Johnson & Johnson (JNJ) Earnings Call Transcript & Summary

Welcome to the Johnson & Johnson 2021 Business Review Meeting, Highlighting Pharmaceuticals. Please note that today's presentation includes forward-looking statements. We encourage you to review the cautionary statement included in today's presentation, which identify certain factors that may cause the company's actual results to differ materially from those projected. Our SEC filings, along with reconciliations of any non-GAAP financial measures utilized to the most comparable GAAP measures, are also available at investor.jnj.com. Additionally, several of the products and compounds discussed today are being developed in collaboration with strategic partners or licensed from other companies. These slides acknowledge those relationships. Ladies and gentlemen, please welcome Vice President of Investor Relations, Jessica Moore.

Good morning, everyone, or good afternoon, evening to some of you joining on our virtual platform. It is a great honor to be standing before you today as the newly appointed Vice President of Investor Relations for Johnson & Johnson. I do not take for granted that I am fortunate to be starting this position at a time when so many of you are able to join in person. I look forward to our interactions today and well into the future. Now for the focus of the day. On behalf of the entire leadership team, it is my pleasure to welcome you to Johnson & Johnson's 2021 Business Review, Highlighting Pharmaceuticals. Thank you to everyone for joining us today in person and through our virtual platform. Throughout today's events, we're very excited to provide you with more insights into our long-term trajectory, fueled by our market-leading assets and best-in-class pipeline. And we are happy to provide the opportunity for you to interact with many of our leaders across the organization. We have a great day ahead of us. Leading up to today's events, we solicited input from many of you, and the feedback we received has been incorporated into the agenda. For your convenience, today's agenda can also be found directly on our virtual platform, or placed at each seat for those attending in person. In addition to the conducting of multiple therapeutic area Q&A panels, members of the Executive Committee look forward to answering your questions regarding the long-term growth profile of the enterprise, including any remaining questions that you may have on last week's announcement of the separation of the Consumer Health segment. If you have not done so already, we strongly encourage you to watch the in-depth product and pipeline overviews that were posted on our virtual platform yesterday for each of our therapeutic areas and data science, global function. In addition, on our virtual platform, you will find biographies of each speaker and the option to submit a question for our leaders throughout the day, during each Q&A session. Any resource and downloadable content from yesterday's presentations or today's live session will also be posted there following the conclusion of today's events. And lastly, you will receive an e-mail directly from IHS Markit asking that you complete a short survey so we can continue to make this business review one that you look forward to attending. Thank you all for your interest in Johnson & Johnson, and we hope that you enjoy today's events. Now let me please hand it over to Alex Gorsky to provide some opening remarks.

Ladies and gentlemen, please welcome Chairman of the Board and Chief Executive Officer, Alex Gorsky.

Well, good morning, everybody. And look, let's just give Jess another round of applause. It's not often that you get selected to be the new Head of Investor Relations at Johnson & Johnson in the middle of a COVID-19 pandemic. You have to move your family over from Switzerland. And by the way, within the first couple of months, we want to go ahead and put together a major investor relations program. But also a big shout-out to [ Jen, ] [indiscernible] the entire team, who put this entire program together, they've just done an awesome job. Thank you so much. I've got to say, it's great seeing all of you and not in a little box that just is a Zoom, but in person, being able to connect. I know it's been a long time for all of us, and so to be able to gather back here in this room is just a great experience. And we are very excited to be able to take you through our Pharmaceutical sector, but even more broadly, several different things that have been going on. Just a couple recently at Johnson & Johnson. And being able to do it face-to-face is a really nice change. We know that, that takes an effort on your part. So thank you for making the trip and investing really the time to be here, especially for an entire day. And I want to say, for those of you who are remotely, we're also glad that you're able to be here in a kind of this new hybrid way that I think we're all getting used to work -- working. And we're looking forward to just a lot of great engagement, conversation, discussion. We tried to take a lot of the feedback that you've given us in the past when we've done these events to try to incorporate it and make it as meaningful and, frankly, as relevant to you as possible. But obviously, the big reason we're here today is to talk about our Pharmaceutical business. And we've got really just a remarkable lineup of leaders who we think are going to be able to take you through a lot of the details and really dimensionalize and bring to life the long-term growth potential that we see. And I think what's most important is that you actually hear it from them, the people who are doing the real work each and every day to make all this possible. Now look, the first thing I want to acknowledge as we get going today, after having talked about them for a moment, is just the fact that, look, this is kind of a big day for me. This is going to be the last time that I'll be doing an Investor Relations Day as the CEO of Johnson & Johnson. And look, as I stand up here, I got to say that, by far, it's been one of the greatest privileges of my life to lead this incredible organization. I never would have dreamed more than 30 years ago, when I started with this company as a sales representative back in 1988, that 32 years later, that I'd be standing on this stage, reflecting back on nearly a decade that I spent as the company's CEO. And for me to just say that I'm proud of what we've done, that'd be the wildest understatement that I could imagine, because it goes far beyond that. This is a family. This is a huge part of my life. And so to have this opportunity is just awesome. And I'm glad that I get a chance to share it all with you. Now I'm getting asked a lot of times these days, so what do you think has been maybe one of your most important accomplishments? Or what do you really reflect back on during this time? And gosh, I could go on for probably the next 4 hours on that. But if I boil it all away, it really starts with what's in the entrance of this building when you first walk in with the credo that's right there on our wall, and that unwavering commitment through thick and thin, through twists and turns, through ups and downs, even through COVID-19, that we always stay true to those principles of looking out for the interest of all those stakeholders at the same time and doing that while we're working to fundamentally change the trajectory of health for humanity. Now as I look forward, because I'm not riding into the sunset, I'm going to be around for a while, and I'm eager to contribute in my new role as the Executive Chairman, working alongside our Board of Directors and very much with Joaquin in his new role as CEO. And I got to tell you, I couldn't be more excited about the future, knowing that Johnson & Johnson will be led by Joaquin. He's somebody that I've worked with for decades in Europe, in the United States. He's somebody that's worked across sector. And I've always been impressed. From the first time that I met him decades ago about this unique combination he has to be able to frame the strategy, but dive down into the details of our business and do it in a way that has empathy and understanding of the people in the organization. And that combination, as we know, is so unique and so important in a leader particularly in a company the size, the scale, the scope of Johnson & Johnson. And look, most importantly, he is someone who is also deeply committed to our credo. I mean it's part of who he is. And his history in the company and helping to shape that culture, I know that it's going to continue to be in wonderful hands with Joaquin. Now I'm also pleased because I think Joaquin's stepping into this role at a time, in many ways, our company, our business and even our people and our culture has never been stronger. And well, today, you're going to be hearing a lot of different highlights about our pharmaceutical sector. As you heard even last quarter and recent updates, the rest of our businesses are also performing incredibly well. We're constantly and consistently delivering right now on innovation, on excellence in execution, on strong, decisive leadership. And while we've been doing that, we've also been delivering strong, dependable returns for our investors as well. We've kept up a very strong pace of acquisitions and divestitures. And through it all, we have even put the pedal down more when it comes to investing in research and development all for the future. In preparing for today, I couldn't help but look back at their remarks on 2019, because I know all of you would, as you were getting ready for your questions, and say what were some of the familiar themes that we had back in 2019 and how does it compare or contrast to what we're talking about today. And I think I got it right back at that time. We've talked first about this pivotal really important role of innovation, the need for even more partnership and collaboration across the industry. A growing importance of global public health, and an acknowledgment, even at that time, that there were some fundamental flaws in our health care system, and not only here in the United States, but around the world, that needed to be addressed. But I don't think any of us, any of us, could have imagined just how important and what a sense of urgency there would be around those issues -- were about to become when our life changed in such a fundamental way with COVID-19. I mean, if you think about it, I would offer that this pandemic is likely a once in a generation kind of convergence of opportunities, challenges, that are going to impact not only this industry but our lives. For the rest of our careers, we'll be saying, remember when this occurred. And how that works its way into the dynamics of what we do, I think, is going to mark an inflection point for all of us. Now our family, our colleagues here at Johnson & Johnson, heard a bit of a clarion call and worked faster, likely harder, than ever before in their careers to develop a safe, effective vaccine that's easy to distribute, that we believe is going to continue to play a very critical role in ongoing public health efforts around the world. The existence of a single shot, easy-to-distribute COVID-19 vaccine that we're continuing to provide on a not-for-profit basis, well, it's going to be crucial to vaccinating the global population, not just certain parts of the population. And we're continuing to do our part for the global good because we're not going to be through this pandemic until we get many, many, many more patients vaccinated around the world. Now I would really be remiss if I didn't acknowledge another critical leader at Johnson & Johnson, Dr. Paul Stoffels. You saw him come in at the last minute, that's because he was working on that last submission to the NME likely, because he really knows what's most important. No, but as you all know, Paul is going to be retiring from Johnson & Johnson at the end of this year. And I don't think we could find a stronger advocate for solving some of the world's toughest, thorniest, most challenging health care problems than Paul. He truly embodies and represents the very best of Johnson & Johnson. Let's think about it for a moment. If we reflect back over the course of his career, and he's done so many things. And then just recently to be spearheading the company-wide mandate, okay, to -- with the vaccine, but that built on decades of leadership where he always was trying to find transformational breakthroughs in therapeutics and medicines and solutions. He led a remarkable revitalization of our pharmaceutical pipeline. And I think you'd all agree, created one of the leading, most robust portfolios across the entire industry. His remarkable legacy, well, it's created life-changing products and medicines, and not only for the developed world but for people all over the world. And I think COVID-19 is a great representation and culmination of so much of what he's done. Now on top of all that, and those of you that know Paul, I think, would attest to this as well, in addition to being one of the world's truly great scientists, he's just an awesome human being. And I know that we, I certainly, would not have been able to accomplish what I have without his partnership, without his friendship. And he's going to leave a lasting, enduring impact on the culture, people development, that entrepreneurial drive, that sense of urgency, that restlessness, that commitment for patients, certainly at Janssen and all of Johnson & Johnson. Thank you, Paul. Now we believe right now, as I mentioned earlier, that this is a unique time, and we think health care somewhat as a result of the pandemic, but also because of what's happening in science and technology now is really poised to assume likely a more central, a more important role in creating a better future not only for the world, but particularly for Johnson & Johnson and the important role that we believe that we can play. We think it's a fundamental turning point for the industry and for our company. I know there's a lot of different ways of looking at the world right now. And if you just listen to the television, it can lead you to a pretty dark spot. But what we would argue that if we look at some of the key underlying economic indicators, the fundamentals are strong. And there's no question, that deferred care, delayed care that hasn't taken place over the last few years because patients have put it off or health care systems have not been in a position to be able to provide it, is going to generate and create significant underlying demand, at least for the next several years. We think people have an improved appreciation for how important health care is. And we believe they're going to come out of the pandemic even more motivated to take a more central role in their own health care, that of their families, to improve their health and their well-being. And we certainly believe that nobody, no other company, is better positioned to address this than Johnson & Johnson. So now let me talk for just a minute about our future. And you've heard me say this before, but at Johnson & Johnson, while we're pleased, we are never satisfied. We always want to do more. And the more uncertainty and disruption that we face in the world, it's more important for us then to continually ask ourselves what we need to be doing to make sure that Johnson & Johnson is going to flourish and make a difference for the next 135 years. We're proud of our iconic history, but we're not iconoclast. We want to make sure that we are set up in changing and challenging ourselves always for the future. And in these times, thinking back to our credo, it is our biggest source of inspiration. It's clear about our obligation to do everything we can to position our business for long-term success. And that's not just for our stakeholders, but that is for all of humanity. And that brings me to last week's announcement to separate our Consumer Health company and establish a stand-alone publicly traded business, while continuing to operate our Pharmaceutical and med tech businesses as the new Johnson & Johnson. As I'm sure you can appreciate, our Board and executive team evaluated Johnson & Johnson's portfolio of business through the years, and we always asked and challenged ourselves, our broad-based approach, if that truly met the best long-term needs of all of our stakeholders. And while this approach undoubtedly served us well for decades, addressing some of the most complex issues in health care around the world, we believe the consumer environment today now demands a different kind of focus on innovation and agility. Now we believe that this bold action to evolve our business will better position both businesses to win, deliver for stakeholders and continuing to advance our overall mission for decades to come. And by pursuing even more targeted business strategies that's going to enable each stand-alone company to accelerate growth, the new Consumer Health company and Johnson & Johnson, well, we think they're even going to be better positioned to deliver improved health outcomes for patients, consumers, and ultimately deliver even greater value for our shareholders. Now everyone is here for our Pharmaceutical Business Review, and we've got a lot to discuss. And since we held our last meeting, gathering the trajectory of our pharmaceutical sector, well, it's gone from strong to, we believe, even stronger. We're making consistent strides towards winning the market everywhere where we compete and we're achieving that by keeping the patient at the very center of what we do. You can see that we're merging scientific and medical insight to really deliver a multitude of differentiated compounds and health care solutions, and really fundamentally change the way that we think about the way diseases are prevented, intercepted, treated and even, in some cases, cured. And just as we've demonstrated, that we've got a broad and diverse portfolio that's not built on a single compound, but many different products and technologies, what I'm equally proud of is the people you're going to hear from today. The people actually doing the work, making this all come to life and our deep bench of scientific and technology expertise and leadership. We've got a truly exceptional global leadership team. They are experts in their fields. And we think that while market dynamics and new sciences and technologies are going to come and go, the kind of stability that they provide will ensure that we make a big difference for patients and continue to lead in all of these fields. Finally, I just want to say that I could not be more optimistic about our position today, but also for years to come. We are better positioned than ever to seize on what we believe is this golden moment in health care and to really amplify and accelerate the impact that we believe we're going to have on patients and customers around the world. And while a lot has changed for all of us, personally, professionally since we stood here in May of 2019, our rock-solid confidence in our Pharmaceutical business and team and science that you're going to hear about today is not one of them. There's a tremendous amount of excitement about combining skills, and expertise from our pharmaceutical group and our medical device group to really bring integrated, more comprehensive solutions to health care, as well. And we're just getting started. So thanks so much for being here today. We've got a great program put up to you. We appreciate your interest in Johnson & Johnson and your trust, and we're taking the actions to drive better outcomes for patients and consumers, and ultimately, creating more shareholder value. With that, I couldn't be happier than to turn things over to Jennifer. Thank you very much, everyone. [Presentation]

Executive Vice President and Worldwide Chairman of Pharmaceuticals, Jennifer Taubert.

