Sumitomo Pharma Co., Ltd. (4506) Earnings Call Transcript & Summary

[Interpreted] This is Sumitomo Dainippon Pharma. Now it's time to start the Sumitovant meeting. Thank you also very much to participate in today's meeting despite your busy schedule. In order to cope with the COVID-19, we are going to bring the live streaming where you can choose either Japanese or English or the telephone conference line, which will be distributed in Japanese from the Tokyo head office today. In closing, there are 2 points that I would like you to bear in mind. There is a time discrepancy between the telephone line and live streaming. So for those who are going to make a statement or ask questions, we strongly advise you to use the voice communication on the telephone line. And we only accept the Japanese questions as was already announced. And this live streaming will be recorded. And I also like to ask you to answer to your questionnaire for the reference for the future IR activities. Now I would like to introduce today's attendees: Mr. Nomura, President and CEO; Mr. Kimura, Senior Executive Officer, Chief Scientific Officer; Mr. Baba, Senior Executive Officer, in charge of Data Design; Mr. [ Tochiya ], the Head of the Data Design Office; and from Sumitovant, CEO, Myrtle Potter; Chief Information Officer, Dan Rothman; Chief Algorithmic Analytics Officer, Bill McMahon; Chief Medical Officer, Sam Azoulay; Chief Business and Commercial Development Officer, Adele Gulfo; Executive Vice President, Haruyama; and I'm the moderator from communications, my name is [ Harada ]. And the presentation will be given by Mr. Nomura, Myrtle, Dan, Bill, Kimura. And Q&A will be also addressed from the -- by Baba, [ Tochiya ], Sam and Adele and Haruyama. Thank you. First, I would like to start the introduction of Mr. Nomura first, so Mr. Nomura, the floor is yours.

[Interpreted] Good morning, everyone. This is Nomura speaking. Thank you very much for your interest in our management, in our daily business. And I also like to thank you for participant this Sumitovant meeting today. As for the relationship with Sumitovant, we had closed the strategic alliance with the Roivant in 2019 and had an opportunity to explain in detail and followed by some more explanation about the strategic alliance. But we have not yet had the opportunity to explain the progress of our business strategy comfort, so I hope that you will be able to deepen your understanding about the business alliance. I think Page 4 is showing now. This slide shows the strategic alliance with the Roivant, and we used this same screen when I explained. And I repeatedly said that we are looking at the best-in-class, focused on value. And we are not able to conduct the clinical study of napabucasin for pancreatic cancer. And how we are going to draw these growth strategies for the future, that was the key, so in the strategic alliance with Roivant, relugolix and vibegron, which are positioned in the late-stage development pipeline, and that is why we decided to actually make this a business strategy. So that is why this best-in-class, focused on value, was highlighted. And other than that, we had many other areas to focus, cell therapy and the other candidates, for the modifiers for gene and other candidates. There are many researches or pipeline that was not really focused at the time that we made the strategic alliance with Roivant back then. And on Page 5, capturing the pipeline is one thing, and another important point is the digital transformation. Even before the strategic alliance with Roivant, we declared that we're going to focus on the digital information in our midterm business plan. But with the strategic alliance with Roivant, we are now able to capture the DrugOme and Digital Innovation platform as well as the excellent talents were captured. So we had a huge jump to increase the level of the digital transformation. The one year, last year, we had spent our time trying how to use these new DrugOme and DI platform. But from this year onward, we would like to squarely tackle with the actual utilization of this new -- the platforms and so forth. And this will be further explained later as for our digital transformation. So that is basically the purpose of today's meeting. So we believe that the major players of today's meetings are the people from the Sumitovant, and I would like to ask each and every person from Sumitovant to give the explanation. The first one is Ms. Myrtle Potter regarding the portfolio of the Sumitovant.

[Interpreted] Thank you very much, Mr. Nomura. So for -- next, I would like to introduce Ms. Myrtle Potter to explain the Sumitovant Biopharma's portfolio overview. Ms. Myrtle, the floor is yours.

