subcutaneous, perhaps I'll like to ask Ramon to comment on experience that we've seen in markets, where we've already launched subcutaneous device in Europe is of course. One example, and then if Julie has anything to add after that please jump in Ramona.
Speaker 15: transcript
Speaker 15: Yes, absolutely. Hi, this is Ramona here. So, you know, as we look at launching the sub-Q in the US and take the learnings from what we've seen when we've launched the sub-Q in a number of markets in Europe now and are launching another part of the world, including Japan. There's two things that happen. One is we are able to go to new customers. So if you think about the US, we've got, as well as Europe and other markets, we've got customers that are heavy infusion prescribers.
Yes, absolutely hi, this is ramon here so.
As we look at launching the sub Q in the U S and take the learnings from what we've seen when we've launched the sub Q and a number of markets in Europe now and are launching in other parts of the world and including Japan, and there's two things that happened. One is we are able to go to new customers. So if you think about the you asked we've got.
As well as Europe and other markets. We've got customers that are heavy infusion prescribers, but we've got other customers that arent as linked to infusion clinics and tend to prescribe much more sub team. Our focus has been more on the infusion providers at this stage to this stage and in kidney or lifecycle as we bring the sub Q and it gives us new.
Speaker 15: transcript
Speaker 15: but we've got other customers that aren't as linked to infusion clinics and tend to prescribe much more sub-Q. Our focus has been more on the infusion providers at this stage, to this stage in Intibio's life cycle. As we bring the sub-Q out, it gives us new customers, new providers to go to, and that allows us to access new patients. So that's where we've seen a lift around the world as we've brought the sub-Q out in accessing these new providers and new patients that are new to the franchise.
Customers new providers to go to and that allows us to access new patients. So that's why we've seen a lift around the world as we've got the sub Q out in accessing these new providers and new patients that are new to the franchise.
Speaker 15: transcript
Speaker 15: On the other side, we also have some cannibalization of existing patients. So there, you know, now we become the, you know, the only product really that has both sub-Q and IV options, a really excellent pen, you know, along with all the other benefits of Antivio, gut selective, long-term safety and efficacy data, and really an ideal first choice when conventional therapies fail.
On the other side, we also have some cannibalization of existing patients. So they're now we become the you know the only product that has both sub Q and IV options of really excellent pen along with all the other benefits of Entyvio gut selective long term safety and efficacy data and really an ideal first choice when conventional.
Therapies fail and so we do see some patients now that would be on the IV switching to the sub Q that turns out that ends up being net neutral to us, but it just gets more options for patients now and who want to stay in the <unk> family and stay on Entyvio and have different at different options for taking it. Thank you.
Speaker 15: transcript
Speaker 15: And so we do see some patients now that would be on the IV switching to the sub-Q. That ends up being net neutral to us, but it just gives more options for patients now who want to stay in the Antivio family and stay on Antivio and have different options for taking it. Thank you.
Thank you.
Speaker 15: Thank you very much. Since we are getting close to the end of the call, the next question will be our final question. So I'd like to call upon Ueda-san from Goldman Sachs, Ueda-san. I would like to thank you for your time. I would like to thank you very much for your time. I would like to thank you very much for your time. Thank you, Ueda-san for that question. So a question around our business development plans. First of all, in oncology to supplement the portfolio and then looking at the pipeline, which phases, which therapeutic areas. I'd like to ask Christophe to comment on this. Thank you, Ueda-san, for the question. So first, I would say that we are not looking, we're just reconfirmed to everyone that we are not looking at a larger menu for scale purpose. We are very competitive in all the key countries where we operate. So we don't have a scale or a competitive issue in that regard. So it's all about the portfolio pipeline, so targeted BD. On oncology, if we can bring new assets like Fritz Aklav, Fritz Aklav, we just in license, that would be terrific. So we are looking at this type of this to complement our portfolio. We have a very attractive pipeline, but it's more mid-stage. So many of these products in our pipeline will be launched toward the end of the decade. So if we can bring more assets to enrich our portfolio, we'll do. And we follow, in fact, roughly the same approach across the therapy area. Obviously, we are leader in the GI space, so if we can bring other assets, we'll do. We shouldn't forget that we have a very strong position in rare disease, in LSB disease, so we are looking at that. In placement of the right therapies, there is not much to do, so it's really about making our portfolio and pipeline more competitive. So I think we are quite agnostic on the face, but we are very focused on the therapy on the disease area, because we want to leverage where we are strong and where we know where we have a very strong corporate knowledge about the disease. So that's what is guiding us for our business development strategy. Thank you very much.
Speaker 1: transcript
Speaker 1: Okay, thank you very much. Okay, since we are getting close to the end of the call, the next question will be our final question. So I'd like to call upon Ueda-san from Goldman Sachs.
Okay. Thank you very much okay. Since we are getting close to the end of the call. The next question will be our final question. So I'd like to call upon where the Sun from Goldman Sachs with them on a guy Cmos.