Good morning, and welcome, everyone. I'm Jennifer Taubert, Worldwide Chairman of the Janssen Pharmaceutical Companies of Johnson & Johnson. And we are really please to be able to host you live today. The video you just saw is a great characterization of the commitment to those we serve. Janssen Never Stops is a mindset our more than 40,000 colleagues have embraced as we deliver for patients around the world. I know I speak for our entire team when I tell you how excited we are today to have you here and be able to update you on our Pharmaceutical business and on our pipeline. Since we last met in May 2019, we have continued to deliver transformational medicines that help improve and save lives. And during this time, we have also delivered outstanding business results. And really, importantly, we have made significant progress in advancing our pipeline as we look to a very bright future of delivering for even more patients. I hope you had the opportunity to view our on-demand presentations from our therapeutic area as a lead-in to today's program. Over the course of the day, we're going to feature 4 spotlight presentations that focus on some of the very promising, exciting new programs that you've told us you are really interested in learning more about and that we believe are going to be really important drivers of our future growth. So these include our BCMA CAR-T program, how we plan to lead in lung cancer, our plans to address autoantibody-driven diseases with nipocalimab from our Momenta acquisition, and also our retina program. Our objective today is to give you a very clear understanding of our growth expectations, the potential that we have for our differentiated marketed brands, how we plan to deliver on our pipeline, our breakthrough science that's going to drive our near- and long-term growth, and really importantly, why we are so confident about our future. So let's start with what we would like you to take away from today. First and foremost, we are a transformational medical innovator, focused on delivering life-changing therapies for patients. As a leading biopharmaceutical company, the plans that we'll cover today gives us really great confidence that we're going to be able to deliver above market compound annual growth of at least 5% through 2025, with growth expected every year. Driving this growth is going to be our portfolio of industry-leading brands, our currently marketed brands with 8 expected to deliver double-digit growth and with 14 exceeding sales of $1 billion. In addition, our robust pipeline will deliver approximately 50 transformational medical innovations, both expansions of existing products as well as novel therapies. We anticipate 36 product expansions with the 10 largest achieving peak year sales of more than $1 billion. In addition, we're planning for around 14 novel therapies, each with more than $1 billion potential, and 5 with $5 billion potential or more. And looking through the 2020 -- looking beyond the 2025 horizon, our breakthrough scientific approaches and pipeline will help advance our next wave of innovation. By 2025, we expect to be a $60 billion pharmaceutical company. And we are confident we'll be able to deliver transformational medical innovation that enables this level of sustainable, above-market growth. As we emerge from the pandemic and look ahead, we see a pharmaceutical market with a total value estimated to reach about $1.6 trillion. In addition, the type of scientific advances you're going to hear from us today, we are also at the forefront of trends that are shaping the health care environment and transforming the patient experience. Things like personalized medicine, digital technology and data sciences to name a few. Industry growth is estimated to be about 3% through 2025. And we are well positioned to outperform our competitors and deliver above-market growth during this period. At Janssen, our transformational medical innovation, world-class capabilities and patient-centric approach have resulted in a decade of significant business growth. Over the past 5 years, we've grown at a rate more than twice that of the market. As a result, we're one of the leading pharmaceutical companies in the world. And our portfolio of marketed medicines leads the industry in a number of brands with more than $1 billion in sales. We've been able to deliver consistent above-market growth because we've got an innovation-based strategy and a very strong foundation, comprised of deep scientific expertise, world-class capabilities and a source-agnostic win-win approach to external innovation. We disproportionately invest in R&D. In 2020 alone, we invested $9.6 billion, making us one of the top investors in R&D across all industries worldwide. This is more than 100% more than we spent on sales and marketing. Our world-class capabilities are backed by very strong commercial leadership and global reach. And our global market access capabilities enable us to demonstrate the value of our medicines and to gain broad access throughout the world. This is underpinned by our robust supply chain with consistency in manufacturing and distribution around the globe. And we have a strong track record as a partner of choice for external innovation. In fact, about half of our innovation is sourced externally. And we continue to see about half of our pipeline value coming from licensing agreements, partnerships and acquisitions. We are also proud of our leadership in all that we do. Guided by our credo, we've set a high bar for transparency of our pricing and business practices. And our annual U.S. Transparency Report has become an industry model. We follow responsible global pricing and access approaches around the world. And as the largest and most broadly based health care company, we use our voice to advance the dialogue on policies to help protect innovation and to drive greater patient access. We are also working to do our part to help eliminate health inequities for people of color through our Johnson & Johnson Our Race to Health Equity initiative, which includes a $100 million financial commitment and emphasis in areas like ensuring diversity in clinical trials and partnerships with associations to help address health disparities. And we believe in investing in global public health, to help improve the lives of people around the world, in areas where we can make a profound difference, areas like Ebola, HIV, tuberculosis and COVID-19. Following a decade of strong growth, one question you might have is, can we keep it going, right? Patent expiries and loss of exclusivity are a normal part of the pharmaceutical business life cycle. It's important to let you know we take a thoughtful and rigorous approach to planning to ensure continued growth, even in the face of potential expiries. We do this by maximizing the value of our currently marketed medicines, continually strengthening our pipeline and relentlessly seeking the best science and partnership opportunities to drive even greater growth. We've demonstrated with REMICADE we can continue to grow despite LOE impact, and we're prepared to do the same through anticipated loss of exclusivity in the future. Today, we are in an even stronger position than we were 5 years ago. As a result of our actions, our key marketed medicines will continue to fuel significant growth throughout the 2025 time horizon. In addition, we have accelerated the timing of key assets in development to enable filing and launch during this period. And we've made strategic additions to our pipeline in immunology and in other therapeutic areas that will contribute both near term and midterm, so we can continue to drive growth and more than offset any potential LOE impacts. There are not many companies that can deliver above-market growth in the face of anticipated loss of exclusivity. We're confident we will. So here's how. We're focused on 3 primary catalysts that we believe will propel our above-market growth through 2025. First, we're going to drive growth through our diverse, industry-leading portfolio. Second, we're going to deliver on our robust pipeline of transformational medicines. And third, we're going to continue to advance our next wave of innovation as we work to ultimately prevent and cure disease. So let's dive a little deeper into each. [ Robin, ] a little bit of water first. Okay. Thank you. With 13 of our currently marketed medicines across 6 therapeutic areas anticipated to deliver and exceed $1 billion by 2025, we're going to drive growth through additional share gains and increased penetration into our indicated populations. This includes some of our key growth brands such as DARZALEX, IMBRUVICA, ERLEADA and TREMFYA. We're planning significant additional expansions for these products and others, and we expect to file around 36 by 2025. These include new indications, additional lines of therapy, combination regimens and new formulations that meaningfully advance the standard of patient care. So here's a list of some of the top examples, many of which will deliver peak sales of $1 billion or more. And it's important to note, these are largely derisked because these products are in the market today and we've got really good insight into their overall profiles. So I'd like to focus on the potential of a few of these, starting with 3 of our leading oncology medicines. Since its launch in 2015, we've established DARZALEX as a next-generation backbone therapy in multiple myeloma, driven by 10 approved indications. Today, DARZALEX is approved in almost 100 countries and the brand continues to penetrate earlier lines of therapy. Two near-term growth drivers for DARZALEX include DARZALEX plus REVLIMID and dexamethasone in frontline multiple myeloma, and our FASPRO subcutaneous formulation. Recently, data for DARZALEX plus REVLIMID and dex demonstrated an impressive progression-free survival improvement of nearly 30 months versus REVLIMID alone. And the FASPRO adoption has been even better than expected, and now makes up more than 60% of our volume globally. And in the U.S., FASPRO adoption is already around 70%. Additional drivers of growth for DARZALEX include our study of adding DARZALEX to VELCADE, REVLIMID and dexamethasone for nontransplant patients; and separately, in newly-diagnosed transplant patients, as well as treatment in smoldering myeloma. DARZALEX is transforming the lives of patients living with multiple myeloma and is a strong platform for further growth. Next is IMBRUVICA. IMBRUVICA is the first and most comprehensively studied BTK inhibitor. IMBRUVICA has 11 indications -- excuse me, 11 approvals across 6 indications, and is approved in more than 100 countries. It's been prescribed to treat more than 0.25 million patients worldwide. And IMBRUVICA is the only BTKi to have demonstrated overall survival in chronic lymphocytic leukemia, with a proven safety profile through 8 years in CLL. In terms of future growth, new promising data for IMBRUVICA in CLL is the first all-oral, chemotherapy-free, fixed duration combination with venetoclax has been presented, with the potential to set a new standard in fixed duration therapy, delivering transformational, progression-free survival with the ability to stop treatment. And a total of 5 potential new indications are planned for submission that will support IMBRUVICA utilization. We remain confident in IMBRUVICA's continued growth potential. Since launch, ERLEADA has become a great growth driver for us with significant uptake in patients with metastatic, castrate-sensitive prostate cancer and nonmetastatic, castrate-resistant prostate cancer. ERLEADA is currently approved in more than 70 countries. The strong uptake in advanced disease is driven by a differentiated clinical profile, providing patients with the longest overall survival and a favorable quality of life profile that includes no added fatigue. Looking forward, ongoing clinical studies with ERLEADA are going early in the treatment spectrum into localized prostate cancer. Early use is all about giving prostate cancer patients the best chance of cure. Men with localized prostate cancer represent the largest prostate cancer patient population with high unmet need as many patients progress after local therapy, surgery or radiation. We're working towards ERLEADA being the first to market with the only registrational trials in this setting. We're studying ERLEADA here to significantly improve the cure rate for patients with high-risk localized prostate cancer. ERLEADA will continue to be the backbone of prostate cancer treatment and we are investing to expand into earlier treatment areas. So now let's turn to immunology and TREMFYA. TREMFYA is our first-in-class IL-23 inhibitor with a distinctive clinical profile, and TREMFYA is approved in more than 80 countries. Today, in psoriasis and psoriatic arthritis, TREMFYA delivers on all 3 of the most important prescribing attributes. First, complete skin clearance. Across multiple programs, including head-to-head trials versus Humira and COSENTYX, TREMFYA shows a majority of patients achieving PASI 100, a measure of completely clear skin. Second is durability. Patients with psoriasis want confidence that their efficacy is going to last. TREMFYA's durability is unmatched, with 84% of patients maintaining PASI 90 over 5 years. And TREMFYA is the first IL-23 inhibitor approved in psoriasis and psoriatic arthritis, and is the only IL-23 demonstrating inhibition of structural damage in a pivotal Phase III trial. Looking ahead, we are excited about TREMFYA's potential in Crohn's disease and ulcerative colitis, diseases with enormous unmet need. Despite these advances today, less than 10% of moderate to severe patients are in sustained clinical remission and TREMFYA has the potential to transform IBD outcomes. We just announced results of our Phase II Crohn's disease trial, showing 65% of patients treated with TREMFYA attained clinical remission through 1 year. This level of clinical remission at 1 year has not previously been seen in pivotal trials. With Janssen's distinctive leadership in IL-23 pathway science, we are poised to win for patients with TREMFYA. And I hope you'll agree, our key growth assets have a lot of runway. The second reason we're confident in our ability to deliver above-market growth is our pipeline. Here's a selection of the near-term assets we are particularly excited about. We have approximately 14 novel therapy filings across our 6 therapeutic areas anticipated between 2021 and 2025, with peak year sales exceeding $1 billion and 5 with the potential to exceed $5 billion. Very significant assets. And you'll notice a number of these are new since our last business review. Mathai is going to talk about several of them today, and we will also cover 4 more in depth during our spotlight sessions. Our third driver of growth is the next wave of innovation as we're really working on today to deliver our future transformational medicines. Since the last time we met, we have advanced several of our programs and are leveraging a number of new technologies and platforms, such as our CAR-T cell therapy program and our entry into gene therapy with a focus on retinal diseases. We believe these can be game changing for patients. And we're never done. We expect to file at least 65 potential transformational medical innovations between 2026 and 2030. We never stopped scouting the external environment for the best science and the best in partnership opportunities for our next wave of innovation. We understand the importance of being an integral part of the innovation ecosystem, and we have built a strong reputation of being forward-looking and open to new ideas wherever they originate, and we remain both source and modality agnostic. We're going to continue to lead in this area and remain a partner of choice for the best opportunities to continue to enrich our pipeline. So I would like to close where we began, with our growth expectations over the next 5 years and the reasons we are so confident in our ability to continue to deliver. Through 2025, we anticipate above-market compound annual growth of at least 5%, with growth expected in every year. We expect 8 key brands to deliver double-digit compound annual growth rates and to have 14 brands with sales exceeding $1 billion. Over this period, our robust pipeline will deliver around 50 transformational medical innovations, including 36 product expansions, and importantly, we are planning for around 14 novel therapies across our therapeutic areas, each with more than $1 billion in potential and 5 with $5 billion potential or more. And by 2025, we expect to be a $60 billion pharmaceutical company. I hope you'll agree with this focus on transformational medical innovation to address a serious unmet need, our portfolio of leading medicines, our robust pipeline and our world-class capabilities, we are well positioned to deliver sustainable above-market growth through 2025 and beyond. We feel privileged to do what we do each day, transforming the lives of millions of patients around the world. So thank you very much. And now I'm pleased to turn it over to my colleague, Mathai Mammen.

Ladies and gentlemen, please welcome Global Head of Janssen Research and Development, Mathai Mammen.