Thank you. Thank you very much. At Sumitovant, our focus is on accelerating the identification, development and commercialization of the important new therapies that have the potential to improve patient care and outcomes. Since our inception in December 2019, our aim has been to rapidly deliver innovative medicines by leveraging our unparalleled technology-enabled approach to drug discovery, development and commercialization. Sumitovant has cultivated a diverse pipeline of modalities and therapies that have a singular focus, and that is addressing conditions with significant unmet patient need. Our technology-enabled approach allows us to accelerate and derisk every aspect of the clinical development and commercial process through this approach, and with patient outcomes at the forefront of our focus, we aspire to change lives for the better. Biotechnology modalities have increasingly become a more significant contributor to top-selling global therapies over the past 5 years. In 2015, biotech modalities made up about half of the top-50 selling therapies globally, but have grown to almost 60% of top-selling therapies in 2020. Biotech modalities also generated more revenue on average per asset, underscoring their greater revenue potential versus conventional modalities such as small molecules. Biotech modalities' contribution to total revenue growth across all global therapies is also expected to increase over the next few years. So again, this is a signal that these modalities will continue to be a driver of global pharmaceutical revenue in the future. At Sumitovant, we take a diverse approach to investing in molecules with unique biotech modalities, representing 67% of our pipeline molecules. Sumitovant recognizes the potential of biotech modalities to become top-selling therapies, and we've designed our portfolio to leverage this potential. This diversified portfolio approach, paired with our DrugOme technology and our Digital Innovation platform, enables us to rapidly build and advance a diverse portfolio of transformative therapies across many indications. We've made significant progress in advancing our pipeline of assets. Notably, we recently received FDA approval for relugolix, brand name ORGOVYX, for the treatment of advanced prostate cancer; and vibegron, brand name GEMTESA, for the treatment of overactive bladder. And we expect several milestone achievements across our pipeline in the coming year. ORGOVYX is Sumitovant's first FDA-approved therapy. It is the first and only oral GnRH receptor antagonist for the treatment of advanced prostate cancer. As a GnRH antagonist, ORGOVYX blocks the gonadotropin-releasing hormone receptor and reduces the production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer. First-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, or ADT, which reduces testosterone to very low levels, commonly referred to as castrate levels. The current standard of care for patients seeking ADT are GnRH agonists, such as leuprolide acetate that are delivered as depot injections. However, these therapies may be associated with mechanism of action limitations, including a potentially detrimental initial surge in testosterone levels that can worsen clinical symptoms and delay testosterone recovery following treatment discontinuation. ORGOVYX offers men with advanced prostate cancer a new oral treatment option that demonstrated a differentiated clinical profile with a convenient one-pill once-a-day regimen. In the Phase III HERO study results that were published in the New England Journal of Medicine in June of 2020, ORGOVYX demonstrated a favorable efficacy profile across a number of key end points. ORGOVYX achieved a high PSA response rate in the majority of men at day 15 compared to leuprolide. ORGOVYX also achieved a rapid, sustained suppression of testosterone, with no initial hormonal flare. Patients treated with ORGOVYX maintained testosterone at castrate levels throughout the treatment period. In contrast, an initial surge in testosterone levels from baseline was seen in the leuprolide treatment group before decreasing to castrate levels at day 29 and remaining at castrate levels thereafter. In a subgroup of 184 patients followed after treatment discontinuation, a high percentage of patients treated with ORGOVYX experienced testosterone recovery within the normal range of 90 days after treatment discontinuation compared to patients treated with leuprolide. The Phase III HERO study results published in the New England Journal of Medicine also demonstrated ORGOVYX' favorable safety profile. Overall, ORGOVYX was generally well-tolerated, with an adverse event profile similar to that of leuprolide. Please note, other important information, including the complete safety information, can be found in the full prescribing information on the ORGOVYX website. The Phase III HERO study results also demonstrated ORGOVYX' favorable safety profile in terms of the incidence of major adverse cardiovascular events or MACE. Kaplan-Meier estimates showed that patients treated with ORGOVYX had a lower risk of MACE compared to that of leuprolide. This is an important clinical differentiator as an estimated 30% of prostate cancer patients have diagnosed cardiovascular disease and more men with prostate cancer die from cardiovascular disease than from prostate cancer itself. With its differentiated clinical profile, coupled with its patient-preferred oral formulation, we believe ORGOVYX is poised to become the new ADT standard of care. Myovant launched ORGOVYX in the U.S. in January of 2021 and is actively executing on 3 key launch priorities: the first is educating physicians so that they are confident prescribing ORGOVYX; the second is establishing broad access by enabling seamless treatment starts; and third, engaging patients to drive awareness and seek treatment. Myovant's 100 sales representatives have been actively promoting ORGOVYX to prescribers and have already received tremendous prescriber interest and feedback. In addition, we believe the collaboration with Pfizer can potentially accelerate uptake and maximize the commercial potential of ORGOVYX by leveraging Pfizer's high-quality neuro-oncology sales force, its commercial infrastructure as well as its expertise. Pfizer has historically demonstrated success in the prostate cancer market through its promotion of XTANDI, which experienced double-digit growth in 2020 despite the COVID-19 epidemic. Due to the large percentage of in-office dispensing and specialty pharmacy distribution dynamics, we believe that achieving broad ORGOVYX adoption goes beyond clinical education to encompass office economics and operational considerations. Myovant's 100-person sales force and Pfizer's 100-person uro-oncology sales team are equipped with materials and technology to interact with prescribers virtually as well as in person. Over just 5 weeks after launch, Myovant's sales force alone had 10,000 interactions with health care professionals, including interactions with academic centers, large oncology and -- urology and oncology group practices that drive a significant share of ADT prescriptions. The economic component primarily impacts those practices with in-office dispensing capabilities. The vast majority of these practices now have access to our ORGOVYX contract pricing. And the majority have already ordered at least once, and many of them have already reordered. Operationally, a seamless prescribing process is important for ORGOVYX adoption. Within the first 5 weeks of launch, half of our highest-priority accounts have ORGOVYX in their e-prescribing system, another leading indicator of continued ORGOVYX adoption. On Slide 14, we see here that we've also made notable progress in establishing broad patient access for ORGOVYX. Approximately 30% of commercial patients had access to reimbursement in just 5 weeks after launch, through prereview coverage. Initial commercial coverage decisions are expected in the first half of 2021, which should support coverage for most commercial patients beginning in the second half of 2021. For Medicare Part D coverage, we expect some Medicare Part D plans to offer access to ORGOVYX in 2021, with broad coverage anticipated no later than January of 2022. In addition to broadening awareness and driving patient adherence, Myovant is off to a strong start regarding patient engagement. Within the first 5 weeks of launch, we had over 37,000 total visits to the ORGOVYX patient website, with nearly 1 in 5 unique visitors downloading material. This is 4x higher than our benchmarking data for other recent oncology product launches. Relugolix combination tablet or relugolix CT, which consists of 40 milligrams of relugolix, plus 1 milligram of estradiol and 0.5 milligram of norethindrone acetate, is a once-daily oral pill being studied in uterine fibroids and endometriosis. If approved by the FDA, we believe relugolix CT has the potential to transform multiple hormone-driven diseases in women's health. Uterine fibroids and endometriosis are indications with high unmet medical need and can cause debilitating symptoms like heavy menstrual bleeding and severe pain. 5 million women in the U.S. suffer from symptoms of uterine fibroids, and an estimated 3 million women are inadequately treated by their first medical therapy. An estimated 6 million women suffer from symptomatic endometriosis in the U.S., and 1 million women have failed their first therapy. A new drug application, NDA, for relugolix CT in uterine fibroids has been accepted by the FDA, and it has designated a PDUFA action date of June 1, 2021. We also recently announced the publication of the Phase III LIBERTY program in the New England Journal of Medicine. We've generated positive Phase III data for relugolix CT in endometriosis, and we are on track to file our regulatory submission to the FDA in the first half of 2021. Similar to ORGOVYX, Myovant and Pfizer will co-promote relugolix CT in both indications. In this area, we believe patient education and activation will be particularly important, so our efforts will benefit from Pfizer's expertise in direct-to-consumer outreach. At 52 weeks, both the efficacy and safety data for relugolix CT were consistent with prior data, demonstrating a clinically meaningful reduction in menstrual blood loss, while maintaining bone health. In the LIBERTY extension study, 87.7% of women treated with once-daily relugolix CT met the responder criteria and demonstrated sustained improvement in heavy menstrual bleeding through 52 weeks. Additionally, women experienced on average an 89.9% reduction in menstrual blood loss from baseline at 1 year. From a safety standpoint, the incidence of adverse events over 1 year was consistent with that observed in LIBERTY 1 and LIBERTY 2, with no new safety signals observed. Changes in lumbar spine bone mineral density were also maintained over a 1 year treatment period. Bone mineral density loss is a potential risk with other current treatment options, emphasizing relugolix CT's unique clinical profile. Relugolix CT's long-term efficacy and safety profiles were also confirmed in the SPIRIT program. In the SPIRIT extension study, 85% and 73% of women, respectively, reported clinically meaningful reductions in dysmenorrhea and nonmenstrual pelvic pain at 1 year. Importantly, bone mineral density loss, which was minimal and not clinically meaningful after 24 weeks, stabilized from week 24 to week 52. Now let's consider these results in comparison to the results from the 52-week extension study or another once-daily GnRH antagonist, which are displayed on the right side of the table. Again, it's important to mention that while these studies have similar designs, comparing data from different studies must always be done with caution. Results after 1 year of treatment suggests that relugolix combination therapy has the efficacy profile compared to or slightly better than that of the high dose of the other GnRH antagonist, with a safety and tolerability profile that is comparable to or slightly better than that of the low dose of the other GnRH antagonist. Given the data from both the LIBERTY and SPIRIT programs, we believe relugolix CT, if approved, has the potential to become a best-in-class option for women suffering from uterine fibroids and endometriosis. GEMTESA received FDA approval in December 2020 for the treatment of overactive bladder, OAB, with symptoms of urge incontinence, urgency and urinary frequency in adults. Approximately 1 in 10 Americans are impacted by bothersome OAB symptoms that can have a major impact on daily life. GEMTESA is the first oral branded OAB medication approved by the FDA since 2012. It's a selective human beta-3 adrenergic receptor agonist and is formulated as a convenient once-daily 75-milligram tablet. We believe GEMTESA's FDA-approved label is favorable for best-in-class differentiation. GEMTESA has a single crushable dose and requires no dose titration. Patients receive the fully effective starting dose of 75 milligrams. The GEMTESA label includes data specifically showing reduction in the urgency episodes, which is a hallmark symptom of the condition, which is unique amongst currently available OAB treatments. Finally, GEMTESA's label carries no warnings related to increased blood pressure or CYP2D6 interaction. Please note, other information, including complete safety information, can be found in the full prescribing information on the GEMTESA website. The Phase III EMPOWUR study demonstrated GEMTESA's favorable clinical profile in both efficacy and safety. As it relates to efficacy, on average, GEMTESA demonstrated a greater reduction from baseline in average daily number of urge urinary incontinence episodes versus placebo. GEMTESA also successfully achieved its other primary end point by demonstrating statistically significant reduction in daily micturitions compared to placebo. Please note, while Tolterodine, the currently available OAB treatment, was studied in the EMPOWUR study as an active control arm, it was present to confirm sensitivity and therefore not included in the GEMTESA prescriber information label. As it relates to safety, on safety among adverse events of interest, GEMTESA demonstrated rates of hypertension, increased blood pressure, urinary tract infection and urinary retention similar to placebo and lower than Tolterodine. For a complete listing of the important safety information, please reference the full prescribing information that can be found on the GEMTESA website. In addition to the data shown on this slide, GEMTESA also met all 7 key secondary end points, including a clinically meaningful reduction in daily urgency episodes versus placebo and Tolterodine. Urovant will launch GEMTESA in the U.S. market in April 2021. In preparation for this launch, Urovant aims to establish GEMTESA as the best-in-class category treatment for patients suffering from symptoms of OAB, including urge urinary incontinence, urgency and urinary frequency. To accomplish this, Urovant will execute against 5 key launch objectives that will form the foundation for GEMTESA's commercial success in OAB. First, we will anchor launch performance through a focus in urology. Second, we will establish leadership for OAB in the long-term care setting. Third, we will broaden uptake in primary care for OAB patients. Fourth, we'll secure and maintain access and affordability for patients and HCPs. And lastly, we'll drive awareness, education and advocacy for OAB patients. To support a successful launch in the OAB market, Urovant is focused on the execution of key commercial priorities. 160 Urovant sales representatives will detail prescribers in the urology long-term care and high-prescribing primary care segment. These segments account for greater than 50% of all OAB prescriptions, with urologists prescribing 30% of all beta-3 agonists. Urovant will significantly expand its commercial footprint of vibegron through a co-promotion agreement with Sunovion to co-promote GEMTESA in the broader primary care segment. Sunovion will deploy 90 sales representatives to bring vibegron to primary care physicians. Urovant's market access team is proactively engaging with pagers -- payers to support rapid and broad access to GEMTESA as quickly as possible after launch. Finally, Urovant is activating patients through a multichannel marketing campaign, including through the use of digital and social media. We're excited for the launch of GEMTESA in the U.S., and we believe it will provide a compelling alternative for the tens of millions of patients living with the burden of OAB. Now moving to rodatristat. Rodatristat ethyl is a small molecule, tryptophan hydroxylase, TPH inhibitor, being studied in a Phase IIb clinical trial for the treatment of pulmonary arterial hypertension. Rodatristat, delivered as an orally bioavailable prodrug, is designed to selectively reduce peripheral serotonin production by inhibiting TPH1, which is an enzyme responsible for the conversion of tryptophan to serotonin. TPH1 has been shown to be upregulated in PAH patients, causing an increase in locally produced and platelet-derived serotonin. This excess serotonin stimulates the thickening and constriction of pulmonary blood vessels by acting through serotonin receptors and transporters, leading to pulmonary arterial hypertension. Rodatristat ethyl's molecular structure was designed to prevent it from crossing the blood-brain barrier, therefore restricting its effect to peripheral serotonin. In animal models, rodatristat alone and in combination with ambrisentan, an existing PAH treatment, showed robust reduction in vessel wall thickness. In an additional study, dose-dependent urinary 5-HIAA suppression, the main serotonin metabolite, was shown to support a 300- to 600-milligram twice-daily Phase IIb study dose. This was shown to provide a 50% or greater reduction in 5-HIAA, which was the initial targeted reduction level. We're continuing to study rodatristat for the treatment of pulmonary arterial hypertension in a recently initiated international Phase IIb dose-finding trial. The primary end point for this study is the change from baseline at week 24 of pulmonary vascular resistance as measured by right heart catheterization. The first patient for this study has already been initiated, and the top line data readout is anticipated in 2023. Across our 5 vants, there are tremendous opportunities for growth driven by an innovative portfolio of diverse molecules targeting indications with significant unmet patient need. We're excited about the commercial success of ORGOVYX and GEMTESA, and we look forward to sharing additional regulatory updates from our pipeline programs throughout the year. Thank you.