Speaker 7: transcript
Speaker 7: I'm Ueda from the Asakusa Prefecture. Thank you very much. I'd like to ask you two questions about business development. The first one is what you've shown on the 19th page. Regarding oncology, there's been a negative progression in X-activity, and there's been a lot of cooperation with Alunbringbo, so I think the growth of new products is a bit of a tough situation. I'd like you to tell us if there's anything we can do to help.
What are the most likely still getting away that they will die muscle don't want to go through what they muscle.
She got Arnold Yo Kai hustling.
And we'll go lifestyle schedule more megawatts.
Make a note one I'll jus Cupid two there was some issue W. David talk all day on the oncology and you'd see this next <unk> and they've got to relax in chocolate for Nicaragua, I'm going to walk through all of the Huggies snug.
North H O fish and thinking through it can.
<unk> got up on way musket at the local one then you got to equate and there's still a lot of talk on like although I'll tell you that the order will ship either luckily about the way muscle.
Speaker 16: transcript
Speaker 16: Kind of Stu little condition. Y pippea, you comment to UC more, but again you do it franchis. But do it know sayhase this H say: no indic ions you to age like a must, that asscle.
That's a mouthful if a condensed it isn't it won't be on the pipe right now.
Mental model you must look at it more like Angel Deutsche suffered unsafe.
On the wall faces another nickel quite Hudson's faith in all other all in nice afternoon memorial kind of like to even look at though you wouldn't see it they get hung up on those ships that came off the initial muscle.
Speaker 1: transcript
Speaker 1: Thank you, Eda Sand for that question. So a question around our business development plans. First of all, in oncology to supplement the portfolio and then looking at the pipeline, which phases which therapeutic areas had like class Christoth to comment on.
Thank you <unk> for that question. So a question around business development plans.
A all in oncology to supplement the portfolio and then looking at the pipeline, which phases, which therapeutic areas I'd like to ask Christophe to comment on this.
Speaker 2: transcript
Speaker 2: Thank you, Wienia-san, for the question. So first, I would say that we are not looking, we just reconfirmed to everyone that we are not looking at large M&A for scale purpose. We are very competitive in all the key countries where we operate. So we don't have a scale or a competitive issue in that regard. So it's all about portfolio pipeline, so targeted BD.
Thank you Shannon for the question. So first of all I will say that we're not looking we're just reconfirmed to everyone that we're not looking at the <unk>.
Large M&A for scale purpose, who we are we are very competitive in all the key countries, where we operate so we don't have our scale or a competitive issue in that trade yard. So it's all about portfolio pipelines for targeted BD.
Speaker 2: transcript
Speaker 2: On oncology, if we can bring new assets like Fris-Acla, Fricitinib that we just licensed, that would be terrific. So we are looking at this type of this to complement our portfolio. We have a very attractive pipeline but it's more mid-stage so many of these products in our pipeline will be launched towards the end of the decade. So if we can bring more assets to enrich our portfolio will do and
On the oncology, if we can bring in new assets like <unk> Africa generators, we're judging license that that would be a terrific. So we are looking at these type of deals to complement our portfolio. We have a very attractive pipeline with its mortgage stage. So many of these products in our pipeline.
It will be launched towards the end of the decade. So if we can bring more effects to enrich our portfolio will do and.
Speaker 2: transcript
Speaker 2: We follow in fact, roughly the same approach across the therapy area.
We follow in factor roughly the same approach of <unk> across a therapy area. Obviously, we are a leader in the GI space. So if we can bring those are assets will do.
Speaker 2: transcript
Speaker 2: Obviously, we are a leader in the GI space. So if we can bring other assets, we'll do. We shouldn't forget that we have a very strong position in rare disease, in LSD disease. So we are looking at that. In plasma derived therapy, there is not much to do. So it's really about making our portfolio and pipeline more competitive.
We shouldn't forget that we have a very strong position in rare disease.
In <unk> disease. So we are looking at that.
Investment derived therapies, there is not much to to do so it's really about making your portfolio and pipeline more competitive. So I think you know.
Speaker 2: transcript
Speaker 2: So I think we are quite agnostic on the face, but we are very focused on the therapy, on the disease area, because we want to leverage where we are strong and where we know, when we have a very strong corporate knowledge about the disease. So that's what is guiding us for our business.
We are quite agnostic on their phase, but we are very focused on the therapy.
Because we want to leverage our where we are strong and where we know when where we have a very strong core quite knowledgeable about the disease. So that's what is guiding us for our business development strategy.
Speaker 16: transcript
Speaker 16: Thank you very much.
Somebody that's all what I must say you know muscle.
They got those I must stop.
Speaker 1: transcript
Speaker 1: I thank you for your great cocktails for this fight. See you next time!
I'm not clear on what you must stay home. It's nowhere then our studio assassinate the vacuum much.
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Okay.