Thank you so much, Jennifer. Good morning, everyone. I've really been looking forward to today. I've been looking forward to unveiling for you a really deep pipeline of transformational medicines. And I'll describe a strategy that you'll agree has been working and is different from that of other pharmaceutical companies. You'll also meet some of our top leaders and understand what we mean when we say world-class team. You're going to be impressed. So Alex spoke passionately about J&J's credo. These are the principles by which we operate. They're not just words on walls, but they're felt. The mission that we live every single day is to have a profound impact on human health. At Janssen R&D, we think equally of science, of unmet need and of access. We think of market access early in clinical development, creating the right evidence sets as regulatory approval now is sort of the halftime show. We know that medicines and vaccines are only impactful if patients receive them, they can access them. Each medicine in our portfolio, you'll see, has to prove itself truly transformational. That's a high bar. If we find ourselves pursuing a project that doesn't meet this high bar, we promptly and dispassionately refocus. Of course, this mission is our legacy. We have a really remarkable track record of productivity momentum with 20 new medicines in the last 10 years, with many of these being first or best-in-class. And our mission is also global. It's deeply rooted in impacting health all around the world, of people everywhere. Through our global public health efforts, we continue to act in the legacy of our namesake, Dr. Paul Janssen, in our commitment to end tuberculosis. This is the world's top infectious killer. We've treated more than 400,000 people with SIRTURO, with unprecedented efficacy and more than 150,000 in low-income regions with our HIV therapies; reached hundreds of thousands with our Ebola vaccine. And as you know, we're on a mission to help vaccinate the globe with our easily used and effective COVID-19 vaccine that demonstrated during our real-world evidence in Phase III studies, long-lasting protection against COVID-19-related hospitalizations, with the majority of our doses in 2022 going to the African Union and countries supported by COVAX. We have a deep, diverse and robust pipeline that will deliver enviable, consistent, near- and long-term growth and meaningfully impact so many patients around the world. As you've heard, by 2025, we expect to file roughly 14 new breakthrough products, with 5 of these having peak year sales of more than $5 billion; and roughly 36 significant product expansions, with the top 10 averaging peak year sales of over $1 billion. That's 50 or more transformational therapies. And this new momentum will only increase in the second half of the decade where we expect to go from 50 to more than 65 transformational therapies. So we are indeed delivering. But the why is important, why are we confident? We run a unique combination of a disease-focused and biological pathway-focused model with truly end-to-end therapeutic areas, working side-by-side with world-class global functions; a highly effective, integrated data science and digital health global function driving tangible impact on our programs; a humble yet discerning position within the global innovation ecosystem as a partner of choice. We don't simply offer dollars, but each part of us offers skills, insights and a spirit that partners can't find easily. And our industry-leading teams whom I'm particularly proud of, our leaders are awesome and make everything you'll see here today possible. We'll get to the specifics of our R&D engine shortly, but first, let's turn to our full development portfolio. This is a very active landscape. The pipeline you see here is vast and it's managed carefully and kept intentionally diverse along important axes. This way, we manage dependent risk. Our portfolio spans 6 therapeutic areas, spans specialty care and primary care. We go from acute to chronic diseases, and have rare and common diseases. We are also, proud to say, in the midst of a step change in productivity. For most pharma, delivering a big new product every single year consistently is an accomplishment. But for Janssen, we've historically exceeded that rate, delivering 4 transformational novel therapies every 3 years as shown here. We're now on track for a rate of 8 big new products every 3 years through 2025. And it gets even better. This productivity is expected to keep increasing. We expect this rate of filing of novel therapies to go above our already aggressive near-term growth through 2025, with 10 or more novel therapies in the 3 years between 2026 and 2028. I just shared that we expect 14 novel therapy filings by 2025. These, I want to emphasize, will be big products. They have an average peak year sales expectation, among these 14, of $4 billion on average. And many of them may exceed that figure. We expect 5 of these to be products that will have peak year sales significantly more than $5 billion. This includes CARVYKTI, which has the potential to be the best treatment for all stages and forms of multiple myeloma; RYBREVANT in combination with lazertinib, with the potential to replace the standard of care in EGFR-positive, non-small cell lung cancer; and our TARIS local delivery system for bladder promises to create a very high-impact platform. Nipocalimab, our pipeline and a product with 10 or more indications for rare and common diseases. And finally, our Factor XI inhibitor, milvexian, aims to be the next-generation safe and effective anticoagulant. So in addition, let me highlight a few more here. In oncology, we've been a pioneer and innovator in the CD3 redirector space, and our data now for teclistamab and talquetamab are looking really promising. Niraparib is our PARP inhibitor developed in a logical biomarker, science-driven way for prostate cancer. In neuroscience, seltorexant and aticaprant, our Orexin-2 and kappa-opioid receptor blockers, respectively, and are being developed in unique ways for important biological subsets of patients with depression. In immunology, bermekimab is a potential first-in-class IL-1 therapy for atopic dermatitis and hidradenitis suppurativa. And we're developing an incredibly exciting oral IL-23 receptor antagonist for a range of autoimmune conditions. Our vaccine space is going through an inflection point right now with RSV now coming forward. And I'll tell you more about our exciting retina space in a moment as well. The same potential exists for our currently marketed medicines. Our team applies the same biological and medical creativity and energy to make our marketed products maximally impactful, and we expand their use into new patient populations. We expect roughly 36 additional filings for indications expansions by 2025, expanding our medical reach. Many of these have more than $1 billion sales potential, and 4 of our currently marketed products have the potential to add over $2 billion in incremental peak year sales due to expansions filed in this time frame. This includes TREMFYA, where we continue to expand our impact in Crohn's disease and ulcerative colitis; and DARZALEX, where we're expanding into frontline, multiple myeloma therapy for multiple indications. So a moment ago, you saw a range of new potential blockbusters. Let's look at a few examples that we're especially excited about. Let's begin with CARVYKTI. This is a BCMA CAR-T therapy in a key aspect -- part of our journey towards a cure of multiple myeloma. We believe this medicine is best-in-class, showing some of the most incredible data I've ever seen professionally. Patients with relapsed refractory multiple myeloma were enrolled. These patients have a life expectancy of a couple of months. They were literally at the end of the line. The median duration of response is now 22 months and is expected to rise further as the trial continues and the data mature. We saw an over 80% stringent complete response rate in this trial. And with better drug tolerability through delayed onset of cytokine-release syndrome, we're running clinical trials both in inpatient and importantly in outpatient settings. The outpatient setting here could be a huge win for patients and caregivers. You'll hear more on this from Peter, Remo and Scott. Next, there's RYBREVANT in combination with lazertinib. We're especially excited about this given RYBREVANT's approval earlier this year and our move into lung cancer. RYBREVANT is the first fully human bispecific antibody in lung cancer and the only approved IV therapy for non-small cell lung cancer with an exon 20 insertion mutation. The antibody is interesting. It binds to both EGFR and cMET on the surface of the cancer cell. CMET is a common resistance mechanism that the cancer typically uses to bypass EGFR inhibitors. So hitting both targets at the same time deepens response by cutting off that resistance path to the tumor. Now combine that with lazertinib, a differentiated, brain-penetrant next-generation EGFR tyrosine kinase inhibitor and you have a 1, 2, 3 punch against EGFR-mediated non-small cell lung cancer. This is a large opportunity in EGFR lung cancer and will anchor us as we continue expanding here. And we're planning to create a disease transforming portfolio, much like we've done for multiple myeloma and prostate cancer. You'll hear more on this today from Peter, Vanessa and Rich. Let's turn to our newest goal, the complete transformation of bladder cancer treatment. We have a bladder cancer experience already with Balversa, the first FGFR inhibitor for urothelial cancer. Our strategy is to treat bladder cancer early to yield better outcomes. Many of these early tumors are expected to respond to FGFR therapy. However, patients with early tumors like non-muscle invasive bladder cancer, they may be less tolerant or willing to tolerate the side effects of typical cancer-systemic cancer therapies. So in true Janssen fashion, we completely reimagined treatment, predicting that localized therapy would be the best possible approach to localized cancer. The TARIS system is a small, pretzel-shaped tubular device that releases drug from within it in a very precisely controlled way. We use the TARIS system with gemcitabine first, where we've generated an overall response rate of 50%. We're working now to expand this novel approach by first combining it with our own PD-1 inhibitor, cetrelimab, to create a really high-impact regimen. We're then creating a TARIS system that releases Balversa itself, driving efficacy even deeper. We believe this bladder drug delivery system will yield multiple regimens for bladder cancer, and we won't stop until we've cured bladder cancer. Now let's look at nipocalimab, our pipeline and a product from our recent acquisition of Momenta. You'll hear more about nipo today from David, Terry and Bill. This is our first drug in autoantibody-driven diseases. So in these diseases, pathology-causing antibodies are at the root of this autoimmune class. There are more than 70 of these known diseases affecting as many as 2.5% of the world's population. So this important access of immune pathology has no medicines at the moment, but we intend to change that. Nipocalimab works on the theory that clearing pathological antibodies from the blood benefits patients. It does so by inhibiting the natural retention mechanism of IgG, FcRn, allowing IgG that causes pathology to be eliminated more quickly than it would be otherwise. We're developing nipocalimab for generalized myasthenia gravis, where we've already seen strong data. We're also running first-in-class registrational studies for hemolytic diseases of the fetus and newborn and warm autoimmune hemolytic anemia, including trials where the primary endpoint is measured in the number of live births. What's exciting is nipocalimab's potential to impact a whole constellation of patients across 10 or more indications, spanning rare diseases and common diseases in multiple therapeutic areas. Next, we have a product that prevents respiratory syncytial virus infection. RSV affects 64 million adults worldwide. Our vaccine is the first to demonstrate high clinical efficacy with high levels of protection against both RSV A and RSV B in adults over 65, and we plan to file next year. We have a comprehensive RSV program that includes vaccines and therapeutics. Now let's turn to gene therapy, where we have our first product coming in retinal disease with AAV RPGR. We committed to retinal disease a few short years ago. And since that time, we built a really strong portfolio in both rare diseases and common diseases and built a world-class team. We're actively screening our patients in our Phase III program with our first gene therapy for X-linked retinitis pigmentosa, this is a rare retinal disorder that causes blindness. Initial Phase I/II trial showed the potential to deliver a significant improvement in eye function and a significant increase in the quality of life. We've worked closely with our partner, MeiraGTx, to develop this therapy and are confident this work, the totality of it, will pave the way for other gene therapies at Janssen. Jim, Vanessa and Najat will share more about this and our entry into this space. And lastly, milvexian. This is the first potential oral Factor XI inhibitor that we're developing with our partner, Bristol-Myers Squibb. This program builds on insight and genetics suggesting that inhibiting Factor XI potentially offers strong efficacy with a wider safety window compared to current anticoagulants. Such a product is a much needed option where there are concerns of bleeding. We're -- we've achieved exciting efficacy and safety results in a Phase II trial in total knee replacement versus enoxaparin, and now we await the results of a second large Phase II trial in secondary stroke prevention next year. All of these exciting programs represent substantial near-term potential. But we have a lot more that we're doing and the momentum we've generated will only keep increasing following 2025. Our strategy in the back half of the decade is threefold. First, we're deepening and broadening our impact of diseases that we already know well, and we will keep going with these diseases until the unmet need is no more or science has hit its limit. For example, in psoriatic diseases and IBD, we're building on the successes with TREMFYA and creating an orally available IL-23 inhibitor that may significantly expand the number of autoimmune diseases -- autoimmune patients that can benefit from this mechanism. Second, we're developing more precise and targeted therapies. For example, we're building on our entry into the retinal space with AAV-RPGR with now multiple targeted therapies for additional inherited diseases, as well as common retinal diseases like geographic atrophy. Finally, we're expanding to new areas with new approaches where we believe we can be first or best and in disease areas that are supported by our scientists' insights. For example, we will expand nipocalimab from our current indications into additional rare and common diseases that have an autoantibody component. Likewise, we will build on our vaccine portfolio to create a first-in-class vaccine for deadly E coli blood infections. It's a really big deal. Together, these 3 strategies, along with licensing, acquisition and strategic partnerships, will help accelerate our momentum and productivity, driving over 65 potentially new transformational therapies in the second half of this decade. We credit our confidence to our highly tuned strategy and our differentiated engine, our team and our learning culture. Which now brings me to the how. Our end-to-end system of therapeutic areas optimizes every step of the product creation engine from the bench to the bedside and back without typical organizational boundaries. Having lived in a range of models, I'll tell you the virtuous cycle between bench and bedside drives incredible value in a truly unique way. Our TAs are themselves organized around disease area strongholds called DASs and pathway area strongholds called PASs. The DASs develop deep expertise around specific diseases, allowing us to optimize highly effective regimens and to execute expertly in clinical trials, and develop nuanced appreciation of workable regulatory and payer pathways. PASs on the other hand, allow us to follow the science boldly into whatever area of medicine a biological pathway takes us. A disciplined balance between DASs and PASs is actually key to our strategy. Our TAs work in close partnership with our world-class global functions. Our clinical trial engine is famous for its operational prowess. Our regulatory group shapes the environment in which we operate globally. Our manufacturing team drives tremendous value with both cost of goods and innovative product solutions. And our data science team is driving impact on so many of our programs and is central to our differentiation. We always want to have enough tools in the toolkit. This allows us to either -- use the right tool for the job. This is why we've invested in the PAS few years, with Rich's team, to develop internally or through key partnerships the expertise needed with different drug modalities, and we've done so in a disciplined and sophisticated way. This approach enables us to pursue the best medicines defined only by the biology and unmet need and unconstrained by modality or tool. And data science is critical. And we knew several years back that it would completely redefine how drugs are discovered and developed and changed the culture of innovation. Najat shared yesterday how in the last 18 months, we grew from an initiative with 5 or 6 programs to now a fully integrated global function used across 90% of our pipeline. Our strategy here is as follows. We've moved data science from an abstract notion to action with concrete high-value impact on our programs, making our programs move faster or with higher probability of health impact. We conduct test and learns to quickly see what works and scale successes. We've assembled and continue to grow a crack internal team of bilingual data scientists. These talented team members are proficient in data science and medical science, and work shoulder to shoulder with our scientists and physicians. And we are effective and discerning partners with the best companies in the entire data science ecosystem. We always start with a question here. We never lead with a technology. We've integrated this important practice across the entire discovery and development life cycle. A couple of examples to illustrate. We use AI ML modeling and built a biosignature platform to improve our success rate of molecular invention through images to infer biological activity. This provides fast cycle times and early warning systems that hasten molecular optimization. We're also generating better evidence preregistration. We're accelerating trials. We're improving patient identification. We're diagnosing diseases earlier and more accurately. And overall, we're increasing our probability of success. With our COVID-19 vaccine, for example, we built an award-winning model working with MIT to reduce trial size by 25%. We also ran a large and very sophisticated real-world evidence study showing that our vaccine has excellent durability. In PAH, we developed an ECG algorithm to detect the presence of pulmonary hypertension 12 to 18 months earlier than would have been detected otherwise and did so within 80% -- with 80% accuracy, allowing these patients to be on medicines that save their lives. And much, much more. We will continue to drive data science as a central differentiator. We partner differently, too, as Jennifer mentioned. Through Paul Stoffels' vision, we've deeply integrated ourselves within the biotechnology ecosystems around the world with our innovation centers, JLabs, equity investments through Corporate Venture Group, and a truly world-class business development organization. And we're not outside reaching in, but humbly sit inside this ecosystem. We're uniquely attuned to the needs of our partners. Myself having founded Theravance and served as their head of R&D and later helped create their Theravance Biopharma Innoviva, I know what it's like to be on the other side of the table from a large pharmaceutical company, and therefore always try to bring the mind of the entrepreneur and the specific objectives of the leadership and the investors of a partner company into the equation. In fact, earlier in my career before I was here, I admired Janssen among all pharma for cracking the code on partnerships. So this brings me now to our team where everything really starts and ends. Nothing is more important than a team that lives in an innovation culture of scientific curiosity and humility. These leaders are special, and we work together in true partnership and I'm proud of them. Our dedication to attracting and aggressively developing top talent in the world has been yielding results. You've seen the accelerating pipeline. We've doubled the financial value of our portfolio in the last 4 years. I'm especially happy with how we're increasing diverse representation at all management levels. I believe really strongly in a highly inclusive culture and a diverse team, and we've come a long way in this regard. So I've told you a lot, but no single factor I share today makes us unique. But rather, it's the sum of all these factors that generate the remarkable productivity, great momentum and an unprecedented delivery of life-changing medicines and vaccines. We are confident our R&D engine will drive impressive, steady, near- and long-term growth, and believe the transformational impact in store for patients over the next decade is unmatched. It's an honor to be here with you today. Thank you so much for your attention.

Ladies and gentlemen, we will now take a 15-minute break. Thank you. [ Break ]

Ladies and gentlemen, please welcome Global Therapeutic Area Head of Oncology, Peter Lebowitz; Vice President of Janssen Supply Chain, Remo Colarusso; and Company Group Chairman, North America Pharmaceuticals, Scott White.

Good morning, everyone. I'm pleased to share an update on our cross-functional approach to deliver a truly innovative CAR-T for the treatment of multiple myeloma. This is also Johnson & Johnson's first cell therapy and it will further strengthen our oncology leadership. So today, I'm joined by my friends, Remo Colarusso and Scott White. And in getting started, I'd like to share a bit of background about CARVYKTI, which will be the product name for Cilta-cel upon U.S. FDA approval. So our collaboration with Legend Biotech is an excellent example of our open innovation approach in oncology R&D. We identify innovation by following the data and evidence wherever it comes from, and we form partnerships where the sum is greater than the parts. So when we signed the deal with Legend, we were met with some questions and some skepticism because Legend was not a well-known company. But sometimes this is exactly where innovation happens. Through our diligence, we knew that the Legend team had discovered a potential best-in-class BCMA CAR-T that would further strengthen our mission of treating multiple myeloma. Once we signed the deal, as you see in the time line here, this collaborative team moved quickly. So in 2 years, we brought all the manufacturing of CAR-T to the U.S. We filed an IND. We initiated clinical studies. We completed an expansion cohort of U.S. patients and reported clinical data, and then we received our breakthrough therapy designation from the FDA. So now I'm proud that we are awaiting U.S. FDA approval. As I shared in yesterday's oncology strategy and pipeline presentation, we have seen unprecedented results with CARVYKTI in the treatment of patients with relapsed/refractory multiple myeloma with stringent complete response rates above 80%. We believe the design of CARVYKTI as a biparatopic binder differentiates this cell therapy from the other BCMA CAR-Ts. This likely contributes to the remarkable clinical profile demonstrated to date. Again, CARVYKTI has shown the highest level of activity of any multiple myeloma agent ever. There is no single or combination therapy that has demonstrated such results in multicenter Phase II or III studies. Our clinical development plan is also comprehensive. So early on, people wondered whether CAR-T could make it into frontline. And for us, this was never in doubt. It was always in our plan. And now CARVYKTI is in frontline multiple myeloma trial called CARTITUDE-5, and it's enrolling patients. CARVYKTI as a cell therapy brings inherent complexity in the manufacturing and supply chain process. And I'm pleased to introduce Remo Colarusso, who will share some of the innovations implemented in our supply chain.

Thank you very much, Peter. Good morning, everyone. Collaboration across all the functions enabled CMC enhancements to be put in place and really set the course for success. We partnered externally, learning every single step of the way and worked internally in an integrated end-to-end way, which resulted in the cell therapy product and process we are confident in. Now that we've built this integrated engine, we'll use it to power the next wave of innovation as we look to expand our autologous pipeline, move into the allogeneic space where we aim to expand and create new products to reach even more patients. In supply chain, we have gotten about upscaling manufacturing in this area in very different and innovative ways than in the past and in other therapy areas. We created a dedicated organization with a different, even more patient-focused structure and empower them to drive the progress forward. This enabled us to be more focused, agile and make quick decisions. Our approach has also been more integrated with supply chain engagement activities across the organization, beginning with R&D, running through clinical, commercial and many other functions. That collaboration has been consistent and ongoing as we move through the development process. We didn't hand off, but rather continued the cross-functional team to make sure we have the expertise and capabilities required at each and every stage, from concept to commercialization. All our work is powered by an end-to-end global digital ecosystem. The entire process is a single seamless experience powered by a comprehensive global order management, logistics and manufacturing digital ecosystem. We are streamlining hundreds of steps into a single user experience for the customer. Supply chain and technology are integrated to delivering this patient-centric, fundamentally different, make-to-order manufacturing and delivery process. This is not traditional supply and demand. We're using global tools to manage production capacity, planning and scheduling and tightly integrating them with manufacturing, which enables us to share product status to our front-end teams. We call these updates -- product status updates and mile manufacturing milestones. In addition, we have implemented cybersecurity controls throughout the entire digital ecosystem. We also relied on months of voice of customer research to differentiate what matters most to our customers. The systems that we have in place provide us with the connection so that we can deliver on our vein-to-vein supply chain and manage the needs of our patients. I'd now like to hand over to Scott White and -- who will share the insights of commercial preparation and approaches taken in terms of that vein-to-vein supply chain and meeting the needs of patients and physicians. Scott?