[Interpreted] Thank you very much, Ms. Myrtle. Next, I would like to introduce Mr. Dan Rothman to explain about the digital transformation. Dan-san, the floor is yours. Thank you.

Thank you. Over the next 15 minutes, I will give you an overview of our digital transformation, how we are driving technological and behavioral change. We will look at a number of examples of actual solutions that we've deployed across the DSP Group. But first, what is digital transformation? At its heart, digital transformation is behavioral change. Our goal is not just to change the way we apply technology. It is not just to make us able to develop our own technology in-house. It is not just to better leverage external technology providers. These are all necessary ingredients of digital transformation, and we do focus on them, but they are not sufficient by themselves. The goal of digital transformation is to change behavior, to leverage these improvements in our adoption of technology in order to change the way that we do business, to make our businesses more nimble and more efficient, more transparent and better at communicating information internally, better at leveraging data in our decision-making process, more focused on maximizing delivered value to patients and to shareholders and as a result, to bring more drugs to market more rapidly and get them to the patients that need them. So how do we accomplish all of that? First, we deployed the new teams that we acquired in the deal with Roivant 15 months ago, DrugOme and Digital Innovation. DrugOme is a centralized data science team that develops a computational ecosystem to enable fast, high-quality answers to pharma questions. This ecosystem consists of data, code, data scientists, but also specialized expertise on the data sources that matter most for our strategic pharma decision-making. Bill McMahon, our Chief Analytics Officer, will tell you more about DrugOme shortly. Digital Innovation is a federated team of technologies. They're data scientists, engineers, mathematicians. They embed directly in our business teams. And by doing that, they become an integrated part of those teams. They can all program. They can all write code. But first and foremost, they are business problem-solvers. Because they're embedded in the business teams, they build greater connectivity, which creates stronger trust and a deeper understanding of the business' needs and issues. That enables them to rapidly identify where new technology solutions can deliver the most value, whether that means quickly creating a new ad-hoc data analysis to solve a specific problem or building sophisticated tools that combine artificial intelligence solutions with improved workflow automation. Digital innovators continuously iterate and improve the technology with their business team to optimize its effectiveness. But Digital Innovation is also a coordinated team, so they share the solutions they build with each other. That enables us to leverage the work they do across the whole group of companies and maximize the value created. Next, after introducing the new teams, we built connectivity between the many technology teams that already existed across the DSP Group, connecting these existing teams with each other, so they can share knowledge, capabilities and best practices, so they can identify opportunities to reuse implementations, and so they can create better opportunities for collaboration, cooperation, discussion and idea generation. Finally, we provided a clear set of digital transformation objectives for all of these technology teams. So here, on Page 37, are the DSP Group digital transformation objectives. They are grouped in 2 themes: enhance our core businesses; and increase value delivery in execution. In each theme, there are 3 objectives. Each of our technology team identifies their own objectives and maps them to these higher-level objectives. In this way, the objectives provide a common set of goals. They align our digital vision across the DSP Group. So now let's look at some of the results. We're going to look at real examples of technology that we've built to accomplish these objectives. The examples you'll see are all real tools that we use. However, the data is not. So the information you will see in the demos is just for demo purposes. It does not reflect any actual information about any of the DSP Group companies. Here, on Page 39, is an example of the first objective, increase revenues across the commercial portfolio. This is a tool that uses data analytics to better identify KOLs. We use a variety of different sources, including publications, claims data as well as social media feeds to identify those doctors who would make the best KOLs, those doctors who have the greatest influence on other doctors. As you can see on the screen, our commercial teams can choose how to weight different characteristics from the various data sources. And as they do so, they immediately get new lists of potential KOLs optimized for that weighting. They can then look at the maps to see the regional distribution of the KOLs they've identified. This enables the humans to partner with the computers, the salespeople to work with the data analytics, to find the optimal set of KOL candidates. And as our salespeople contact these KOLs, they can continue to modify the inputs themselves to improve the results. They also provide feedback to the digital innovator and their team to improve the underlying data science models. Moving to the second objective, bring more drugs to market more rapidly. This example is used in preclinical. Our scientists are spending hours and hours of time watching videos to find specific mouse behaviors that take only seconds. So we felt we could make that more efficient. We use machine learning to train a computer to watch the hours of video for them. It then highlights the seconds of footage where the specific behavior occurs. Now the scientists, instead of watching hours and hours of video, they click a button, they go directly to those few seconds in the video where the behavior occurs, and they can confirm what the computer identified. It's taking weeks of tedious work and turns it into minutes. We complete the analysis of the results much more quickly, but also, our people can focus on work that is much more rewarding. The third objective, increase the success of drug discovery programs. In the next example, on pages 47 to 49, we increased the throughput of our drug discovery efforts. In this way, we efficiently focus on fewer drug candidates, but drug candidates with a higher probability of success. Our researchers used to spend significant amounts of time reading research. But many of the articles they would read were irrelevant. They were a waste of their time. But they had to read them to figure it out, to identify that they were not worth reading. They would go through a myriad articles just to find a few that might have a new protein in them that's worth investigating. So now natural language processing tools preread the articles for them. And machine learning models score them to identify the ones that are useful. They can focus on a smaller set of articles that have a higher probability of being relevant and valuable. But it doesn't stop there. Once they identify an interesting candidate in the research, we can immediately examine the potential of the identified protein directly in the same tool. As you can see here, they have detailed information immediately at their fingertips. And it's shown in a way that can be easily visualized and assessed. So they can form their own opinions and identify what candidates to pursue. But there's still one more step. The dials you see on Page 49 are the scores that the machine learning model assessed for the given protein. After our scientists form their own opinion, they update these scores. And the model learns, the model uses that information to improve its assessment of other research in the future. In some way, as you've seen from these examples, all of our digital solutions achieved this objective; improved business operations and processes. So I thought for this one, I would share a way in which we not only leverage technology, but we also leverage our operational approach to drive transformation. Our technology teams use an agile approach to efficiently deliver effective technology solutions. Here's an example on Page 53 of a Kanban board that we use to manage our team's tasks. But we knew this worked for our technology teams. We felt we could make it work for teams outside of technology. So we worked with teams outside of technology to apply these same agile approaches to their business so that they too could be more efficient and more effective. We now have many agile teams outside of technology. We have teams in legal, intellectual property, corporate communications, medical information, health care experience, CMC. These teams have increased their throughput, and they found ways to be more proactive. They also reflected that by using these tools and using an agile approach, they felt more connected as a team, which is especially important when they're all working remotely due to COVID. Transparency and collaboration are key to any organization. They enable better sharing of information and more fluid communication, better decision making. We use technology to facilitate that sharing, while at the same time, assuring that the appropriate data security controls are in place. Now as we look at this example on Page 57, I want to remind you that while the tool you're seeing is the actual tool that the team uses, the data that you were seeing is all fake. So this example shows a tool that tracks the progress of all of the development teams across all of Sumitovant subsidiaries. It's used by the Sumitovant's CMO and his team. With this tool, they can make sure that they always have a consistent source of information that is timely, easily accessible and most importantly, accurate. By having this detailed level of transparency in every trial, the team can take rapid actions on any issues, and they can continuously make well-informed decisions to reduce trial times. So I'm not going to show you an example for this last objective because it's actually evidenced in all of the examples you've seen today. Technology teams partner with the business to create value. This is our underlying approach. We empower our technology teams to be equal partners with the other business teams with whom they work. And through this partnership, we combine the business knowledge and the technology knowledge. We bring them together. And as you've seen in these examples I shared, this enables them to efficiently identify the best ways to deploy technology to deliver business value. I hope you have a better understanding now of the digital transformation that we are in the process of driving across the DSP group. And through the examples, a better understanding of the actual ways in which that transformation is creating substantive value. But this is only the first year. It's just the beginning. We will continue to build on this progress and scale these capabilities in 2021 and beyond. Innovation today and innovation tomorrow leads to even healthier tomorrows. Thank you.

[Interpreted] Thank you very much, Dan. Next, I'd like to introduce Mr. Bill McMahon to talk about the DrugOme. Bill-san, please come to the microphone.