Thanks, Remo, and good morning, everyone. We believe CARVYKTI holds the promise to change the treatment paradigm in multiple myeloma. To deliver a high-quality product and experience requires a truly cross-functional effort with careful coordination and integration between all Janssen functions and with the treatment centers. Now our deep experience and expertise in hematology has allowed us to create unique and differentiating capabilities for this CAR-T technology. Additionally, we've established a constellation of patient care solutions that supports patient access, site training, proper cell handling and patient and caregiver support services, just to name a few items. We're also taking a very thoughtful and phased approach to our launch that is grounded and given the treatment centers, both the predictability and reliability they need to best manage patient care. It's important to remember that CARVYKTI treatment will be customized to the patient which means a given patient's own T cells are required for the manufacturing of the product. Now this requires a complex and well-orchestrated process for cell collection, cryopreservation, manufacturing and shipment and delivery back to the treatment centers. And to that end, we have integrated people, platforms and processes to create a reliable experience around CARVYKTI. We've also created on-site operational roles, along with an order fulfillment in-house team to ensure a high degree of communication and support for treatment centers and their patients. Of note, we've also developed a new digital management and workflow capability that creates a digital twin of each patient's extracted T cells and follows the live products with the entire system. The same system also helps to manage on-site activity and directs the appropriate commercial, supply chain and site support activities at the treatment center to support each and every patient. Now this is an exciting new technology that builds upon the core strengths of Janssen's R&D, supply chain and commercial capabilities. And leadership will require industry-leading coordination and integration across all of Janssen functions and [ with all ] the treatment centers. We're going to continue to work closely with the myeloma community and the treatment sites to support a successful launch for patients that are in need of this highly transformative therapy. Now in closing, I'd like to introduce you to [ Sean, ] who is a patient in our CARTITUDE-1 clinical trial. For [ Sean, ] CARVYKTI has given him a chance to think about the future again. And before [ Sean ] entered the CARTITUDE clinical study, he wouldn't allow himself to dream about a future. But now thanks to CARVYKTI, [ Sean ] is dreaming once again. And we know there's many more patients out there that are just like [ Sean. ] And that's why at Janssen, we are so committed to developing innovative products like CARVYKTI. Thanks for your time and attention. Next, I'm pleased to share that our innovations in oncology continue through our efforts to transform the treatment of lung cancer with RYBREVANT and lazertinib. Let's bring the team up. Thank you.

Ladies and gentlemen, please welcome Global Therapeutic Area Head of Oncology, Peter Lebowitz; Company Group Chairman, Global Commercial Strategy Organization, Vanessa Broadhurst; and Global Head, Discovery, Product Development and Supply, Rich Tillyer.

Okay. [Audio Gap] It's 2 major oncogenic driving pathways. So this is one drug, hits the tumor in 3 different ways. It blocks EGFR, it blocks MET and it activates the immune system through an enhanced Fc domain. RYBREVANT is the first targeted therapy approved for patients with non-small cell lung cancer with exon 20 mutations. And in my oncology pipeline presentation, I showed data in frontline and relapsed lung cancer with EGFR common mutations. These are the mutations that occur most often in patients with lung cancer. So I'd like to show you some different data here. So first, at the top of this slide, I'm showing data in EGFR exon 20 insertion patients. These data were part of our FDA approval. And as you see here with RYBREVANT, most patients have a reduction in the size of their cancer. The overall response rate here in this population by RECIST was 40%. In the lower graph, we see results from a completely different patient population. These are patients with lung cancer driven by MET exon 14 skip mutations, and these data were presented in September at World Lung. So as you can see, there is very impressive activity in this lung cancer that's driven by a completely different pathway. So the important point here is that because of the unique function of this antibody, the potential opportunity for RYBREVANT goes well beyond specific EGFR mutations and likely well beyond lung cancer. So I'm just going to show one more piece of data that I think is very important. And here, we treat patients with RYBREVANT in combination with lazertinib, which we licensed from Yuhan. Lazertinib is an oral, third-generation brain penetrant small molecule EGFR inhibitor. So with RYBREVANT and lazertinib combination, we believe that we have the ability to overcome resistance by hitting the tumor from all directions, targeting both the extracellular domains and the catalytic domains of EGFR. These are the early results from CHRYSALIS-2 study of the combination in patients with lung cancer with common EGFR mutations, whose disease has progressed after treatment with osimertinib and platinum chemotherapy. These patients have essentially already received nearly all approved therapies and their options for further treatment are very limited. And as you see here, the combination of RYBREVANT and lazertinib shows impressive activity in this highly pretreated patient population. So building on the promising results we've seen to date, we believe RYBREVANT has the potential to be the backbone therapy across all forms of EGFR and c-MET-driven lung cancer. We've already started our Phase III frontline EGFR trial evaluating RYBREVANT-lazertinib head-to-head versus Tagrisso, which is -- currently is the most effective standard of care in this setting. We'll also be initiating studies in MET-driven disease as well as studies outside of lung cancer, both colorectal cancer and hepatocellular carcinoma. So our clinical program is now rapidly expanding into these new opportunities. So now I'll take the opportunity to hand it over to Rich, who'll speak to the innovation for the molecule. Rich, over to you.

Thanks, Peter, and good morning, everyone. I'd like to build upon Peter's comments and just describe how we design RYBREVANT to deliver its activity, and how we partnered Janssen's science with external partners to create the first and potentially best-in-class product. So RYBREVANT is a highly optimized bispecific monoclonal antibody with excellent activity against EGFR-driven tumor cells via multiple mechanisms of action. RYBREVANT targets the extracellular domain of the EGFR receptor, binding [ 1 with type and ] all EGFR receptor mutations. It also finds MET, which becomes upregulated with EGFR inhibition and is a major evasion pathway for the tumor. The EGFR and MET-binding affinities were optimized to selectively target tumor cells over normal cells, binding results in tumor cell killing by disruption of signaling and by Fc-mediated macrophage-driven receptor degradation and phagocytosis. Combining the mechanisms of action of RYBREVANT with a novel third generation TKI lazertinib delivers a powerful multipronged attack on the tumor, delivering the results that Peter just shared. This program is yet another powerful example of Janssen's partnering strategy in which we combine internal and external science to deliver innovation to patients. After licensing the DuoBody platform and binders from Genmab, Janssen scientists invented and developed RYBREVANT. Accessing lazertinib from Yuhan allow us to create a combination regimen, and we're now advancing a subcutaneous formulation leveraging the Halozyme technology. Now building on our experience with RYBREVANT, we've assembled a powerful multi-specific protein therapeutic platform and a comprehensive pipeline. We're broadly applying the molecular design principles from this project and we've perfected DuoBody manufacturing. RYBREVANT is the first of many exciting molecules that you're going to see from our platform. Vanessa, over to you.

Thank you so much, Rich, and good morning, everyone. As you've heard from Peter and Rich, RYBREVANT has the potential to have a profound impact on the lives of patients. As the leading cause of cancer mortality worldwide, lung cancer accounts for approximately 1.8 million deaths per year, and that's more than breast cancer and colon cancer combined. Non-small cell lung cancer makes up 80% to 85% of all lung cancers. And within those patients, EGFR is the most common driver mutation with an incidence of about 20%. The 5-year survival rate for these patients with metastatic disease treated with TKIs is still less than 20% despite recent innovation. And it's this human toll that fuels our commitment at Janssen to improve the outcomes for patients diagnosed with lung cancer. And our vision in lung is focused on extending life through comprehensive treatment regimens. Our entry is developing RYBREVANT plus lazertinib into the standard of care for EGFR and MET-driven lung cancer. We are also developing RYBREVANT-lazertinib regimens in second line. And importantly, as Peter noted, we're going head-to-head in first-line versus market-leading Tagrisso. Today, it represents a $4 billion to $5 billion standard of care. We're focused on demonstrating superior efficacy, tolerability and offering patients a regimen that's convenient to use with plans underway, as Rich stated, to develop a subcutaneous formulation. The opportunity to build regimens beyond our current FDA-approved indication is considerable. In fact, we expect our eligible patient population to increase significantly over the 2021 to 2025 time frame. And our longer-term strategy will ultimately lead to significant growth potential in the multibillion-dollar range. And we aspire to make a difference for even more patients as we continue to investigate potential adjacencies with single agent or combination regimen approaches in lung cancer, and in other EGFR and MET-driven tumor types. Our commercial entry into lung cancer builds on our leading track record and the momentum of this transformational medical innovation. First, through demonstrated commercial and market access capabilities, we are building on our legacy of successful new transformational therapies in oncology. First in prostate, then in chronic lymphocytic leukemia and multiple myeloma and now in lung cancer. In fact, our oncology portfolio compound annual growth rate over 2015 to 2020 was greater than 20% and has outperformed the growth rate of the top 10 oncology companies. Second, we will be building on the U.S. launch that we had earlier this year. And the strong response from the medical and lung cancer patient communities can be seen in the headline clips related to the promising data presented for the RYBREVANT-lazertinib combination regimen at ASCO, ESMO and at World Lung. It's also important to underscore that the commitment to lung cancer extends to cross-sector approaches, where we are uniquely positioned to bring together opportunities through pharmaceuticals and medical devices, such as local drug delivery through the unique expertise of our Johnson & Johnson Lung Cancer Initiative. At Johnson & Johnson, we are uniquely positioned to harness science, expertise, and collaborations to combat lung cancer and reduce the impact of the world's leading cause of cancer mortality for patients like [ Keegan. ] So I hope you can sense our enthusiasm about our entry into lung cancer and the foundational combination regimen of RYBREVANT and lazertinib, and we look forward to taking your questions in our Q&A panel coming up next. Thank you.

Ladies and gentlemen, please welcome our therapeutic area Q&A panel. From Investor Relations, Jen McIntyre. Company Group Chairman and Global Commercial Strategy Organization, Vanessa Broadhurst; Global Therapeutic Area Head, Vaccines, Penny Heaton; Global Therapeutic Area Head, Oncology; Peter Lebowitz; Global Therapeutic Area Head, infectious diseases, James Merson; and Company Group Chairman, North America Pharmaceuticals, Scott White.

Great. Hi, everyone. I'm genuinely thrilled to be here with you today and to be moderating the question-and-answer portion of today's event. Just a couple of logistical items before we dive right into your questions. First, as a reminder on the agenda, there are 2 therapeutic area Q&A panels, and then a wrap-up enterprise-related lunch with members of our EC, who'll take questions that you have related to the enterprise. So as a result, as you sit here and ask questions, please try to gear them towards the leaders at the table at the time and the spaces that they support. [Operator Instructions] So with that, I'll take the first question from the room. Louise?

So there are many potential new treatment modalities for multiple myeloma -- and how do you think about where your therapeutics fit into this treatment paradigm, evolving treatment paradigm? And how do you think doctors will choose between all these different options?

Yes. So excellent question, and it's an important one at this time in multiple myeloma. So I want to go through this, but it requires understanding where the field is and understanding where the field is going. So the first really important point is that multiple myeloma is still an incurable disease. So despite the advances that we've made, despite all the therapies that are available, patients diagnosed with multiple myeloma today with the available therapies have a fatal disease. We hope to change that, right? So as you point out, Janssen has 4 major potential therapeutics in multiple myeloma with DARZALEX, our 2 CD3 redirectors, and our CAR-T. What we need to do is we need to change from going from a paradigm of treating to progression, which we do now, we treat and then the disease progresses and then we move to the next therapy, to a paradigm of treating to cure. And what that means is you need to start putting these therapies together. So the ultimate regimen of the future that we are beginning to build is a regimen where we have an induction regimen -- induction piece that probably includes DARZALEX and a CD3 redirector, Patients then, instead of going to transplant, they go to CAR-T which will eliminate most of their disease, and then there's a consolidation phase where you have another regimen that contains potentially another CD3 redirector, DARZALEX and perhaps one more agent. And that's the paradigm that we believe that will define the future of multiple myeloma. And we're in a very good place to actually form that future.

Great. Thanks, Louise. Chris?

Chris Schott at JPMorgan. So just following up on that. I think you talked today about in your late-stage pipeline, a $5 billion asset in myeloma. I think in the presentation yesterday, there was the bispecifics said $4 billion each. Do I think about that revenue as kind of incremental to the oncology portfolio? Or at some point, do we start to think about DARZALEX's role maybe being shorter duration or curtailed in some way? I'm just trying to get a sense of, like I was thinking about the portfolio as a whole? Like how much of that is incremental versus starting to cannibalize a bit? And if I just can slip a second quick one in there. Capacity on Cilta-cel, can you just talk a little bit about how you avoid some of the challenges that your peers seem to be having of getting this ramped up as it launches?

Sure. Thanks, Chris. I'll start with your first question first. So when we look at DARZALEX, DARZALEX has been just an incredible growth asset for us. You saw from the presentation this morning and the night before just a remarkable asset. That's because of the aggressive clinical development plan we've had. That plan continues. Right now, DARZALEX has 3 frontline indications. We're looking at 2 additional frontline indications in quad. And that's going to give us more opportunities for both to transplant-eligible and transplant-ineligible population. So we see DARZALEX continue to move earlier. Additionally, we're doing an aggressive study right now in smoldering myeloma. And that's going to give us some new insights for this very early disease population that DARZALEX can go into. Additionally, we -- as Peter mentioned, we're building regimens as well. And DARZALEX will also be part of those regimens. And so when we look at DARZALEX, we feel confident about the product's future. And we would see this as another -- these other assets as incremental growth to the business. On your second question on -- can you repeat that again, please?

It was really just a question about capacity and how do you avoid some of the challenges that at least some of the initial CAR-Ts seem to be running into in terms of supplying demand in the market?

Sure. I'll start with the commercial launch and Peter, if you want to jump in on some of the other items. But when we look at the commercial launch, as I mentioned in my presentation, we're taking a very thoughtful and phased approach, and that was done at day 1, recognizing the feedback that exists within the marketplace. The thing that our customers really want the treatment segment site specifically was have a predictable and reliable system so that when they slot a patient in, for lack of a better term, that they can know when that patient is going to receive their medicine, and it's something they can see reliably time and time and time again. And that's why we've invested heavily not just in our supply chain capabilities, but also those commercial capabilities, especially the digital technology as well as all the other support staff to provide that predictability and reliability. And so like you said, we're having a phased approach, we're going to launch, and then we're going to quickly continue to ramp up as well as making sure that we have those early experiences are informing the mid- and later experiences with the product. So we're excited about what this means. We're confident we're taking the right approach, and we're really taking a very patient-centric approach to this launch.

Peter, anything you want to add?

The only other thing to add is the supply chain team is doing everything they can to make sure that we get the best launch possible. And one of the things that they've done, which is an advantage is to begin to secure that lentivirus supply that we would control ourselves. So...

Great. Thanks, Chris. Matt?

Matt Miksic from Credit Suisse. So I had a question on Peter, maybe if you could describe some of the opportunities that you see for collaborative or synergies related to drugs and devices. It's a question, obviously, that's come up a lot in the last week or 2, but terrific to hear how you see those 2 businesses and opportunities working together in the therapeutic areas.

Yes. No, it's an important area for us and one in which I think we're making actually early progress that will only accelerate. And I think there are 2 major efforts to draw to your attention. One of them is the lung cancer initiative, where we're looking at both device and drug in a way that we can address the disease, particularly the early diagnosed disease in different ways than it's being addressed right now. And that's completely new technologies coming into place and drugs and technology coming together. The second one is the TARIS platform, and we did an acquisition of the company, TARIS, because we wanted to really have an impact in localized bladder cancer. And here, we have drug device. These are already in Phase III trials, but this concept of actually getting a drug locally in a consistent and high concentration way, we think, is going to have a big impact there. So these 2 efforts show you that it can be done and it can be done successfully, and there are other areas that are ripe for combining drugs and devices.

Great. Thanks, Matt. Lisa, can we take a question from the platform?

Yes. Moving to another area. Do you think the success in hepatitis C will be replicated in hep B? And how close are you to a cure?