Thank you. Today, I'll be talking to you about the DrugOme, a unique tool set and approach to pharma strategy that we have been developing in Sumitovant. I'm sure your first question is, what is the DrugOme? From the highest level, the DrugOme is a computational ecosystem to enable fast, high-quality answers to strategic pharma questions. Many of these strategic questions arise when conducting due diligence to determine whether to in-license a new potential drug or therapy, and under what development strategy that drug or therapy optimizes the path to satisfying the most unmet need, maximizing the potential value of the drug. The initial development efforts on the DrugOme arose out of an effort to rationalize the data analysis used for due diligence on potential in-licensing targets, that is, trying to understand what makes a drug valuable. More recently, we have been applying our tools and expanding our tool set, both within Sumitovant and broadly across the DSP family of companies, from the drug discovery phase through commercialization. The tool set we have can be applied to all stages of drug development because the question of what strategy to use to ensure a drug maximizes its potential is relevant at every stage. So what do we mean by an ecosystem? The DrugOme consists of the data sources, the computational infrastructure, the code and the analytics capabilities and the domain expertise to rapidly synthesize analyses about ad-hoc pharma questions. On top of that core of expertise, we have 3 teams created to adapt to 3 technology-guided focus areas: artificial intelligence for knowledge discovery; drug development intelligence; and real-world data and evidence. We call these focus areas the pillars of the DrugOme. The development of the pillar capabilities arose as a response to 3 technology trends that are changing the face of curation in a drug development context. First, the improvement of artificial intelligence techniques; second is the availability of structured competitive intelligence data; and third is the increasing capture of medical transactions and available the identified electronic claims. These pillars support capabilities across a broad range of use cases from drug discovery to commercialization. A small fraction of the capabilities that arise out of these areas of focus are highlighted in these 3 pillars. The DrugOme team applies these capabilities in a case-specific context. We have developed a library of computer code that encapsulates an abundance of simple analyses. In some cases, we may embed versions of these analyses in web apps to support broader access to those simple analyses. In the more common cases, we incorporate simpler analysis into a more sophisticated analysis that represents a more holistic view of strategic situations. We can do this because we have codified these simpler analyses in our library of DrugOme computational code. Some examples of the simpler types of analyses that we did in past business development activities include: first, using claims to test hypotheses about potential drug value given different possible clinical development pathways; second, generating metrics for clinical competitive intensity; third, using natural language processing on top of the scientific literature to explore drug target relationships. An updated version of such a business development analysis would incorporate all of these into an aggregate metric for every drug in clinical development with a given mechanism of action, enabling a holistic ranking of value for such a drug based on the different clinical development pathways. But our scope has expanded beyond business development in a variety of ways over the past year. On the real-world data side, we have expanded towards the post-approval process. We have worked closely with various health economics outcome research teams and translated our claims expertise into scientific publications. We have also incorporated our more typical epidemiological analyses into a variety of contexts, including clinical strategy, commercial forecasting, commercial strategy, key opinion leader analyses and prescriber deciling. The artificial intelligence pillar of the DrugOme has expanded to the preclinical stage of the drug development process. Drug discovery involves a high-level view of the scientific landscape of diseases and their mechanisms. Natural language processing enables the creation of structured data out of large bodies of text, in particular, the scientific literature. Structured data enables us to work with the drug discovery team within Sumitomo Dainippon Pharma Oncology and create quantitative metrics for many of the components of their methodology for selecting genes as potential oncology targets. We believe this will lead to the selection of higher quality targets with a higher level of scientific validation. Ultimately, it is the quality of the target that determines the likelihood of clinical success and success in clinical trials is the most important determinant of drug development costs. We also continue to expand and refine our traditional DrugOme approach using structured data and natural language processing to assist in the process of curation to improve the ability of Sumitovant on business development activities. Over the course of the past year, we have delivered business development analyses across various of the Dainippon Sumitomo family of companies. A general observation that I've heard with regard to artificial intelligence approaches within pharma is that they are being applied to the parts of the pharma value chain that are not fundamentally the highest cost areas. As a result, even if they are effective, they will have a low return on investment. We are taking a different approach. We are applying those artificial intelligence approaches, combined with the best available data to understand the highest return on investment areas in the pharma value chain. We then focus our efforts in developing techniques to leverage data and algorithms better at those highest return parts of the pharma value chain. The ultimate representation of that is developing a consistent view of the value of an overall portfolio of diverse drug assets. We have been developing the tool set to enable a coherent approach to that most difficult of tasks. We are continuing to develop all of the technologies we have discussed. And together with the Digital Innovation team, clinical development, finance, commercial teams within Sumitovant, we are working to integrate the set of internal and external data into a combined clinical development and commercial forecast, incorporating all of our most advanced techniques. This approach will ensure that the new technologies of analysis being developed are fundamentally aligned with the highest return on investment activities. This portfolio picture will be used to guide strategic activity and investment within Sumitovant. Thank You.

[Interpreted] Bill-san, thank you very much. Next, I would like to introduce Mr. Kimura to talk about expectations for Sumitovant and synergies in R&D. Mr. Kimura, please. Thank you very much. Yes, please.

[Interpreted] I'm sure that you have understood sufficiently, as you listen to the other presentations. But it is written at the bottom, the best-in-class focus on value is our mission, and that's how we're going to support our revenues. As was previously explained, actually, the global specialized player is the aim that we have using the pharmaceuticals and solutions. And also, we want to be the global leader in 3 areas. And I think you understood that our approach. Last but not least, I'd like to talk a little bit about the Sumitovant and DSP and its synergies in R&D. First, let me give you the current status in each therapeutic areas as well as our issues. So let me first look back the fiscal year 2020. As for Sumitovant, the development of relugolix and vibegron had been successful, as was explained. And also related products of relugolix and vibegron are expected to grow. And as for RVT-802, we have received the complete response letter in 2019, but we hope that we'll be able to resubmit the file soon. On the other hand, the psychiatry and the neurological area, following the LATUDA, SEP-363856 and SEP-4199, the candidates in late-stage development pipeline are now in progress. And this pipeline is not continuing, and that, I'm afraid, is the -- a big problem. But after July this year, we create 7 new development candidate compounds. So for the future, we will be able to expand multiple numbers of these 7 new development candidates to be a blockbuster. And also the napabucasin was not able to reach the endpoint -- primary endpoint. And the Parkinson's disease and retinitis pigmentosa, the research area, and RVT-802 is likely to submit the NDA. And as for the new area, which is the Frontier business, we are tackling with various issues. So we would like to actively use the Sumitovant model for further advance of each pipeline. This is the product launch target within a few years. The thick green line boxes are the Sumitovant's derived products and already the -- ORGOVYX has been launched and multiple number of products are to be launched in near future. So these products, in coming 10 years, will become the pillar of our revenue. And as you know, on the top, the existing products, LATUDA, in the beginning of the 2023 will have the LOE. And I'm sure that you're all worried about it. But I would like to use the Sumitovant to support our business. 856 and oncology and regenerative products business will be reconstructed or to establish. So there are 7 development candidates in pipeline, I've already mentioned. So these are in the clinical development line, will be supporting our revenue in the future. So in the coming 10 years, Sumitovant products will be the main source of revenue, including R&D expense. On the other hand, regarding the clinical development, this is the geographical model. And the green spot shows the DSP group current development bases in Japan and also the Asia, China. And in the U.S., New Jersey and Massachusetts. And Sumitovant is a unique feature. In each area, we -- there are development bases. And in total, we have so many the -- development bases. And that was not only for the geographical distribution. But let me show you one example. It's -- this is the Enzyvant. And the number of employees only 20 or 30, and the key people are distributed throughout the world. With the COVID-19, we are doing the remote work for the past 1 year. And exactly this is the model that you don't have to be at a specific location. You can have appropriate people for -- to promote the smooth development. And this is the pipeline of the Sumitovant. And as mentioned earlier, relugolix and vibegron, these are the small molecules. But 2/3 are the biotech modality. So what we call the new modality product, the proteins and gene treatment. And so we have high expectations for this. And another thing, its unique feature is the digital technology that was discussed earlier. And the DSP currently have many works here. And there is a major difference that is in the DSP in the past, we were using our in-house data or the data from our own clinical develop -- clinical trials to improve the efficiency of the development. But Sumitovant is different. They use real-world data to speed up the development or the BD asset search. And also as a new -- the work that -- for the development of the digital platform, they have a digital innovator in the field. And then they look for the potential solutions. So over the past 1 year, in different departments in our company, many directions were set, although the actual solution may not have been available yet. And so lastly, as I mentioned earlier, we have the DSP's digital or the drug discovery, the experiences. And -- so we are focusing on our past experience. On the other hand, the important thing is the global development from the early time. And we are proud that we have been working on that. And so we work with Sumitovant now. And so that we have a totally different form of the business development and the drug discovery activities. And that's a new -- the potential that we have in the future. And the -- it's not just the use of the development of a new tool using the digital work that we are changing the behavior that was mentioned. And the change in the culture of the company may be possible, and we have high hopes for that. And by promoting these work, we can actually become the global specialized player. So that's the phrase. Thank you very much for your attention.

[Interpreted] Thank you very much, Mr. Kimura. Now we would like to move on to the question-and-answer session. [Operator Instructions]. So first, Mr. Hashiguchi from Daiwa Security firms, please.

[Interpreted] This is Hashiguchi, please. I have a question about ORGOVYX. GnRH antagonist has been already launched in the pact. A similar efficacy and safety profile, similar to ORGOVYX, has been already observed. However, this market was small because the dosing and administration was complicated and also the pain that patients are suffering are quite severe. The prostate cancer requires a long period of treatment. So as for the selection of treatment, I think the administration convenience is really a key -- dosing convenience is a key. When they visit the hospitals, if they can get the painless administration, I think it's quite convenient. ORGOVYX, which requires the everyday -- the administration at home, what kind of patients are actually selecting this drug?

[Interpreted] Thank you very much, Mr. Hashiguchi. So I'd like to ask Myrtle Potter to answer to your question.