This is a good question. As you know, treatments for hepatitis C were incredibly successful in respect that they were able to cure that disease quite unexpectedly actually within 8 weeks of treatment. HPV though is a chronic disease. It's quite different, and that's because the viral genome integrates itself into the human chromosomes. And what this means is that this virus, when it's replicating unless it's inhibited by nucleosides, continues to express viral proteins which are highly immunosuppressive. And they prevent the host immune system from controlling this infection. And if it's not controlled, then you develop cirrhosis and then go on to liver carcinoma. With regard to functional cure, which is defined as the inability to detect either HPV DNA or HPV surface antigen, which is the immunosuppressive protein produced by the virus, we need to manage the immune response such that we can reactivate it so it can take control of the infection. And what this really means is that T cells are required to remove infected hepatocytes. And so right now, what we are looking to do is to utilize our sRNA, JNJ-3989, which is a really potent molecule for not only preventing viral replication. But importantly -- and this is the first molecule to demonstrate profound reduction of HBs antigen. This is highly immunosuppressive. With that taken out of the picture, what we expect to now be able to do is create an environment where the immune system can now regain control. And so we've just completed our REEF-1 IIb study, which was a study looking at our sRNA plus our capsid assembly modulator as well as the nucleoside analog. And what we found indeed was profound reduction of HBs antigen. What we didn't see though was the high rate of functional cure that we were hoping for. And what this tells us is an antiviral treatment alone is insufficient to allow the immune response to take control. So what we're now utilizing is other immune modulators in our portfolio, whether they be an innate immune system activator, a means for generating HPV-specific T cells or a means for keeping those T cells active when they meet the virus. And so we have ongoing studies right now with our cornerstone sRNA in combination with immunomodulators and those studies are ongoing. So whether we'll be able to get those high functional rates remains to be determined. But as I say, those studies are ongoing, and we look forward to the future to see how they pan out.

And Jen, maybe I can just add that one of the reasons we're so excited about hepatitis B is that although much progress has been made in hepatitis C, there are still 300 million patients who are impacted around the world by hepatitis B today. So as we aspire to get functional cures and control of the disease, there are many patients out there definitely waiting for more treatments.

Thanks, Vanessa. We'll take another one in the room. Joanne?

Joanne Wuensch from Citibank. I wanted to ask about the RSV vaccine and how large of a market opportunity you see that to be? And how do you see it sort of shaking out competitively versus other products, which may or may not be on the market.

Yes. Penny, do you want to start?

Sure. So thank you for the question. So RSV causes 64 million cases every year globally, 33 million in children. We don't -- sometimes -- we don't recognize it as often as influenza or COVID, but it is a leading cause of lower respiratory tract disease, pneumonia, bronchiolitis. And it affects people at extremes of age. It affects infants and young children, and it affects older adults. In the U.S., that translates to 177,000 hospitalizations every year and 14,000 deaths. We've been working on an RSV vaccine, the global ecosystem, public health ecosystem. We've been working on RSV vaccine since the early 1960s. And success has been really elusive until now. Our CYPRESS Phase IIb study was one of the first large studies actually to show clinical protection of an RSV vaccine. We had 80% protection against lower respiratory tract disease in older adults. So with those data, we have now moved into the Phase III program and are looking forward to having those results confirmed and filing next year. So now, Vanessa, I'll turn it over to you for the...

Yes. So maybe I can just speak briefly to the competitiveness. And we do realize it's a competitive space, but I think we are up for it. We have a demonstrated track record of launching first and small molecules, then we launched into biologics. You heard from Scott and Peter around the launch preparations for the CAR-Ts. And we see vaccine as a next area that we are prepared to aggressively compete and win in. So I think we're ready to go and very excited to see the progress made by our R&D team with the dynamic CYPRESS results. So...

Great. Is there another question in the room? Matthew?

Matthew Harrison, Morgan Stanley. If we can go back to myeloma for a second. I was curious on your response to how you're thinking about curative approaches for myeloma. I mean obviously, with CD19 CARs, we've seen CRs be very durable. Even in the late-line setting, you haven't seen that with the BCMA CARs. So I'm wondering what you think is different as we move in earlier lines, if you think you can see durability from those CRs or you need additional treatments. And then if I can sneak a related question in just on the push out of the PDUFA. Can you just comment on your confidence around the potency assay and that, that won't be an issue in meeting the new PDUFA?

Yes. No, those are excellent questions. And starting with the first one, the -- in general, as the cancer progresses, it gets more complex and more difficult to treat. So these very late-stage multiple myeloma cells have a lot of resistance mechanisms. They've seen a lot of therapies, and they are harder to treat. Even with that, by the way, the progression-free survival with CARVYKTI is -- in that population is well beyond anything that anyone has ever seen, right? It's over 21 months, and it will probably as the data matures get even longer. So what we expect is in the early setting that we will have more durability. But more importantly, as you reduce the tumor burden with an induction regimen and then coming with CAR-T and then have a consolidation, that's where we think we get to really long-duration remissions and potentially cures, right? So that's what we believe will happen. Regarding the PDUFA date, we don't see this as a major risk. We've submitted material to the FDA. They felt they needed more time to review it. They're going to have their more time to review it. But this new PDUFA date, we feel pretty confident with.

Great. Thank you, Matthew. Lisa, can we take another question from the platform?

Yes. So on EGFR lung cancer development in China, how much of a threat are the innovative drugs that may enter developed markets at a significant discount? And what does that do as far as disruption to your potential pipeline of drugs in this area?

Do you want to take the...

I can, yes. So listen, when we develop our drugs, I think one of the very special things about Janssen is we work early and very effectively in terms of looking at the value of our products. And we don't just look in the European and U.S. markets. We work together worldwide to make sure that we are demonstrating value and looking to gain equitable access everywhere. So as we look towards China, we know that there is a significant opportunity for lung cancer in China as well as the rest of the world. So we are effectively working with the health authorities and regulators in China, and we continue to move forward in developing our asset to launch in that region. In terms of competitors, we are -- China is continuing to develop, and its payer system is continuing to develop, but we have been quite successful in securing our products both in the private market as well as the NRDL. And we look forward to continuing to advance access to our medicines in China through both of those areas.

Great. Lisa, is there one more from the platform?

So on bladder cancer, can you discuss the competitive landscape, PD-1s and other mechanisms?

Yes. So PD-1s have clearly shown activity in bladder cancer, and there are a number of trials with PD-1 plus BCG. What we are doing is actually creating all new regimens. So we have our own PD-1s, cetrelimab that we've taken into the clinic to combine with TAR-200. And our view is that this new technology, which is delivering local drug to the bladder with a systemic immuno-oncology approach, is going to be a regimen that will take on a number of stages in bladder cancer. Our trials are going into frontline versus BCG as well as in muscle invasive bladder cancer going against chemoradiation. And these are the current standards of care. So PD-1s will have a role and they'll be included in the regimens that we develop.

Great. Larry?

Larry Biegelsen, Wells Fargo. One, just for Penny, on the COVID-19 vaccine, how are you thinking about the sustainability of the revenue there? It's not on the list of $1 billion products. When will you have a sense of kind of what the outlook is beyond 2021? And then...

Yes. So I'll talk a little bit about the clinical development and then turn it over to Vanessa to comment on the longer-range forecast. So we believe that our COVID vaccine is a really important tool for addressing the pandemic. I mean clearly, COVID is still affecting people in every corner of the globe. The economic impact has been tremendous, schools closed, travel cut short. It's happening again. Am I going to be able to go delight to see my team in 2 weeks or not? So the impact is enormous. And we have good data. We've just recently released on our booster study. The single dose has provided long-lasting durable protection. And then when you add that booster at least 2 to 6 months after that single dose, you get even a higher level of protection, 94% in the U.S. against any symptomatic disease and 100% against severe disease. So we feel really great about the results of this vaccine and the potential impact that it can have on the pandemic. So with that, I'll turn it over to Vanessa for the...

Thanks, Larry, for the question. So we have -- we are confident that we will deliver about 1 billion doses in 2022, and we will give guidance as usual in January in terms of sales.

Okay. Do we maybe have one more question in the room? Danielle.

So just a quick question on lung cancer. And one of the tenets of J&J is cross -- working across the different business units. Just curious about how you guys on the pharma side have been working on the medical device side with Auris Health and sort of what to expect from any sort of potential partnership there over the next few years.

Thanks for that question. So the answer is we've been actively working together around the lung cancer initiative. I think -- and one of the big advantages we have is the technology is a technology that can do things that other technologies are not able to do, which allows us to take on the potential of injecting tumors in different ways with different mechanisms of action. So you'll be seeing more of that as time goes, but we have many plans in progress to combine innovative drugs with device in lung cancer. And the major idea there is that if we can inject to tumor locally, we want to be able to generate a systemic immune response from that injection. And thereby, you get actually not just the local effect of injecting and potentially ablating a tumor, you also get a potential response to prevent that tumor from coming back metastasizing.

And just to be really specific, that lung cancer initiative is the Auris technology being used in trying to address lung cancer.

Yes. Thanks, Danielle, for your question. That's all we have time for right now. I want to thank all of you for your thoughtful questions and for the panelists for your thoughtful responses.

Thank you.

Thank you. [Presentation]

Ladies and gentlemen, please welcome Global Therapeutic Area, Head of Immunology, David Lee; Worldwide Vice President, Immunology, Teri Lawver; and Global Therapeutic Head, Neuroscience, Bill Martin.

Good morning. I'm David Lee. And I'm here with my colleagues to share what Janssen is doing to transform care for those who like Robert, Jeremy or Bethany and Lucy, suffer with autoantibody-driven disease that occurs when self-attacking antibodies turn on the body. Joining me are Terry Lawver and Bill Martin. In October 2020, we completed the acquisition of Momenta Pharmaceuticals, marking our entry into autoantibody-driven disease. Today, we'll share the unmet need that exists in diseases driven by this pathway; the science behind the lead asset, nipocalimab; and our strategy for delivering the full potential of this pipeline in a pathway.

Our approach to nipocalimab and autoantibody-driven disease illustrates the power of our pathway-centric development strategy. With this approach, we identify diseases driven by a common immune pathway and then pursue novel therapeutics that can differentially modulate that pathway, enabling us to impact many diseases with a single therapy, building a pipeline and an asset. Collectively, there are more than 70 autoantibody-driven diseases impacting nearly 200 million patients worldwide or 2.5% of the population. With nipocalimab, a potentially best-in-class FcRn inhibitor, we've systematically assessed the spectrum of autoantibody-driven diseases, prioritizing 11 with the highest unmet medical need and actionability. And we're off to a fast start with parallel clinical programs across indications, ranging from larger familiar diseases and specialties where Janssen has a leading presence to rare orphan indications. For example, one of the new spaces we're entering is maternal fetal disorders, such as hemolytic disease of the fetus and newborn, the condition that so tragically impacted Bethany and causes fetal anemia. This condition thankfully is rare, affecting about 14,000 pregnant women annually in the G8. Today, the only treatment option is intrauterine blood transfusion, a highly invasive procedure with a 15% risk of fetal demise. And then their Sjogren's syndrome, which disproportionately impacts women of child-bearing age and is characterized by severe fatigue and debilitating organ dysfunctions. Today, there are no approved advanced treatments for Sjogren's. Now pioneering new treatments for areas of such high unmet need creates meaningful growth potential. While we don't share product-specific forecasts, I can put the magnitude of opportunity into perspective. Across the 11 prioritized disease areas, we see an addressable population of 2.1 million in the G8 alone. As a point of comparison, the addressable market for advanced immunology therapies in inflammatory bowel disease, Crohn's disease and ulcerative colitis, is also about 2 million patients in the G8, and this was a $19 billion market in 2020. Given the unmet need and the size of addressable patient population, we see the potential for nipocalimab to deliver billions in annual revenue.

Now let's take a look at the science of autoantibody-driven disease. An autoantibody is an antibody that attacks individual's own tissues. The neonatal Fc receptor also called FcRn serves 2 functions. To naturally regulate the level of antibodies in the body. After birth, FcRn rescues antibodies from the degradation pathway by pulling them out and recycling them back into the body. During pregnancy, FcRn pulls antibodies from the mother's circulation to the fetal circulation. Nipocalimab targets the antibody binding site of FcRn and, therefore, rapidly lowers antibodies, including autoantibodies before and after birth. Importantly, our research confirms that nipocalimab drives a potent and dose-dependent decrease in circulating antibodies, and its ability to lower IgG appears quite strong relative to competitors. Now on to our development strategy. We're focused on 2 large categories of disease, definitive and complex. The autoantibody pathway is the thread that connects them. So definitive diseases have a clearly defined autoantibody that causes diseases by a singular mechanism. These are typically orphan disorders with examples that include the anti-acetylcholine receptor antibodies and myasthenia gravis or the anti-arithrocite antibodies in adult or fetal hemolytic anemias. Rare diseases share specialized development approaches, and pursuing parallel indications provide synergy. Now complex autoantibody diseases are defined by the presence of multiple autoantibody specificities, which implicate other pathways in disease. These are often subpopulations of prevalent diseases such as rheumatoid arthritis or lupus. Here, our development strategy will be guided by stratifying patients and based on quantifying autoantibody pathway activities. It's clear from our research that nipocalimab can produce deep reduction of autoantibodies, affording flexibility for dose and reduction of each disease. And that's going to give us the ability to dose differentiate. So here's a look at our initial development plan, which we are executing in parallel. The scope and degree of complexity aligns well with the depth and breadth of Janssen capabilities. We anticipate being very competitive, and we're reaching for first-in-class market entry across indications. Next, let's hear from Bill and the need in neuroimmunology.

Thank you, David. Our lead program is in myasthenia gravis, or MG, a condition, as you heard from Robert, that brings drooping eyelids, muscle weakness and importantly, respiratory distress that can lead to hospitalization. Current therapies have many limitations. And we hear from health care professionals and patients alike about the critical need for new options. Nipocalimab combats MG by reducing autoantibodies directed against acetycholine receptors, reestablishing chemical transmission in the neuromuscular junction and restoring normal muscle contractions. Here's a snapshot of our Phase II results, which evaluated activities of daily living within the first 2 weeks of treatment. Results showed a rapid, sustained and predictable clinical response with nipocalimab over placebo, and nipocalimab was generally well tolerated. The rapid onset of actions seen in this Phase II study is promising and will be evaluated further in our ongoing Phase III study. Let me close by sharing that last month, nipocalimab received its fourth orphan drug designation from the FDA for the treatment of chronic inflammatory demyelinating polyneuropathy, another neurological -- neuroimmunological condition with high unmet need. We look forward to initiating those Phase III trials next year.

Unlocking this asset's full potential requires industry-leading end-to-end capabilities. It starts with deep scientific and patient insights and proceeds with innovative study designs, evaluating the potential for multiple formulations and generating data to support approvals worldwide with day 1 market access. The nipocalimab program is Johnson & Johnson at its best, from bench to bedside.

So let me close by underscoring our commitment to transform care for the millions of people living with autoantibody-driven disease. Today, we've outlined our ambitious development strategy, and we are just getting started. We're already evaluating next-generation programs and assets that will build on this foundation. Our talent will set us apart. The combined expertise of scientists from Janssen and Momenta is powerful. So as we look ahead, we are simply intent on helping every Bethany and Lucy, every Robert, every Jeremy, every Cynthia that we can. Thank you.

Ladies and gentlemen, please welcome Global Therapeutic Area Head, Cardiovascular Metabolism and Retina, James List; Company Group Chairman, Global Commercial Strategy Organization, Vanessa Broadhurst; and Chief Data Science Officer and Global Head of R&D, Strategy and Operations, Najat Khan.

Hello, everyone. We are here to share how we're doing things differently to make transformational medicines that preserve and restore vision and prevent blindness. Retinal disease is an area ripe for innovation. While the VEGF inhibitors have helped countless patients for more than a decade, our understanding of the biology of retinal disease has come a long way and there are a lot of promising new targets. There's unmistakable unmet need in retinal disease, diseases like X-linked retinitis pigmentosa, geographic atrophy, achromatopsia are extremely devastating and there are no approved therapies. Can you imagine what these patients experience as the world they see gradually fades away? Here's a sense of how it might look through their eyes. People with X-linked retinitis pigmentosa, or XLRP, have progressive vision loss starting in childhood with night blindness. Then over time, it was a peripheral vision, getting tunnel vision and then total blindness by the time they're middle-aged. Now here is someone with achromatopsia where there's visual impairment from birth. Patients have painful light sensitivity. They're unable to see in daylight. And even in dim light, they have poor visible acuity and no color vision. And with geographic atrophy, which is a common advanced phase of age-related macular degeneration, people lose patches of vision, which causes a blur or a blind spot typically right in the center of the field of vision. Now since we were last together, we've built a really promising pipeline. On top of our gene therapy assets for monogenic disease, we've got an exciting clinical stage asset for common retinal disease with our Exonate collaboration to develop an eye drop designed to replace VEGF inhibitors in diabetic eye disease and wet AMD. We also acquired an investigational onetime outpatient gene therapy for geographic atrophy, the most common cause of blindness over the age of 50. Now there are a lot of advantages to using gene therapy in the eye. It's a small, contained, immuno-privileged space where we can use relatively small amounts of vector and a onetime treatment. We're especially excited about our investigational gene therapy for XLRP, which is designed to counteract the loss of retinal cells resulting from RPGR mutations. With our interim 1-year data, we're seeing significant improvements in retinal sensitivity, visual function and functional vision. And that sets a stage for Phase III, which is now actively screening patients. Now key capability in developing any rare disease treatment is connecting with patients, and every advantage here counts. We work with advocacy groups, major eye centers, prominent retinal specialists to really understand patient needs and preferences. We also connect to patients through data science, where we're doing things differently. And here to talk more about that is Janssen R&D's Chief Data Science Officer. Najat?