Yes. The types of patients that we believe will be drawn to ORGOVYX are patients with advanced prostate cancer. And we have spent quite a bit of time profiling these patients. And we know from our research that they find the profile attractive. They find the oral dose also very attractive. And I'll ask Adele Gulfo, who is the Chief Commercial Officer, to add some other thoughts.

Thank you, Myrtle, and thank you for the question. Yes, ORGOVYX is indicated for the broad population of men with advanced prostate cancer, and we believe the drug and we are seeing the drug being used in a variety of patient population. They could be at their early stage, they could have -- they could have metastases, they could be resistant even to other forms of androgen deprivation therapy. So it's a very broad population that we're looking at, and we're especially focused on ensuring that men with cardiovascular disease are very good candidates for ORGOVYX because of the cardiovascular -- the major adverse cardiovascular event rate is very low with ORGOVYX compared to other drugs like leuprolide. So in summary, it's really for the broad population of men with advanced prostate cancer. 300,000 men in the U.S. are on androgen deprivation therapy. And we believe that ORGOVYX is an option for, I would say, most, if not all of those men.

[Interpreted] The second question is the -- when you have the Roivant agreement, you had the option for obtaining 6 companies, and you mentioned about the 5 companies, you already got the equity. And can you describe the progress of the other remaining 5 companies? And the execution of the option right is up to 2024. And currently, for the relugolix and vibegron, the launch is being looked at and so towards the close to the deadline may be the timing of the execution? Or the -- or is it possible that the execution takes place earlier? Could you also explain that?

[Interpreted] Regarding the option right execution, Nomura will give you the answer.

[Interpreted] Yes. Well, for the strategic alliance, since then, we have the options. And the information on vant -- the information sharing. Yes, we have disclosed our information. And as you say, yes, we have the right to execute the option right before -- by 2024. And currently, we have not decided what to do yet. We have some more time to consider. And so what we are focusing currently is the ORGOVYX or vibegron launch and then -- so that have the possible blockbuster after LATUDA. And that's the first priority that we need to focus on. And so regarding the option vant, we will consider a little later.

So next, Mr. Oda from Morgan Stanley, please.

[Interpreted] This is Oda from Morgan Stanley. Can you hear my voice? My first question is about ORGOVYX. Out of the top 20, you said that you had already ordered the top 10. So what about the remaining 10 hospitals? When you launching the product, I think the progress is quite favorable. Am I correct to think that way? And I think also, it's related to the application of the NHI, the National Health Insurance. And after 2021 onwards, I think you'll be able to expand the coverage. So the sales will really picking up in the late 2021, is my understanding and assumption correct?

[Interpreted] So it's about the picking up in the sales of the ORGOVYX. So I'd like to ask Ms. Myrtle Potter to answer to that question.

Yes. I would say that we are pleased with the progress that we are seeing thus far. The top accounts that I mentioned earlier showed early interest and follow-on accounts continue to come. The market access and reimbursement part of this equation also is very important and will come into play as we create the opportunity for ORGOVYX to continue to grow. So we do expect that -- the kind of interest that we've seen early on. We expect that, that will continue to grow. Adele, would you like to add anything else?

Certainly. I would add to the gentleman's comment about Medicare Part D, which is a very important part of the equation, and we've been having very good success with our -- with reimbursement discussions. And the plan is to have very broad coverage by the end of this year with most coverage being starting January of 2022. That is what we have stated, but we will see broad Medicare Part D as well as commercial coverage increase over the year as our discussions are going well.

[Interpreted] Second question. It's a treatment of PAH treatment.

Could you repeat?

PAH treatment. Phase IIb study is going on, I understand. For the schedule, after the Phase IIb study, are you going to conduct Phase III before the NDA? And also the ELEVATE study was terminated. Could you discuss the background of the termination of the study?

[Interpreted] Rodatristat ethyl, Potter will answer. Myrtle-san, please?

Yes. Absolutely. So yes, we do contemplate completing further trials after we get the initial trials for rodatristat ethyl underway. As I shared, we've initiated this study this month, and we're very optimistic that this study will go well. I will ask our Head of R&D, Dr. Sam Azoulay, to share a little bit more information around the discontinuation of the first study and also share thoughts about the future work. Sam?

Thank you, Myrtle. Yes, the first study, the Phase IIa, was prematurely discontinued. There was a problem design -- in the design of the study. The patients were not allowed to have more than 1 treatment, which was a problem. They were not -- the duration of the study was short and there was no open-label expansion. All these points have been addressed in the Phase IIb study in order to make sure that the recruitment will be made possible and as expected. So also, the team was changed, and we have a very, very experienced team, a clinical team experienced in PAH that also, through their network, have been able to identify key investigator for this trial. Yes, this study -- this Phase IIb study is still limited in sample size, 90 patients. So we will need, according to the results, to perform an additional study to complete the dossier in order to file for pulmonary arterial hypertension.

[Interpreted] About the relugolix -- this is Women Health, the endometriosis and uterus fibrosis. And I think there are competitive products by AbbVie. So before the launching, the market had a high expectation, but after the launching, actually, they are not -- very difficult to pick up. So what are the reasons behind this sort of a sluggish development? The relugolix is different from other competitive drugs. Are there any particular points that you believe that you can further grow this product going forward?

[Interpreted] So the differentiation of relugolix against the competitive products, Myrtle Potter will answer to that question. Myrtle-san, please.

Yes. So our trials with relugolix have shown that relugolix has some very distinct and very important areas that are different from the current oral GnRh antagonist. And I would like to ask Adele Gulfo, the Chief Commercial Officer, to walk you through some of those specifics.

Thank you. When you think about the differentiating features, what first comes to mind is, of course, we need the product to have a strong efficacy profile. And we do have that with a responder rate of almost 90% in patients with uterine fibroid. The other thing that physicians tell us is the drug needs to have a very favorable safety tolerability. And what's very important is, of course, bone mineral density. And we've seen in the LIBERTY trial with 52-week data that we've maintained bone mineral density. That's another distinguishing feature. Also hot flashes. That's something that women not only complain about on other therapy, but it's something that physicians tell us is very important to them because the patients continually call them because the women are suffering from hot flashes. So another distinguishing feature for relugolix combination is the hot flashes are similar to that of placebo. So you have your efficacy, bone mineral density, hot flashes and then all of that together in a convenient once-a-day dose that is the same dose for both our uterine fibroid and our endometriosis indication. So we package that all together is the compelling clinical and product profile. And a lot of it is also important is the commercial support services. So patient support in the doctor's office, making sure that there is good support for access and reimbursement. All the things that we're doing right now for ORGOVYX is what we will continue and bring that through as we're launching relugolix combination for uterine fibroids and endometriosis. So it's that whole package of the clinical, the product profile and the once-a-day dosage across both uterine fibroid and endometriosis and our commercial launch strategy.

The other thing that I would add is that we are in a very fortunate situation in having forged a partnership with Pfizer to support us in the commercialization of our women's health products in the United States. As you know, Pfizer is very experienced, and we're very, very happy about the prospects of working together with them.

Next, from the Citigroup, Mr. Yamaguchi, please?

[Interpreted] Can you hear me?

[Interpreted] Yes.

[Interpreted] I have a few questions about the relugolix in the presentation. In Europe, prostate cancer, the filing is the January to March and so, as of today, it's March 23. Do you think that you can file the application as planned?

It's about the relugolix filing in EU. Myrtle-san, please.

Sure. Please do. Yes, I'm pleased to report that, in fact, it was filed at the beginning of March. I think it was March 8 in Europe. Good news.

[Interpreted] For the commercial -- the relugolix commercial, on the Lupron, the supply is insufficient in the U.S. and instead Eligard is used. And for your commercial activities, Lupron sales reduction, is it a positive news for you? And for the Lupron Part B -- it's a Part B. And here, it's a Part D. So the reimbursement category is different. So what -- is it your strategy?

It's relugolix commercial market. Myrtle-san, please?

Adele, do you want to comment on that?

I just want to make sure I'm understanding the question. First, with regard to the Lupron shortage, we did see a Lupron shortage towards the middle to end of last year, but the Lupron shortage has pretty much now been resolved. And -- that situation. So however, during the Lupron shortage, we did see a higher utilization of Eligard. So yes, that is what we saw. Then with regard to Part B versus Part D, the androgen deprivation therapy for the past 30 years has been injectable. So Lupron, Eligard are all injectable therapies, which are Part B. We believe that oral -- because a lot of the new oral oncolytics are being widely used and embraced by the oncology audiences and having ORGOVYX, which is an oral and reimbursed by Part B, we think that together, that's a very compelling strategy, not only for patients who much prefer a pill versus a shot, but as physicians are getting much more comfortable using oral oncolytics, as they use an oral androgen deprivation therapy, we think that's a very compelling strategy. So yes, you are correct.

[Interpreted] Mr. Yamaguchi, were you satisfied with the question?

[Interpreted] May I ask one more question? please. This is a question to Mr. Kimura. So you have introduced DrugOme. It appears that you will be able to have a very efficient structure as an image aside from Sumitovant. In R&D of DSP for earlier projects, do you think that you are able to develop the product while recognizing the speed of the product? Are you going to introduce this new scheme into DSP, the DrugOme's utilization of -- in DSP?

[Interpreted] So Kimura-San will be answering.