Thank you, Jim. Data science is a key differentiator for us at Janssen. In this highly competitive retinal space, data science is transforming how we build innovative therapies for patients across all phases of our portfolio. Let me share a few concrete examples of impact that we are having. Identifying patients for any trial can be difficult. But with rare diseases with genetic mutations like RPGR, it creates a whole new set of challenges. In addition, being the first to market is critical for gene therapy, such as RPGR. Therefore, speed is of the essence. To solve for this, we're leveraging sophisticated data science analytics to enhance how we find define eligible patients and optimal sites for our clinical trials. With RPGR, our data scientists mine multiple global real-world data sources and build a sophisticated machine learning model to identify clinical study sites with eligible RPGR patients to accelerate our Phase III enrollment. And the results are compelling. To accelerate our ongoing trial, the sites were recommended -- that were recommended by our machine learning models are, in fact, the top enrolling sites today across the world. Given the clear impact of data science on this program as well as several others, we are now scaling this approach across our pipeline. Another challenge in the retinal disease space is the use of traditional end points for our trials, which tend to be subjective and noisy. To address this, we are developing more quantitative image-based biomarkers and end points using AI and machine learning techniques applied both to large-scale real-world data as well as historical clinical trial data. We're making tremendous progress in chronic diseases, such as geographic atrophy, and diabetic macular edema, where novel-based image biomarkers are allowing us to improve our patient stratification to target the right therapies for the right patients, ultimately driving significant impact. As we build our retinal pipeline, it becomes very important to generate high-quality evidence to inform our key decisions both on internal assets and external assets. An example of this is during our diligence of our investigational gene therapy asset for geographic atrophy. We developed a high-quality external control arm to assess the potential therapeutic benefit for this asset. This data science-driven evidence generation was central to our ultimate decision to acquire the investigational gene therapy asset. Beyond retinal, we have created tremendous value using data science and digital health across our portfolio. We have more than 100 data science projects underway, all with a singular focus to develop better medicines for our patients. With that, I'll hand it to Vanessa to highlight our key commercial capabilities.

Thanks so much, Najat. So taking a global view and with a commercial lens, our go-to-market approach in inherited retinal disease is much like our CAR-T launch in multiple myeloma that Scott discussed earlier. But here, we're matching medical innovations in gene therapy with significant unmet need where 350 million people globally are living with undertreated or untreated retinal disorders. And the consequences of those disorders are substantial. Severe visual impairment and blindness plays a massive burden on patients, their families and health care systems with a significant cost burden. Our commercial entry into retinal disease requires a close partnership between all of our functions, including supply chain, commercial, medical affairs and IT. But really, the process starts and ends with the patient. So we've been working on several critical areas such as increasing advocacy for genetic testing to accurately identify patients. And education, access and support to meet the informational and logistical needs for the procedure. This outside-in approach really lets us deeply understand the disease, and how it's treated. One of the core strengths of Janssen is learning agility, and we have a strong history of launching increasingly complex pharmaceuticals and biologics versus small molecules and monoclonal antibodies. We've managed frozen material supply, distributed complex therapeutics. And now we're prepared to enter the personalized medicine space with RYBREVANT, our CAR-T and with gene therapy. Our retina portfolio has deepened, and we're rapidly advancing our go-to-market plans through patient insights and continued innovation to meet our patients' needs. And we hope you're as excited as we are, and we look forward to taking your questions in just a few moments. Thank you.

Ladies and gentlemen, please welcome our therapeutic area Q&A panel from Investor Relations, Jen McIntyre; Company Group Chairman, Global Commercial Strategy Organization, Vanessa Broadhurst; Global Therapeutic Area Head, Pulmonary, Hypertension, Neil Davie; Global Therapeutic Area Head, Immunology, David Lee; Global Therapeutic Area Head, Cardiovascular, Metabolism and Retina, James List; Global Therapeutic Area Head, Neuroscience, Bill Martin; and Company Group Chairman, North America Pharmaceuticals, Scott White.

Great. We look forward to answering more of your questions. Very quickly before we dive in, just a reminder, if you're in the room and would like to ask the question simply raise your hand. State your name and the firm you represent and use the push-to-talk microphone. [Operator Instructions] So with that, I'll take the first question in the room. Matthew?

Great. Matthew Harrison, Morgan Stanley. I was curious on the retina pipeline. You obviously emphasized gene therapy. With a lot of the retina gene therapies, we've seen inflammation be a significant issue, especially on intravitreal gene therapy. So I'm wondering how you can talk about how you're managing that and if you see that as a risk to the pipeline.

Certainly, inflammation is one of the side effects that you have to very carefully monitor in gene therapy in the eye. Gene therapy associated uveitis is something that can not only lead to problems in the eyes but it can also decrease the efficacy of the gene therapy. So this is something that we monitor very closely. And I think this comes back to sort of the early days when I was learning drug development where one of the sayings is the hardest thing is to get the dose right. I think in gene therapy, getting the dose right is key. You have to have the right capsids. You have to have the right preventive strategy using steroids in the right way, but it's really getting the dose right and making sure that with that right dose, you're bringing lots of long-lasting benefits to the patients for the risk of what is hopefully some temporary inflammation in some of the patients. So we're watching this very carefully.

Great. Thanks, Matthew. Any other questions in the room? Larry?

Larry Biegelsen, Wells Fargo. One nipocalimab and one on the pulmonary hypertension franchise. So nipocalimab, I think David yesterday, you talked about limited lipid changes. Can you be more specific and if they're clinically meaningful? And on pulmonary hypertension, it's probably the numbers you gave suggested over, I think, $5 billion in sales in 2025. It's probably the biggest disconnect from our model that we saw yesterday from the slide. So what's driving that from about $3 billion in 2020 to over $5 billion in 2025 and your confidence in that?

Yes, maybe I'll take the first question on nipocalimab. So we, of course, look very carefully at our data sets thus far. And what we observe is that the -- and what we mean by limited impact on lipid profile is that we don't see meaningful impact at the doses that we need to achieve. So the substantial IgG reduction and achieve maximal efficacy. So we're very enthusiastic and optimistic about our path forward with that molecule. Of course, we're going to continue to follow that very closely as we develop the molecule. But as of now, there's been no limitation of where we take and what doses we're using.

And I start with pulmonary hypertension -- thank you for the question on pulmonary hypertension. Just to start to refresh everyone, we're talking here of a very progressive fatal condition. And despite available therapies, there's still a high unmet medical need. So we have a very robust portfolio and pipeline where we're maximizing the current assets we have, both for OPSUMIT and UPTRAVI. And we're also extending those into new formulations, new dose strengths and to new patient populations. So we're very confident we can drive growth over the next few years and really create patient value for people living with different forms of pulmonary hypertension.

And just to add to that, one of the things that we do have is the strength of our existing portfolio. So if you look at OPSUMIT with 17% growth, UPTRAVI with 19% growth on a worldwide basis, both these products are blockbusters today. And this is exceptionally strong growth even considering that we're still in the COVID period. So as we look forward, these products will continue to drive against this large unmet medical need that exists in pulmonary hypertension. Additionally, we have really strong long-term follow-up data for both products, which continues to demonstrate exceptional overall survival results. And that's what's really driving the penetration right now and the growth of the assets. We see that continuing in the future.

And I would just reemphasize what Neil said about us going into different patient populations. So we have the fixed-dose combination in the pipeline. We have Maci-75, which I know Neil discussed which we're studying in both PAH and CTEPH. So we have the opportunity to not just advance therapies -- advance care with the therapies that we have on market by both getting patients diagnosed earlier and then expanding to triple therapy. We also have new innovation coming in the pipeline that will spur growth.

Thanks for your questions, Larry. Lisa, can you take one from the platform?

Sure. Initial Phase II data with nipocalimab suggests that 30-milligram and 60-milligram IV are associated with this IgG reduction. Can you develop a nipocalimab subcu formulation that can deliver similar doses of a single injection? And do you envision that subcu formulation will be infusional? And just discuss your subcu development plans.

Sure. Maybe I'll start and Bill can also comment. So one of the attractive features of nipocalimab is our ability to deeply reduce IgG via this natural mechanism. However, in our development programs and in our development programs, we also know that you don't actually have to go that deep to achieve maximal efficacy. And so this is a very focused development plan where we can index on a highly quantifiable measure circulating antibodies and understand what we -- how we lower to just what we need. So we're driving that forward in our multiple dose study in myasthenia, and Bill can maybe speak more to that. Vis-a-vis subcutaneous development, we are actively progressing development of a subcutaneous formulation. The initial bioavailability studies are coming in now. Stay tuned for where that lands, but we're very optimistic that we'll have a very patient attractive and friendly -- patient-friendly device that allows subcu administration where it's needed and valued.

I think that covers it.

Great. Another question in the room? Louise?

Louise Chen from Cantor. So curious how you think about the competitive landscape for anti-FcRns? And what do you think about the durability or how the durability -- how lasting will it be for these products?

Yes. So again, maybe I'll take the first stab and ask my colleagues to join. So we are used to competition and there is competition in the FcRn space, no question. We are extremely enthusiastic about nipocalimab based on several features. I'll start with what I said earlier. It has the most defined ability to naturally lower antibodies amongst competitors. That's a great starting point. There's also how we will be -- the design of the molecule itself has a number of attractive features over other competitors. I'll just name one. Well, first of all, it's a fully human IgG1 antibody, has been engineered to the Fc domain as silent and you really want that silent Fc domain because where it exerts its mechanism of action, there's actually activating Fc receptors. So for others that don't have that, there's an inflammatory potential that nipocalimab avoids. And then there's -- we're already developing in pregnant women. That's a huge differential from where others are. You saw in the video that it's just the tip of the iceberg of the unmet need in that space. And we're very proud to be in the lead there, and we're going to be in the lead in a number of other places. So both -- how we're developing the molecule, the attributes of the molecule itself, we're very enthusiastic about where we stand amongst competition.

So I'll just add to that. And listen, we don't take the competition lightly, but I do think we have reasons to believe that we will be successful. And the first one is that this really can be a pipeline and a product. As we said, we have over 10 indications in development. And most of those -- we anticipate to be first to market, most of those. We also have experience here. We have the experience of REMICADE, and we've demonstrated our ability to do this and take a product and sequence multiple indications and build to a very large overall asset. So -- whereas we don't take the competition lightly, I believe that we are really justified and prepared in our ability to drive commercial success with nipocalimab, and it represents a very exciting asset in our portfolio.

Great. Another question from the room. Maybe Joanne?

Joanne Wuensch from Citibank. A question on Vision Care. It always seemed to make sense to me to marry some of the pharmaceutical efforts with the medical device efforts. And you alluded to that on last week's spin call. Could you maybe give us a little bit more granular on how you're working towards that, either in product development or simplistically and marketing to the ophthalmology population?

Sure. Perhaps I can start and then maybe Vanessa take it from there. I think it's important to understand that in the pharmaceutical sector, we're working in the retina, and we're working on medicine. So that's very different from our great legacy and history and vision, which is primarily front of the eye and largely surgical and contact lens. So we're able to take advantage of that heritage and that gets us into major eye centers, gets us to know the specialists who -- in both academic and clinically who can help us understand the patient needs and patient journey better. It's similar to how we can also leverage our deep expertise in vascular biology, immunology, neuroscience. We're leveraging all of these things to be able to build a world-class portfolio in retinal disease and, at the same time, attract world-class talent, which we've done. We put a discovery center in South San Francisco, specifically with a retina discovery team there, and I think we're making really tremendous strides there. So that's how it fits together.

And I would really think beyond leveraging Vision Care because we are leveraging the entire enterprise when we think about our pharmaceutical development. For example, we know that gene therapy is a surgical procedure. And one of the things that we're going to need to do for back of the eye is train surgeons. And I think about the dynamic work that we've done in our orthopedics business and the Ethicon business. And we are learning from all of that experience and leveraging all of that experience as we move forward across our businesses.

Lisa, can we take another question from the platform?

Sure. Given the first FDA-approved therapy in Alzheimer's, what are your immediate and longer-range goals in that space?

Yes. Great. I'll take that question. So this is such an exciting time in neuroscience. It's really an era that we've never seen before. What we're seeing now is fundamentally advances in our understanding of brain diseases, including neurodegenerative diseases, that really fuels a new way of thinking about diagnosing and treating patients. Alzheimer's is a great example. Now legacy of over 100 years of knowing about Alzheimer's in terms of its original description within Janssen, more than 20 years' experience that we have, starting with symptomatic therapies, moving to disease-modifying therapies, learning along the way, and that's where we are today. So what we're seeing today is that driven in part by precision and patient identification, identifying those individuals who have pathological forms and protein that we're targeting. We have an active program, as was mentioned earlier, a tau antibody that's targeted towards the mid-domain of the protein. That's the pathological form that is implicated in the sort of spread from cell to cell. So by identifying patients who have that particular form, intervening with a very precise mechanism, beginning with our passive immunization program, our immunotherapy program and then expanding as Mathai mentioned into our active immunotherapy program, this is really we see not only the future but a future that we hope to actually lead. To our knowledge, we have the industry-leading platform around intervening with tau for both the passive and the active immunization approaches combined with our biomarkers and data science efforts. We see the future very bright. This is -- when it comes to neurodegeneration, we're at the beginning of the beginning. And so I think to directly answer the question, the recent awareness of the importance of identifying biomarkers that can be linked to clinical progression and beginning to offer conditional approval to therapies that reduce the biomarkers, this is the beginning. This is what you've heard from Peter today very elegantly around where oncology has shifted. We think this is where we are going with the neuroscience. We think Janssen is well positioned to lead in intervening disease-modifying strategies for neurodegenerative diseases like Alzheimer's.

Thanks, Bill. Is there another one in the room. Jayson?

Yes. Maybe just sticking on the neuro side, and hopefully, this isn't an inappropriate question. But just I want to ask about SPRAVATO. A couple of years ago, there was a lot of excitement here at this meeting, seemed absent from your commentary today. So can you just maybe walk through some of the hurdles you've faced? And do you still view it as a $1 billion -- potential $1 billion revenue stream? And if so, what do you need to do to get there?

Let me just start maybe with the science, and then I'll turn it over to Scott because first of all, the enthusiasm that you heard about several years ago, that has not diminished. In fact, quite the opposite. This is a very important molecule, the first and only NMDA receptor antagonist approved to treat treatment-resistant depression. That is individuals who've already failed 2 therapies. In addition, we gained another approval around treating MDD, major depressive disorder, associated with a suicide ideation or behavior. So it's MDSI. So what you have in SPRAVATO in a relatively short period of time is a novel mechanism of action that's intervening to truly save lives. And it's doing so in patient populations that are resistant to or not being addressed with the current therapies. So that's the enthusiasm that we have. I think that I would say that we have gained multiple approvals. We have a global footprint. We're continuing to increase the approvals. We're thrilled with the number of sites, the number of patients being treated. And maybe I'll turn it over to Scott for a broader perspective.

Yes. And our excitement has not diminished at all. This is just an incredible asset. As you recall, we had to build a new capability in the marketplace, not necessarily for Janssen, but that was getting psychiatry the ability to actually administer a product in the office. Today, we have 1,000 treatment centers that are actively treating patients. While there was an effect due to COVID-19, what we do see is patients are returning back to health care, and they're back in the treatment centers. More importantly, in addition to the 1,000 treatment centers we have, we're seeing productivity per treatment center continue to grow quarter-on-quarter. And that's what's giving us confidence that the adoption of the product is going to grow. And the final thing is, as you recall, we launched with TRD, treatment-resistant depression. And now we have MDSIs, a new indication that was launched last year. And so we're excited about both of these indications. This is an incredibly important medicine especially at these times where a lot of people were socially isolated. And as patients continue to return back to consuming health care, this is a product that still has an incredibly bright future.