[Interpreted] Thank you for your question. It is true that the area that we have not been able to manage is the one [indiscernible] activities, and I think -- I believe that this is very effective in activities in R&D how can we incorporate the DrugOme and we are actually asking the people to consider how we can actually introduce that. In terms of digital technology, it is not the DrugOme itself. But as was explained, the tool to find the new target, and that has been already implemented, and we use that tool to make a very effective and competitive drug discovery going forward.

[Interpreted] Mr. Barker from the Jefferies Securities.

[Interpreted] First, regarding the relugolix U.S. launch related question for Lupron injectable and [indiscernible] injectables, the doctors can get tens of thousands of dollars as income. But in the case of ORGOVYX, that's not given to those doctors. So will that affect the popularity of the ORGOVYX? That's the first question.

[Interpreted] ORGOVYX, it's about the ORGOVYX. So Myrtle-San, could you respond?

Yes. I'd be very glad to. So the team at Myovant has been very thoughtful and very careful about thinking through the contracting matter that you just spoke about, the in-office dispensing that occurs with leuprolide and other injectable. I'd ask Adele to speak specifically about the strategy that Myovant is using because you will be pleased to know that we are not at a disadvantage. Adele?

Yes. Thank you, Myrtle. That is correct. One of the first things to note about the leuprolide injection is that over the years the value that the physician makes as income on that leuprolide injection has gone down year-over-year. So they're not -- they still do have a profitable business as it relates to leuprolide injection. However, the Myovant strategy and the contracting is to ensure that physicians are not financially disincentivized to use ORGOVYX, especially, we're talking about those that have in-office dispensing for the oral agents. So they do have the ability to inject the leuprolide in their office. But more than 50% of the accounts that we are focused on in the U.S. have in-office dispensing, and we're making sure that those physicians are not at a financial disadvantage based on the contracting that we have done with them.

[Interpreted] All right?

[Interpreted] So my second question, again, about the relugolix. Recently, Phase III [indiscernible] study has begun. I think this is a clinical study to see the contraceptive effect. So the drug can be used for the treatment. And at the same time, it has the effective contraception. As for the sales, how much does this work as a positive drive?

[Interpreted] So regarding the effect of the study result of relugolix, so Ms. Myrtle, could you please answer to that question.

Yes, I'd be glad to comment. So we haven't broken out the sale on contraception and spoken about those sales publicly, but I will say that contraception study is a very important study for relugolix. Right now, our study support women using relugolix in combination with barrier method. If the contraception study were to be positive, we would have potentially the ability for patients to use relugolix without barrier metric contraception. Adele, would you like to add any other additional information?

Yes. What I would add is a couple of things. First is based on the product profile. You know that we have 100% ovulation inhibition, which was shown in our early trial, I believe, our Phase I trial. So the fact that we are moving forward with this contraception trial really supports the belief that we have in the product profile and the fact that this drug truly can be used in -- for women who are on the drug and don't want to get pregnant. So that's a very important validation for the fact that we have done that early work and now we're validating it in a larger clinical trial. And the second thing I would comment is with regard to the market research that we've done with patients and with physicians that this would be yet another very compelling, differentiating feature that we would have with our relugolix combination therapy. So we're very, very excited about getting this trial underway and with hopefully positive results in that indication.

[Interpreted] One more for the relugolix in Europe, the first indication was filed the last year in March. And then this week, I believe that they are having the meeting in the relugolix. Are you considering the filing in EMA?

[Interpreted] Myrtle, Sam?

Would you like to comment?

Yes. Uterine fibroid was filed -- was submitted last year for -- as indication. We've submitted prostate cancer this month so that the 2 indications that we are pursuing now and it will be followed by endometriosis when [indiscernible] will be ready.

[Interpreted] Is it okay?

[Interpreted] Last year, March, the first indication was filed. And so the -- I believe that the approval will be coming close. Maybe is it possible that you are getting the approval this week or very soon?

[Interpreted] Myrtle-San?

Go ahead, Sam.

Yes. It takes usually 12 to 15 months with EMA to get a response.

[Operator Instructions] So Sakai-San from Crédit Suisse securities firm.

[Interpreted] This is Sakai from Crédit. Well, I have to ask questions about ORGOVYX and GEMTESA. The peak sales of ORGOVYX is set to be more than JPY 100 billion. GEMTESA is more than JPY 50 billion. I'm sure that you all know these numbers. The proportion between the prostate cancer and the women's health, what is the proportion between these 2? And you also touched upon the expansion of indication. Will that be included in this JPY 100 billion portion? So that is my first question.

So this is the peak sales value of the ORGOVYX. So could you make a comment, Ms. Myrtle?

We have been thoughtful about commentary around our projections around both of our products. And while the analyst communities have estimates that they have come up with, we've been rather discrete about how we have spoken about the products. I will say this, in relugolix, we have a drug that has the potential for 2 claims in women's health and 1 claim in prostate cancer as well as potentially other claims in women's health. So I anticipate that we will have great enthusiasm for not only launching the claims that have already been filed but also adding additional indications as a part of life cycle management. We believe that relugolix in women's health and in oncology can be blockbuster drugs for us. As it relates to GEMTESA, GEMTESA is launching into a very active, still growing market with what we believe is a highly-differentiated label. So we believe that GEMTESA will compete very favorably, and we believe that the Urovant team there has exceptional expertise in this area, and we believe that we will see the performance be consistent with the differentiated label that we have been able to garner from the FDA.

[Interpreted] Mr. Sakai?

[Interpreted] May I ask you a follow-up question. I don't know if I use the term differentiation or not. But first and foremost, for the ORGOVYX, this does not cause the flare-up, the temporary surge is not occurred. And how it is viewed by the experts, such as doctors? And I think the -- it would be rather difficult for GEMTESA to differentiate. You said that you have a differentiating level, but it doesn't seem so. It doesn't appear so. But for example, it has less dry mouth. That could be a good point. Maybe these are the voices from the forefront. Am I correct or wrong?

[Interpreted] So it's about the safety evaluation of ORGOVYX and also the differentiation of GEMTESA. Again, I'd like to ask Myrtle Potter to answer.

Relates to ORGOVYX, we do like our safety profile. We like the cardiovascular profile relative to other available agents, and that's very important because many men who are suffering from prostate cancer also happened to have concomitant cardiovascular disease. So we believe that's very important. If you've ever spoken to a man who has been on leuprolide and experience that hot flush, that's very disturbing, it's very uncomfortable. To the extent that, that doesn't happen to the extent with ORGOVYX, that's another positive feature. As it relates to GEMTESA, we do believe our label is different. And I'm going to ask Adele to break that down for you because it's something that we're very proud of. It's supported by not only our differentiated Phase III trials, but it's also supported by meeting those key secondary endpoints when we did our trial. Adele, why don't you talk a little bit about the differentiation and why GEMTESA is so different?

Sure. And Myrtle, I just want to emphasize what you said about the testosterone flare because that is something we're hearing firsthand, and I'm even getting letters from doctors saying how their patients are so enjoying not having testosterone flare who're worried about it and not seeing it. So I did want to just validate that point that we heard. So moving to GEMTESA, one of the things to think about is, first and foremost, it is a single dose with the efficacy that you get at the starting dose, which is very important because many patients that are on therapy remain at a low dose. They don't titrate effectively. They never get their optimal dose. So one of the things that, again, a differentiator is patients will get put on therapy, it will be the single starting dose, which will be the efficacious dose, and those patients will have a response. That response that we have in the label is also something, as Myrtle mentioned in her speech, the hallmark symptom of urge urinary incontinence, that urge to have to go is very important, is a very debilitating symptom. And our drug, unlike others, will have that claim in the label for this urge urinary incontinence. A couple of other things that are very important is, as you may know, the blood pressure warning that is seen in those other drugs that are used for OAB, that blood pressure warning is a very negative effect. And physicians are aware of that, as our patients. So not having that blood pressure warning is important. And also not having the interaction with other drugs, the CYP2D6, which is a common pathway that other drugs are metabolized and many of these patients are on multiple other drugs and drugs that are metabolized through that pathway. So being able to not have to distinguish an interaction with other drugs in that pathway, very important. So in summary, it's the single dose. Also, that dose is crushable. As you heard Myrtle mentioned that we have our goal to be prominent leadership in the long-term care area, that's because that dose is crushable, and we could administer it to many of those patients who cannot take other oral therapies for their overactive bladder, and that's another very compelling differentiating feature.

[Interpreted] Sakai-San, okay?

[Interpreted] I have a question about the DrugOme, and I think it's a wonderful system, but you have just introduced this time as a model. So what is the actual case? Are we able to see -- do we have any opportunity to look at the success case or an actual case of DrugOme? Are there any opportunities that we can actually touch the success case of DrugOme? Or it's just the in-house technology? Is it going to be remained as an in-house technology, the DrugOme?

[Interpreted] This is Baba speaking. It is true that it is the internally used system. It is data-involved, so it's very difficult for us to publicize the DrugOme. But I think it's important to show everybody that we have this value of DrugOme. So I'd like to ask Bill to make a few words about this.

So I would say that we have considered in the past whether we would commercialize aspects of the DrugOme. But we -- in general, the conclusion we have reached is that we believe it represents a competitive advantage and that the competitive advantage is more important than generating external revenue off of it. But if there are components of it where we feel that there is a different answer than that, then we would consider in the future potentially commercializing pieces of it.

[Interpreted] So I think your -- the question was whether the availability will demonstrate or not. So it may be possible because of the competitors. But maybe we can show and illustrate the mechanism of the DrugOme, although it may be difficult to actually show the data.

[Interpreted] Thank you very much, Mr. Sakai.

[Interpreted] Next, Morgan Stanley, Muraoka-San, please?

[Interpreted] This is Muraoka from Morgan Stanley. Regarding the ORGOVYX economics for the doctors. The -- earlier, you mentioned that in hospital the prescribers, it's not negative. Your contract does not affect negatively on those doctors who does the in-hospital prescribing. But we are not quite familiar with the medical system or the health care system in the U.S. So could you discuss a little more about the contracts that why the doctors do not lose any profit from Lupron but switch to ORGOVYX?

[Interpreted] Yes. Thank you. ORGOVYX in-hospital prescribing, and so Myrtle-San, could you answer?

Sure. So the kind of prescribing distribution system that exists in the United States for ORGOVYX is built on physicians receiving product directly from a distributor or from the manufacturer to their offices where they dispense the drug and actually sell the drug in their office. They submit for reimbursement against a contract, and we work very hard to make certain that the contracting rates that physicians are being provided are competitive for them and don't put us at a disadvantage. I'll let Adele tell you a bit more detail about how that works. But the biggest thing we want is for the in-office economics to not be a barrier to adoption, and our indications so far are that we've achieved that. Adele, would you like to make some additional comments?

Yes, I would comment that exactly is what Myrtle says that we have specialty distributors that ship the drug to these accounts and that have in-office dispensing. They are large urology group practices, large oncology practices, academic centers. And what we have with our contracts are: number one, a discount off of the wholesale acquisition cost. So they have -- they get a discount by purchasing ORGOVYX. And depending on the volume that they purchase, they have tiered additional rebates that they could receive as they purchase more ORGOVYX. And as Myrtle said, when they get -- they submit for reimbursement, they receive for the cost of the drug, but they have the contract that enables them to be getting the drug at a discount or at a tiered rebate. So they're able to ensure that they have garnering -- they are having positive economics from the way the contracts are written and the way the drug is dispersed -- dispensed and then reimbursed.

[Interpreted] Would that be all right?

[Interpreted] So discount and rebate, for example, 30% or 50%, do you -- can you share any such information such as the rate of rebate or discount? This is additional question. Shall I ask Adele? Are you able to give us more information about the discounting rebate in terms of the number?

I don't know that it is public information that we share the actual rebate and percent discounting that we give. Perhaps a generality, I heard you mention 30%, 50%, it is way -- it is lower than that, so that it is not that sort of rebate that we're seeing that would be needed for these physicians to...

[Interpreted] Understood, understood. Just a little bit more. And again, it's about the ORGOVYX. I would like to know the current status with the indication of prostate cancer. Are you focusing on the switching from Lupron to ORGOVYX? Or are you trying to capture more new patients? So how do you operate your marketing activities?

So it's about ORGOVYX, either Myrtle or Adele, could you please answer to that question?

Yes. I would say that one of the things we think about is what we call the low-hanging fruit, which is the easy -- those patients that are brand-new to therapy, we can get them started right away on the oral, makes it easy. However, transitioning from the injection to the oral is also what we're seeing a very common practice with physicians. So I would say that, as I said at the beginning, ORGOVYX has indicated for men with advanced prostate cancer, and physicians are looking at their patient population very holistically. They're looking at those who are new to start. They're looking at men who perhaps didn't like coming into the clinic to get a shot, and they're looking at men with cardiovascular disease. So we're really seeing the physicians evaluate the overall population and choosing those patients that are right for ORGOVYX. And it is really the broad spectrum. ORGOVYX is right for many of those patients across the broad spectrum of disease and across the broad spectrum of the way that they have their preference as well.

[Interpreted] Now from Nomura Securities, Kohtani-Sama, please?

[Interpreted] This is Kohtani, 2 questions. People are quite skeptical that the -- for -- well, for the ORGOVYX, I don't think there is any reason to use the Lupron. And for the GEMTESA, I think, well, there are the elderly patients or so. I believe that there will be some. But -- so the -- why GEMTESA, the sales is considered JPY 100 billion? And so what will give -- what will help the GEMTESA to achieve that JPY 200 billion or more? And I believe -- I understand that there are competitors and so I would like to see that. And for the rodatristat, and I believe that the Phase II started, and inability to enroll was the reason. And so there were a very detailed inclusion and exclusion criteria. But for the Phase IIb study, I don't think there is major changes of that. And so I would assume that there may be some time necessary for the registrational enrollment for the rodatristat Phase II study. And so those are 2 questions I asked.

[Interpreted] And regarding the GEMTESA and then the second question was the protocol of the rodatristat. And Myrtle-San, could you respond?

Yes. I would be glad to. GEMTESA will launch into a very large market in the United States. A lot of that market is branded with a competing drug in the same class. There are other drugs in the market that are generic. But in the United States, this market is very, very large. The team has worked with the FDA to not only assure that our data from our Phase III trials is widely appreciated. The data have been presented at major urological associations. And interestingly enough, many of the things that differentiate GEMTESA from other beta-3 agonist, that data actually made it into our label in the United States, which means that our sales representatives can promote these differentiated features. And I'm going to let Adele take you through them once again to really lay out why GEMTESA is so different. I'm going to start with the simple dosing. But Adele, take it from there.

Well, I think it is important to think about the overall population, as Myrtle said. 30 million people in the United States have symptoms of overactive bladder. And last year, we had over 18 million prescriptions. So we're talking about a very big market. The value of that market is not as large because, as Myrtle said, there are a lot of generics that are being used. But these generics, as I mentioned, have -- or I didn't cover that we don't have the side effects, the side effect profile that these generics have, including things that we're learning more about the potential for dementia, the potential for blood pressure, the potential for all -- several other safety and tolerability concerns. So when you think about the profile that GEMTESA has, again, starting with the efficacy and starting with the only agent that will have urge urinary incontinence in the label, that's a very compelling clinical differentiator. Then you add to that the fact that we will not have the warning about blood pressure, we will not have interaction with other drugs that have the -- that are metabolized through the CYP2D6 system, and we will have the ability for the tablet. It's a single dose, single efficacy. So those sorts of parameters, and I've been in marketing for many years, there are things, those little simple nuances when you're launching a drug and you can say it's your starting dose, is your efficacious dose. Your starting dose is going to get patients to feel controlled with their symptoms. That's what's going to bring them back, and that's what's going to drive our uptake in our launch.

The other part of the question had to do with the rodatristat Phase IIb dose-finding trial design. Sam, would you like to speak to that?

Sure, Myrtle. So again, when you start a trial in PAH, there's a competition. So the investigator and the patient have the choice between different drugs. So a drug that offer a longer exposure, so the Phase IIb, 6 months. And at the end of the 6 months, the patient can enter into an open-label extension period. So that means the patient can stay on treatment for a long period of time, but also at the end of the treatment, get a chance to get the active treatment, not necessarily the placebo. So in addition, in the Phase IIa, the period was short, but the exam, the primary endpoint was based on the peripheral vascular resistance, which is an invasive test. So there is not that much -- it was not that much incentive for a patient to be in that study. And this Phase IIb is a completely different [indiscernible]. In addition, instead of being oblige to stop the previous treatment, the patient can continue on the current treatment. There is no change for him. There is no loss of chance. So for all these reasons, we believe that the Phase IIb will be much easier to recruit. In addition, the Phase IIa was at the beginning, unfortunately, of COVID-19, so which adds up also on the difficulties. Here, maybe if we -- if everything goes fine, the COVID-19 will be behind. But also, we took a number of measures into the protocol to make so it's -- the execution of this protocol easier with virtual visits, with much less visits, telephone visits, et cetera, et cetera. So -- and as I said, we also changed the team which -- a team which is much better connected to the investigation of sites. So for all this reason, we think that the Phase IIb will be executed as we plan [indiscernible].

[Interpreted] The next is [ Mr. Ishi ] from [indiscernible].

[Interpreted] This is [ Ishi ] speaking. About the ORGOVYX. So you have the collaboration between Sumitovant and Pfizer. What is the specific role? And also I'd like to know about the specific roles, the differentiation between Sumitovant and Sunovion for GEMTESA.

[Interpreted] So about the role differentiation of the marketing or the promotion, and Ms. Myrtle Potter will explain.

As it relates to ORGOVYX, both companies have sales representatives who are selling ORGOVYX in the marketplace. The 2 companies work together to agree on the marketing strategy for the product, the marketing positioning, with Myovant taking the lead on conducting the follow-up life cycle management work and the additional trial work that we have underway and intend to do for ORGOVYX. We're relying on Pfizer, not only to help us in the field with our selling efforts, but we're also relying on them to lend us their expertise as it relates to working directly with consumers. They've had great success with XTANDI, and they understand the prostate cancer market quite well. Adele, would you like to make any other comments about ORGOVYX?

Myrtle, you said it well. Pfizer has been a strategic partner, not only in the field as it relates to sales and account management, but also on the reimbursement side, as we're dealing with payers. They have also have years of expertise in the payer market and as you had indicated earlier. So across all of the key parameters as it relates to launch, they are a good partner for us. So yes.