Thanks, Scott. Lisa, do we have another question from the platform?

Yes. For nipocalimab program in CIDP, to what degree are you planning to strictly target patients with confirmed antibody-driven disease versus more of an all-comers approach?

So thanks for that question. We -- as I mentioned in my spotlight session, really pleased with the orphan drug designation we've received for CIDP. The plans are underway for global development, and we have not yet disclosed the details of that particular program.

Is there another one in the room? Matt?

Matt Miksic from Crédit Suisse. One follow-up on sort of a broader question. You've talked a fair amount about data sciences element of your platform and the progress that you've made over the last several years. And you've laid out a pretty significant inflection in some of the filings and pipeline plans that you've described today. I'm just wondering if you could talk a little bit about how different -- how much of an impact that has had in that inflection? And importantly, how differentiated and sort of proprietary and leverageable is that platform versus what do you think some of the other competitors are doing in the field?

I think a lot of us could -- yes, maybe I'll..

Yes.

All of us could...

How much do you want to know? So it's embedded in the fabric of our organization. So -- and I'll just give you a couple of examples with nipocalimab, for instance. As we are sailing into the new area of maternal fetal medicine, understanding the natural history of the epidemiology and all the background as we show how nipocalimab, the efficacy in our clinical trials will be dramatically enhanced with the real-world evidence and other investments that have data sciences. In other parts of the portfolio in immunology, we're deploying data science techniques to enhance our clinical trial recruitment in competitive spaces, for instance, to both shorten time lines, increase productivity. And then on the discovery -- we also have digital outcome measures that we're deploying in our clinical trials. We think dermatology and pictures are much better than human eye, particularly with a fully quantitative methods, endoscopy methods in our IBD studies. We're going beyond central reads to automated reads. So you just keep thinking of the step change in quality that comes -- and more precision we have as we understand how our drugs work. So just a little riff on that for one part of the portfolio. I'll turn to my colleagues for maybe some others.

Yes. I was guessing again mentioned on the pulmonary hypertension front. You heard from Mathai earlier, working closely with Najat's Group. We're really looking at how we can close the diagnostic gap, which is a really critical thing for a progressive disease. And as Mathai showed with a couple of programs that we're looking at, we think we can reduce that time for a diagnosis by 18 months or more. So I think this is really, really critical. More importantly, because then we can get patients on the best optimal care earlier, which ultimately should improve their long-term outcomes.

Maybe I'll just close with one neuroscience example. As David said, we could cite several. But our Phase III seltorexant program for adjunctive major depressive disorder, this is our phase -- the first to our knowledge in psychiatry that's employing an external control arm. So this is really critical. We've talked about sort of day 1 value launches. How do we ensure that we're developing our molecules in the right patients, going after the right end points that truly are differentiated in what can be viewed as a highly genericized space despite this tremendous unmet need. And being able to incorporate external control arms into our Phase III program, we think, is not just a scalable but a reusable insight that we can apply across our portfolio within neuroscience and beyond.

And I would mention that it's not just in the R&D organization where we're leveraging data sciences at Janssen or within Johnson & Johnson. And what we're truly trying to achieve is to select and demonstrate the benefit of our products on the right patients. But we also want to understand our patients' journey, where the patients are, how we best serve them at launch and real-world evidence when our products get into the world. So it really is not just an R&D exercise but also a commercial exercise, a supply chain exercise. And I think we're uniquely positioned through the integration of those elements versus our competitors within the market.

Thanks, Vanessa. I think we have time for one more in the room. Chris?

Chris Schott, JPMorgan. Just maybe 2 quick ones from me. First, help us a little bit on STELARA and the biosimilar erosion. It seems like we got maybe like 2 book ends of -- one had REMICADE held up really well through biosimilar competition. I guess on the other hand, we've got AbbVie talking about 45% plus erosion of Humira within a year of biosimilars entering. So where do you see STELARA kind of fitting in the -- as we think about kind of '23 and beyond? And what type of pressures you face for the business? And then my second question was on the Factor XIa. To get to that $5 billion peak, is this something you see taking share from products like ELIQUIS or XARELTO? Or is the opportunity here really playing in spaces where the Xas couldn't go?

I'll take the first question. So we look at STELARA, First of all, STELARA has had just an incredible growth rate. If you look at where we're performing right now, we have about 21% growth on a worldwide basis. Most of that growth is coming -- actually all of it is coming from IBD and Crohn's disease and ulcerative colitis. So we look at STELARA, it is and will remain a highly competitive asset in the space of IBD and so forth. The second thing is that like REMICADE, STELARA has a lot of brand loyalty. It is a transformational medical innovation in IBD. It was a really important alternate mechanism of action, and it continues to have a really important place in the space. And finally, it continues to move to earlier lines of therapy. So if we look at STELARA's growth, it's moving into an established earlier lines of therapy in the naive population. So as we see that growth, we expect it to continue to go in the next several years. As we look across our entire portfolio, our strategy, just like it was for REMICADE and REMICADE went LOE, it was all about the entire portfolio. Our ability to develop the pipeline that you've been seeing here all morning is really going to demonstrate our ability to drive above-market growth in spite of potentially some LOEs in the future. And it's important to remember, too, that during that time, it wasn't just a REMICADE LOE, we also have had to overcome a ZYTIGA LOE in the United States. So we had those 2 compounding factors and yet still produced above market growth. We expect to do the same in the future. With respect to the modeling, it's -- we recognize this is a very different time now than it was in REMICADE went LOE. Biosimilars were early, but REMICADE is a medical benefit product where there's less controls. And so it's a very different space than where STELARA is going to be. And with that being said, we had -- we're not strangers to competition from a J&J perspective. We've been in the space of autoimmune diseases for more than 20 years. We've had a portfolio approach all along. That strategy will continue as we look into the future. And so it's really hard for me to make a prediction as to where the model is going to go. And I wouldn't say that I would really use the European model in the United States because we do have a different payer system.

And for the Factor XI question, the current anticoagulants are great drugs. They're great drugs. And yet there's a huge amount of existing unmet need despite their presence. So despite XARELTO being available, 1 in 4 deaths worldwide is still cardiovascular and thrombotic in nature. And that's where these existing anticoagulants are either underutilized or not indicated. And the big block there is to get the right benefit to risk profile. And that's where Factor XI, by going higher up in the coagulation cascade, by the sort of supportive data that we've seen genetically, preclinically that it's really involved in amplifying clots as opposed to hemostasis, we think that we get a safer profile that can allow anticoagulation to be brought to these many more spaces and patients who can't benefit from it today. And our recently published New England Journal paper in the total knee replacement study bears out that type of a profile where we see increasing efficacy with increasing dose, very flat bleeding curve, no major bleeds in the no vaccine group in an over 1,200-patient study. And so we look forward to the second Phase II trial, which will be finished next year in secondary stroke prevention, looks at another risk population, looks in the setting of antiplatelet therapy. But really that combined data set between the 2 Phase III -- the 2 Phase II trials should then inform how much further we can take anticoagulation to protect these 1 in 4 deaths that are currently happening.

Great. Well, thank you for all of your questions. I'll now ask the team to return to their seats. And I have the distinct pleasure of welcoming Jennifer Taubert and Mathai Mammen back to the stage.

Wow, it's been quite a morning. On behalf of our entire Janssen leadership team, we'd really like to thank you for your attention and for your engagement so far today. After hearing from our talented leaders, we know you have a deeper appreciation for why we are so excited about the potential that our key brands have to reach even more patients. Additionally, hopefully, you've got a great understanding of our very deep and very diverse pipeline of what we believe will be transformational assets and also the breakthrough science that are going to drive both our near term as well as our long-term growth. So together with our 40,000 Janssen colleagues around the world, the leadership team that you saw today really makes everything possible, delivering transformational medical innovation that changes lives. We couldn't be more proud of our entire global team. So just as a reminder, as a result of their collective efforts, we anticipate above-market compound annual growth of at least 5% through 2025 with growth expected every year. And by 2025, we expect to be a $60 billion pharmaceutical company.

Thanks, Jennifer. We've told you a lot today about what to expect. We've told you that we're expecting 36 important product expansions on our current in-line products. We've told you that we're going to create 14 really important medicines. These are really impactful medicines with peak year sales averaging $4 billion. We've told you all this. We've told you that we're going to be able to grow, as Jennifer said, right through any loss of exclusivity and are very confident we're going to do that. I've got a couple of questions on the platform on how are we doing that. Like I've mentioned and I've alluded to a step-up in productivity that goes from 4 products every several years to 8 products every several years to maybe 10 products every several years. How are we doing that? And I want to just reiterate a couple of the things. I mean ultimately and the first and most important thing, it is having this team. This -- in any human endeavor that's hard, there is a big difference in outcome between having someone really good at their job and having the top people in the world. And so to be able to leverage true insight and build on that, it doesn't just happen. It's our organization that's able to attract those individuals and develop them to allow us to build on that kind of insight for truly world-class people. The second, I do want to emphasize our DAS and PAS balance. I think that's very important. Diseases that we know well, we're able to invest in very knowledgeably such depth of knowledge, whether it's on the clinical development side and the commercial side, market access, regulatory side. But we know that there's a world of new science and new diseases. How to balance that is actually a key aspect of our strategy. There's a third and a fourth. The third is the scientific and operational platforms that we put into place, what Rich Tillyer has created in the last several years scientifically and allowing us to pursue areas of medicine that would have been very difficult without those clearly in place and using the best and highest quality science really important. That's allowed us to step up in productivity in part. And finally, data science, it came up in the last panel, but this is a fundamental change. And I do encourage you to watch the data science and digital health video exhibit that Najat recorded and was released yesterday. It is a fundamental change to how we operate, how we pick targets, how we invent them and optimize them molecularly, and how we choose the right patients, how we develop them ultimately and how we go forward into the marketplace. As Vanessa said, it's throughout Janssen. So proud of the team fundamentally and Jennifer and I thank you for all of your time. Happy to take questions if you have them.

Danielle Antalffy from SVB Leerink. I appreciate the commentary around the products that you expect to reach $5 billion plus. I'm just curious if you could, a, give a little bit more color on what those products are? And, B, also what you're factoring in to build those forecasts particularly given the potential pricing dynamics with what -- we'll see what happens, but with upcoming legislation?

You want to start with the assets, and then I can talk about the pricing environment and how we do the valuations?

Sure. There are a number of really big products that we believe are coming. CARVYKTI, we spent quite a bit of time on that. But just to reiterate, it's got a role in many forms and stages of multiple myeloma. And we believe the data that the teams are producing so far are truly best in class. So maybe start with that one and I'll go over.

Yes. If we take a look and actually quite broadly, we take a look at the level of unmet medical need, and we plan out really what is that level of transformational innovation that we're going to be bringing to market. And I believe as Vanessa said in one of the earlier segments today, we do very, very thorough work to make sure that we are actually developing the evidence package. So through our clinical development programs, we develop the right evidence package to be able to get the right value for that innovation in the market. And so we take a look at all the innovations. So Mathai just mentioned CARVYKTI. We can talk about the TARIS platform for bladder cancer. We can talk about the others. But we really take a look at what that level of unmet need is, what we're going to be bringing to market and then work to build that out. I think as we take a look in any environment, in any year, I think that we would be having this conversation, the topic of pricing would come up, right? And so we really take a very responsible approach. And I know you know that actually 100% of our growth comes from volume, not price. So as a company, we are among the best positioned to be able to succeed in environments where there's pricing questions. We really believe that based on the transformational innovation that we bring forward and the value propositions that we're able to document that we'll be able to continue to get the appropriate value for our medicines in the future even despite continued pricing questions and things like that in various legislation.

And that is the key, as Jennifer said, is to only do projects where we believe we're creating something that's a completely different step-up from anything that, that patient might have access to at the time that, that product launches in the future and create the evidence that during clinical development to show that that's unequivocally true. And so whether it's CARVYKTI, lazertinib with RYBREVANT, or the entire bladder cancer approach that we're taking right now or nipocalimab or milvexian, we will have at the time that we go forward into the marketplace, deep differentiation. And that's what makes us comfortable.

Yes. There's -- hopefully, you saw today, there are no me-toos in this pipeline and the type of outcomes that we are looking to deliver are truly transformational. So we believe we'll be able to get the right value for those products in the market.

[indiscernible]

Give a mic right there.

It's Matt Miksic from Credit Suisse. So Mathai, I wanted to just give you an opportunity maybe to talk a little bit about the way forward with the COVID vaccine program. Maybe what do you think investors or patients or governments or the community don't quite appreciate in terms of the progress that you're making? And what do you think the value add is for this program over the next couple of years in terms of differentiated delivery and dosing, et cetera?

Yes. It is a good question, and I'll start and then maybe, Jennifer -- I'll turn it to Jennifer. And Penny Heaton and Vanessa Broadhurst addressed this very nicely on the panel as well. But from my perspective, we've created something extraordinarily valuable in helping protect the world. So what this -- what the WHO typically recommends is put out a vaccine that is -- provides solid, really good protection against the most severe outcomes like hospitalizations and death and make it a single shot. And that's exactly what we did. And once the population is secured, worry then about optimization. And then what we did most recently is go forward with a booster strategy of 2 6-plus months, and that optimizes the protection. So we've done exactly that. And what we're seeing now is in different parts of the globe, the populations are at different stages. And in the United States, we're thinking about that optimized protection at the moment. And over the years, we'll develop the right regimen to boost people in the right ways, repeatedly probably. And our vaccine will play out, I'd say it's not clear yet, but in the 6 months, 12 months, year or 2 ahead, the data sets will all mature, and we'll see how that goes. In other parts of the world where the vast majority of the population remains unvaccinated, our vaccine will provide that first foray in. A feature of the vaccine that we're really particularly happy with is that it's long lasting. It really does have a durable -- because of this strong induction of an immune memory component, it's a long-lasting effect. And that's going to stand the world in good stead as the years go forward.

Yes, very nicely said. I think going back to the comments that you made around WHO. So if you think about in a pandemic, what do you want? Ideally, you want a single shot vaccine. You want something that prevents the most serious consequences and you want something that can be easily distributed and administered. And our COVID-19 vaccine really hits on all 3 of those dimensions. So right now, for this year, we are really focused in on delivering, and I'm really proud to say, over 60% of the volume that we're producing is actually going to low and middle income countries where it's most needed right now. Many parts of the world, the vaccination rates are still under 10%. And as we look at next year, we're looking at producing 1 billion doses plus and again, helping ensure that first vaccination for many parts of the world. I think we need to make sure that the whole world is secure to be able to help move on from this. And then we're taking a look at boosters. So we've got studies underway. We're going to take a look at the data and really follow the science, and we'll be able to provide more guidance as we move into 2022 on that. Probably have time for maybe one more. There's another one.

Yes.

Just a follow-up on the last line of questioning. Do the economics or pricing change much on the vaccine next year versus this year?

So right now, we're working on fulfilling the contracts and all the demand that we have right now. And as everyone knows here, I believe we really -- when we went forward with our big commitment, thought that it was really important to put this product forward at a not-for-profit price. And so we're working right now and really through predominantly the course of 2022 at a not-for-profit price. And then we'll take a look if the market evolves and with boosters and such, if and when there's a right time to convert that over to commercial pricing. Okay.

Can I sneak one more in, if possible? It's Chris Schott. It seems with the -- with nipocalimab, you're running this parallel development program and enabling kind of much faster time to market with a lot of indications. Is there an ability to more broadly apply that across the portfolio? And then I think about in a world where we may eventually have some more price competition coming at the end of product lives, et cetera. Kind of getting a full suite of indications earlier could add a lot of value, I guess. So when you think about development time lines, et cetera, is there a way, I guess, to take more risk earlier and once you have proof of concept, kind of roll out 3, 4, 5 different either indications or kind of opportunities in parallel versus staggering them a bit more than you've done the past, I guess?

Yes. Let me start with that. It really depends on the confidence that we have scientifically that this is going to be an important mechanism. If we're coming out of an important proof-of-concept study with broad-based multiple indication confidence, then that's exactly what we would do. And that's what you're seeing right now with nipocalimab. There's a simultaneous start of multiple paths at the same time because of confidence in that mechanism alleviating multiple kinds of diseases. There are other instances where the proof of concept gives confidence on a particular indication but doesn't necessarily translate to other indications because the biology may be different. In those cases, we'd look at the entirety of the portfolio and decide always like on a year-by-year basis where the best investments are to help the most -- patients the most deeply and impact life that way. So you're seeing in nipocalimab an example of the former of what happens when we have great confidence that's broad-based in the mechanism.