And as it relates to GEMTESA and Sunovion and Urovant, we're very pleased to have the support of Sunovion, one of our sister companies within the DSP family. Sunovion will be helping us expand our primary care target audience in a very important way. They have experience with the primary care audience. They will augment our work in long-term care, urology and high-prescribing primary care. At the same time, Sunovion is also lending its support on the back end of our commercial efforts with things like distribution, contracting, et cetera. It's worked out to be a very positive relationship for us and one that we anticipate will continue to provide synergies to us as we continue our work with them. I'd also like to point out that Sunovion is also helping us on our back-end for Myovant as well, and we're very, very pleased to have their support.

[Interpreted] Now Nikkei business, Hashimoto-Sama, please?

[Interpreted] This is Nikkei BP, Hashimoto. Mr. Kimura made the presentation regarding the impact on the culture of the DSP. I have a question on that. In the past, the DSP -- well, there are some issues in the DSP before for the management style and or -- what -- there are some issues in different places. And -- but with the Sumitovant approach, do you think that you can solve such issues? If that's the case, could you elaborate on that?

[Interpreted] Kimura will answer.

[Interpreted] This is Kimura. Well, that's not the case. Well, I mentioned culture. It's not only the R&D, but the whole company, how to promote the work in the company, taking advantage of the digital technology or the rationale thinking. By having that, we believe that we can promote our work in an efficient manner. And I believe that with the help of the Sumitovant, we are currently doing that. And if that's done in the whole company, we can change our -- the way we work. That's what I wanted to mention. And as you mentioned, in the clinical trial -- to efficiently promote the clinical trial, yes, we can promote -- accelerate the recruitment of the patients, thanks to the technology of the Sumitovant. That's what we also expect. Let me confirm. The rational way of thinking for the whole company. So you mentioned that you had some issues on that in the past. Well, yes, Baba, in terms of digital will give you additional comment.

[Interpreted] For the digitalization, the -- so you would think that the efficient use of the digitalization for the better -- the efficient work, well, that's not what we are considering. We want to improve the productivity, efficiency of the productivity. And for that, behavioral change maybe -- would be necessary. That's what we think. And so we just eliminate the waste and also the look for the efficiency, but everything that, for example, how to hold the meetings or collect the information, for example, you have information in the PC, and you may take some time to search for that. It may take 10, 20 minutes. And if we can eliminate such waste in the whole company, it's quite a good, efficient improvement -- efficiency improvement. And so that's what we want to do. And we have the good -- the human resources, and so we would like to develop the rollout for the whole company. And so the -- Dan Rothman is the Chief CDO, and so maybe Dan can give a few more comments on that?

I think when we talk about behavioral change and we talk about technology, it's not that there is a problem, it's that we can move forward and advance our culture. Technology can help make things more transparent. It can help us drive, it can help us provide ways to identify value more easily for all of our employees. It can help us learn to rely on data in all of our decision-making. It can help us be more efficient in the way we execute. And so these are all things that by having the technology in place, it can also help us be more transparent and share information more broadly so that more people can participate in new ideas. And by having that technology in place, you provide the opportunity for people to think in these new ways. The cultural evolution that, that enables is not just the technology itself creating that cultural evolution, but our leadership driving us in these directions, our HR team, providing training and enabling people to be educated more as to how to use data and to how to use these tools and to how to share information more effectively and how to use the tools to identify what the most valuable choices are whether it's how we run a particular trial or how we target doctors in a sales effort, any of that, the technology can help us affect that and our people can even be more efficient and more effective through that cultural change.

[Interpreted] And so the comment and also related to the DrugOme, what we are discussing is quite abstract, and so you may think you understand or not understand. But as the deliverable or as a performance, we want to show something so that this is what we did. That's what we would like to do going forward. And just for that, it's not done by only a few people, but whole company will have that kind of mindset. So in that sense, we call it the cultural change. So please understand that way.

[Interpreted] Thank you very much, Mr. Hashimoto.

The next is [ Mr. Kakei ] from [indiscernible].

[Interpreted] Can you hear my voice?

[Interpreted] Yes, please.

[Interpreted] This is some confirmation. On Page 74 of the material about the Sumitovant product. So in the coming 10 years, Sumitovant products will support the revenues. So is ORGOVYX JPY 100 billion and GEMTESA JPY 50 billion. Are there any other products that will support the revenue source in coming 10 years? Are there any other products that you have an estimate? That's my first question.

[Interpreted] So thank you. Mr. Nomura will answer.

[Interpreted] Thank you for your question. At this moment in time, relugolix and vibegron revenue are the one that we put a lot of expectation. Of course, if there are many other -- any other items, we are very happy. But at this moment in time, we are just focusing on these 2 items.

[Interpreted] Just one more point. This may be overlapping from my predecessors. The technology owned by Sumitovant will be leveraged in R&D strategy of DSP in the future. Global specialized player is to be aimed in 2033, so you are going to leverage the digital technology. How can you utilize the digital technology? You mentioned the improvement of productivity and the value, but could you be a little bit more specific with some image for that direction?

[Interpreted] This is Baba speaking. Thank you for your question. The Sumitovant or our team in U.S. can have the expertise and the knowledge that can be brought very efficient manner in Japan as well as other regions. So therefore, we have established a data design office in Japan. Again, this is a global organization. So I think it's a good opportunity for Mr. Tatsuya to mention a little bit about this office.

[Interpreted] This is Tatsuya. As was explained, our company had already been embarked on digitalization in R&D. But now that we have the Sumitovant technology, we are able to expedite that effort, and I think it's very important. The organization that I'm belonging to is the data design office. It is not the place to use the AI. We need a design, design thinking. And also agility or agile is important, and I think we need to incorporate these perspectives in our business to go forward. First of all, we would like to focus on the -- focus to make operation more efficient. But on top of that, the innovative drug discovery is important. And of course, our ultimate goal is to change our behavior. So in the future, if we can demonstrate some specific deliverables, we would certainly love to do that. And of course, this is about the drugs, it's relatively difficult to shorten the existing process, but the shortening of the clinical trial or to increase the success probability of drug development and also to search -- to make a good search of the KOL, so in various perspectives, we would like to make operation efficient. So in terms of the digitalization, we may be able to see the results much earlier, but we'd like to continue to work on this.

[Interpreted] Thank you very much. [ Mr. Kakei ], would that be all right?

[Interpreted] One more question, please. Regarding the behavior change and the drug development, they will be combined in the future to create new valuable drugs? I believe that's the way? For the behavioral change and drug development, what will be the connection? What's your image about the link between these 2? If you have any, please mention.

[Interpreted] R&D question. So Mr. Kimura?

[Interpreted] Well, it's quite difficult to describe. The digital technology it's -- if you consider that as a technology, that may be the barrier for you to understand what we want to say. Well, data analysis, yes, that's true. But the idea will be totally changed from the traditional one, and we want to establish a business system. That's the beginning of our work. For the R&D, as you know, for the drug discovery, the probability of success is very, very low. And 20% of the sales is spent for R&D, but still, it's difficult to create a drug. And so we have to change that situation. There is a large room for improvement or the change. And by making such a big change, I can -- we can just change. But the actual work is just accumulation of small works, so it's not only one big one to change the whole thing.

[Interpreted] [ Kakei-San, ] is it okay? Thank you very much. Are there any other questions? Now that we have no more questions. I'd like to close the Q&A. But before that, I'd like to ask Nomura-San to make some comment.

[Interpreted] Now that most of the questions are asked, I'd like to make one comment. In the first part of Q&A, we received many questions regarding the commercial, and I'm afraid that many of your questions are skeptical. All the answers were -- and reactions were made by Sumitovant. As for the differentiation of vibegron or GEMTESA, how are we going to market these products and also how are we going to market the ORGOVYX. We share the strategy together, so how can we grow this potential is our main theme, how can we actually deal with the market, how do we respond to the feedback and then be able to change our behavior depending upon the response. And so I think that is the process that we are going to have this year. As far as R&D is concerned, many explanations were made. Within the governance of R&D in DSP, these matters have been thoroughly discussed, and so this is not just operated by Sumitovant and DrugOme and digital transformation. This digital innovation were tackled with these 4 key persons, Dan, Bill and Baba-San and Tatsuya-San, and these people are really thinking how to use the technology. The value has been [indiscernible]. And we had made -- we had spent more than JPY 500 billion -- or JPY 100 billion, so how can we increase the top line is the key. And also by making the operation more efficient, we have to think about how to curtail the R&D cost and what kind of deliverables we are able to convey. So these are the perspectives we need to use this DrugOme and digital innovation platform. Among the questions, there was the one that they want to look at the concrete result, and I am actually repeating the same thing to my subordinates internally. In the past, the IT was introduced to make things a little bit more convenient or useful. That's the past. And with these new initiatives, we really need to have the concrete success. So I just made the supplementary explanation. Thank you.

[Interpreted] So we would like to close the presentation and Q&A session. Thank you very much for your participation. For the participants, we have sent the e-mail for the questionnaire, so we appreciate if you can fill that. And also the movie or the -- will be -- for this will be available on the website, and also English version will be available on the website later on. And thank you very much. This concludes this Sumitovant meeting. Thank you very much. [Portions of this transcript that are marked [Interpreted] were spoken by an interpreter present on the live call.]