Yes. And Chris, hopefully, you see that nipocalimab program is really a wow. So going in after 11 indications very, very quickly. If you think about the pharmaceutical industry of old, there would have been 1 indication and a few years later, another and so on and so forth. I think this is one of the things that part of the power of Janssen and Johnson & Johnson that we've got the ability to tackle really, really big programs and to go in, in a very big way where we believe we're going to be able to be transformational. As was mentioned today, we believe that in many of these areas, we're actually going to be first to market. And that gives us the opportunity to get in to help build the market, to help define really what that market should be, the value that should go for those innovations, et cetera. And so we'd much rather be first in than be somebody who's a follower and comes later. So what you're seeing is exactly part of our key strategy in terms of how can we go big and go very, very quickly. And I think that that's a key strength and a core competency. So you see it in nipocalimab, but you also see it across so many of the products that we discussed today, where we think that there's broad application. I won't go through all of them, but you could just take a look at even a product like DARZALEX, and the breadth of indications and what we have, relatively speaking, so early in that product's life cycle. So thank you. Well thank you for taking the time to join us today. Right now, we're going to take a short break, and then we'll resume with our enterprise roundtable discussion with Alex, Joaquin, Paul and Joe. So thank you again.

Thank you.

Ladies and gentlemen, we will now break for lunch. Our meeting will resume in 20 minutes. [Break] [Presentation]

Ladies and gentlemen, please take your seats. Our program is about to resume. Ladies and gentlemen, please welcome Executive Vice President, Chief Financial Officer, Joe Wolk.

Well, hello, everyone. While you're enjoying your lunch. I just want to share with you an experience I've had with talking to some of you, and many of you have come up graciously today and say thanks for holding the event. Really, it's thanks to all of you for coming out to our New Brunswick headquarters and really sharing in the energy and excitement of the day. For those of you who are joining us virtually, I hope you have a chance to grab a bite to eat and we'll look forward to seeing you very soon in the near future. So as I reflect on yesterday's videos, exhibits and then this morning's comments, it's really with great pride that we share the many transformational innovative medicines that we have in our portfolio, not just today but really what lies ahead in the future, which continue to surpass the expectations with so many patients that they reach and benefit each and every day. It's truly extraordinary that I stood here just only 2.5 years ago telling you that our Janssen business would be comfortably above $50 billion in revenue by 2023. And I remember at the time that surprised, favorably, most of you. Well, here we are today, and it's going to arrive about 2 years early. And as Jennifer shared earlier, we remarkably expect our Pharmaceuticals business to grow to roughly $60 billion by 2025. Now we're really proud of that performance and excited about the trajectory of our Pharmaceutical business. But we're also eager to speak with you today and answer your questions about the long-term growth outlook for Johnson & Johnson, And of course, the announcement we made last week regarding 1 great company becoming 2 great companies. I know Alex touched upon this briefly, but I also wanted to share some thoughts about our decision. Based on deliberate, thoughtful and extensive discussion and analysis, we are very confident in the plan to separate our Consumer Health business. Now we are constantly evaluating our portfolio as well as our structure to ensure that we set ourselves up to best achieve our goals and your expectations, both now and in the future. This evaluation includes looking at the composition of our portfolio in relation to the wider market and the industries in which we play. Our intention to complete a separation of our consumer health business is in line with our history of making bold purposeful shifts to address unmet medical needs and prioritize science-based innovation. Our broad-based business has historically served us very well, but the global environment as well as consumer trends, both today and tomorrow, now demand unprecedented focus, unprecedented innovation and unprecedented agility, which we believe will best be served through 2 great independent companies. The world and the operating environment continue to rapidly change. And we recognize and more importantly, are acting upon the fact that worked best yesterday won't necessarily work best tomorrow. Now there have been a few questions regarding -- that have been recurring, I would say, over the last few days since last Friday's announcements from employees, retirees and the investment community, which I'd like to address at this time. The first is what will happen to my shares at Johnson & Johnson. The Board of Directors' intent is to effect the planned separation through the capital markets, creating 2 independent market-leading companies. As you can probably appreciate, there are many details to be worked through and thus, many decisions yet to be made. But to be transparent, there are, quite frankly, multiple capital market separation pathways being considered. It could be a straight spin whereby owners of Johnson & Johnson shares simply receive shares in the new company. Alternatively, the process could begin with an initial public offering or an IPO and then followed by a spin. That same IPO process could also be followed with a split-off transaction instead of a spin, which simply means owners of J&J can elect to exchange shares for shares in the new consumer health company. There are a number of factors and nuances such as the broader market environment and ensuring that the transaction qualifies as a tax-free separation. These will impact our decision as we seek to determine the ultimate and optimal pathway for the new consumer health company, our employees, customers and shareholders. We will be working through these various decision points. And we'll have an update for you on the goal chosen likely in the second half of next year. But make no mistake. We have strong conviction in both the strategic and financial rationale for this planned separation. And we believe it will enable both companies to achieve greater growth and profitability through intense focus and opportunity. Another question that comes up. What about that reliable Johnson & Johnson dividend? Now we intend for both companies to be well capitalized, generate significant cash flow and have strong balance sheets that warrant strong investment-grade profiles. Additionally, we anticipate that the overall shareholder dividend will remain at least at the same level following the completion of this transaction. More specifically, for the new Johnson & Johnson, our stated capital allocation priorities remain intact, differentiated investment and innovation, which was clearly on display today, competitive dividends increasing annually, pursuit of strategic and value-creating acquisitions, and when appropriate, share repurchases. Similarly, we anticipate the new consumer health company will pay a dividend and be positioned to invest prudently in both organic and inorganic growth. And the final question that's been pretty consistent, when will we know more and what's next? And I can appreciate you're all eager to update your models with items like stand-up costs, possible dissynergies and tax implications. Clearly, we have a preliminary estimate for all these points to get to this point. We will continue to refine these estimates and work diligently to mitigate responsibly any incremental cost when we're facing them. There are many decisions to be made, as I said, but we have assembled a strong leadership team to work through all of these factors. Our plan is to provide you with timely updates on important decisions and further clarity on financial estimates at our upcoming quarterly calls and whenever else may be appropriate. We are very excited by the tremendous opportunity this step represents for our business, our stakeholders, our shareholders, and the people that we are privileged to serve. And I suspect you may have your own set of questions on this topic, but before we jump into the Q&A, let me welcome to the stage to discuss this priority and others he has top of mind, our incoming CEO, Joaquin Duato.

Hello, everyone, and thank you for being here. We are looking forward to spend the next 40 minutes answering your questions. But before I go there, I would like to share my perspective with you on the future of Johnson & Johnson. As a matter of fact, this is the first time that I'm meeting with you live since it was announced that in January, I will have the great privilege to be the eighth CEO of Johnson & Johnson. And this privilege is compounded by the fact I'm going to be succeeding a leader like Alex Gorsky. I have worked with Alex side-by-side for the past decade. And I can say confidently that he is a once-in-a-generation leader. And I also would like to take this opportunity to thank Alex. Thank you, Alex, for your mentorship and support, and thank you for leaving Johnson & Johnson very well, working fine in all 3 sectors in a strong position moving forward. I'm also grateful, Alex, that we're going to continue to work together in your new role as Executive Chairman. I'm deeply honored to become the next CEO of this remarkable company, especially at this unique time in history. Now it is a moment of incredible opportunity for health care and Johnson & Johnson is positioned for growth. At the same time, we recognize that there has been change with our recent announcements. But our willingness to evolve, to ask tough questions and make bold decisions are what has allowed us to be able to thrive during 135 years. But please understand one thing, our core values and our purpose remain the same. We always put the patient at the center, and we always have our credo as our guide. In line with our commitment to meet the health care challenges of today and beyond, we are now taking steps to separate our Consumer Health business into a stand-alone company. We are confident that the creation of the 2 companies, the new consumer health company and the new Johnson & Johnson is the best way to improve health outcomes and to create value. After working closely with consumer health over the last several years, it is clear that consumer expectations are evolving at the speed of Instagram and same-day delivery. Once separated, this new company will have greater investor visibility and greater flexibility to accelerate innovation and advance category-leading positions. And importantly, we are making this change from a position of strength. Our Consumer Health business is competitive with 5.7% adjusted growth in the last quarter and has a top-quartile margin profile. We expect this $15 billion company will continue to be a global leader in the consumer health industry, competing in the growing markets of self-care and skin health. Larry Biegelsen from Wells Fargo just published a report over the weekend, showing that 16 out of 19 similar transactions have created value for shareholders. So we see a truly exciting potential for value creation. And for the new Johnson & Johnson, well, we are positioned to take on the next frontier of health care and accelerate growth. The future of pharmaceuticals and medtech is interconnected. Disease will be prevented, treated and ultimately cured through a combination of both surgical interventions and pharmaceutical treatments. And the new Johnson & Johnson remains the largest, most diversified health care company in the world with sales close to $8 billion -- $80 billion. We will maintain the benefits of diversification and scale and will use those benefits to invest in R&D and to grow our business in new ways through M&A. Let me start now with our pharmaceutical sector. We have driven a step change in our R&D productivity with 14 new therapies to be filed through 2025 with more than $1 billion potential. Coming into this meeting and when we were meeting with you, your #1 question was, are you going to be able to drive continued growth over the next 5 years? The answer is, yes, we will. Yes, we will. Our Pharmaceutical business is well positioned for $60 billion in sales by 2025 and growth in each and every year despite of patent expirations and above-market compounded average growth. Now let's move into our medtech sector. Standing here today, I recognize that many of you have known me and think of me as a pharmaceutical guy. In preparation to assume the role of CEO, I have traveled around the world to meet with our medtech teams. And in each visit, I have learned more about the quality of our innovation pipeline in medtech and the strength of our management team, ensuring medtech growth to a best-in-class performer will be a defining moment in my tenure as CEO, a defining moment. Over the past 3 years, the medtech team has been on a journey of improving competitiveness and has begun to demonstrate success with sales improving from 1.5% in 2017 to nearly 4% in 2019. We are seeing market share holding or improving in nearly all priority platforms. We accelerated further in 2021 with 5% growth year-to-date versus a more normalized 2019, and we plan to continue this trend into 2022 and beyond. That being said, we recognize that we are not yet there. We recognize that we have gaps in our portfolio, and we plan to use our strength, our scale and our financial muscle to address those gaps. I'm absolutely committed to our medtech sector and look forward to growing the business in new and exciting ways. In closing, I want to be clear on my 3 priorities: one, ensuring the successful creation of the new consumer health company and industry leader delivering personal health solutions and unlocking value for shareholders; two, continue to drive medtech to become a best-in-class performer by focusing on delivering patient-centric innovation and enhancing our market positions; and three, delivering on the promising pharmaceutical business commitments and long-term growth goals that we have shared with you today. All these priorities will ensure Johnson & Johnson remains the largest and most impactful health care company in the world for the next century. Thank you, and we look forward to answering your questions. Please join me in welcoming to the stage Alex Gorsky, Joe Wolk and Dr. Paul Stoffels.

Okay. So I think at this point, you guys know the drill. If you have a question here live, certainly, just raise your hand, state your name and the firm you're representing. And for those on the virtual platform, please feel free to use the capabilities there. So let's see our first question. Matt Miksic?

Matt Miksic from Credit Suisse. So maybe Joaquin on your last point about bringing med devices to sort of best-of-class performance levels. I think one of the questions that's come up again and again over the years has been whether or not a large acquisition or a large deal or some strategic investment was going to be part of that solution. And I think most folks would say the last 5 years, that has not been, and you found other areas to invest. Maybe talk a little bit about the challenges if you see them in terms of putting strategic assets to work in med devices and then maybe as a balance, the importance of the cash flows generated by med devices and funding some of the other great programs that we've heard about today.

Thank you. That's a great question. And I want to reiterate the fact that the new Johnson & Johnson with close to $80 billion of sales will remain the largest and more diversified health care company. So the benefits of the diversification that we have spoken multiple times about will continue to exist for the new Johnson & Johnson. We'll be able to use our scale and our financial muscle to always have optionality. For what concerns our medtech business, we'll continue to invest in our pipeline. We have an exciting pipeline. Our pipeline has been more productive than ever and that is helping us in creating a new cadence of new products to get more competitive in different areas. When I was visiting our different medical device side, I was very excited about many of the things I saw there. For example, I went to visit our CSS team, our Biosense Webster team in California, and I saw these new microcatheters for treatment and diagnosis that they are developing that are going to enable us to reduce the procedural time. I also saw a different type of pulse ablation utilizing electric, control electrical fields that replace thermal energy. So different innovations. I went to see our orthopedics team. I saw the progress of our VELYS system, I saw the products that they are doing with cementless knees, bilateral hips, many different things that make me very confident that we are going to continue to regain competitiveness as we are doing, and we'll be able to invest in our pipeline to deliver innovations. As I said, we recognize that we have areas that we need to feel that we have adjacencies that we would like to reach, and we are willing to look at that as an area for us to continue to invest into the future and to make our medical device business, our medtech business a great performer. I mean when you think about it, our medtech business has 11 platforms of more than $1 billion. So we have the scale, we have the reach to be able to be the best performer and the best medical device company, and that's going to be something that we're going to be pursuing. We'll utilize our expertise internally, but we are also willing, as we have done, to utilize external innovation and M&A to get there.

Thanks for the question, Matt. Larry?

Larry Biegelsen, Wells Fargo. Alex and Paul, congratulations on all you've accomplished at J&J and best wishes in your retirement. And Joaquin, thanks so much for the shout out. So a question for you, Joaquin. Consensus is modeling well below $60 billion in pharmaceutical sales, excluding the COVID vaccine in 2025. You guys expect to be above $60 billion. Where do you see disconnects between your outlook and what investors are modeling?

We see disconnects in 2 areas. One is in the potential of our existing products, talking about DARZALEX, ERLEADA, TREMFYA, even IMBRUVICA. But the biggest disconnect is in the newest products that are going to come. That's where we see many of you not modeling or not modeling appropriately those products. We discussed them today, CARVYKTI, nipocalimab, our TARIS platform. So those are areas that we think that there is a disconnect that we hope and part of this meeting was to try to illuminate that, Larry, to try to provide you more information so you can better model these new products that are coming up in the 2021 to 2025 period. So I hope that helps. But those are the 2 biggest areas of disconnect that we see.

Thanks, Larry. Let's go to Louise, and then maybe, Lisa, we can tee up one on the platform right after this.

Louise from Cantor. So first question I had is on the $60 billion pharma revenues, how much of that is internal? And does that include any M&A? And if not, what could -- how should we think about the potential upside there? And then, Paul, thank you for all your contributions to J&J and humanity. Who do you think or what type of person is the right one to fill your shoes, especially under the new J&J?

So let me address the first one. All what we have presented is what we have now. It doesn't include any additional M&A or any additional external innovation that we do. Everything that we have presented is things that we have now that they are already in later stage renal development for some of the ones that we presented and all of them are already in patients.

Well, on the future, I think what you probably have seen is that today is that there is an exceptional bench of people here who are all very, very knowledgeable about their therapeutic area and about how to make drugs. And so as you can imagine, this -- the success of Janssen is not by chance. It's by design. And at first, based on very strong people, deep insights and science, medical capabilities. It's more -- it's bench to bed, but it's even more. It's like embedded in innovation outside there, where today, we are embedded in about 1,000 companies where we can observe, learn, where we have our inspiration. And that combined gives the basis for transformational innovation. Second, it's about what do we do on this extensive accelerated development. All the people are very well versed now in breakthrough designation, accelerated development and upon approval, delivery of the product. So everything is very well set. And I think the bench is broad enough to make sure that good people grow up and you will see the next nominations coming as Joaquin takes over, but I'm very, very happy and proud to have such a broad group of people with such a successful portfolio.

And Paul, maybe if I could just add one comment. It's something that we talked about, and it's part of the philosophy of leadership at Johnson & Johnson, is that all the leaders that you saw here today fundamentally are evaluated on their performance, on their leadership development and their standard of upholding our credo-based philosophy and approach. And I think if you even look up here, what you saw today, the effort and the commitment that Paul has put into the development -- of research and development leaders because as I mentioned earlier, market dynamics, science will ebb and flow. When you have good leaders in these roles, who are there, who are deep in the science but also can work horizontally, vertically across and through teams, ultimately, we think that's what makes the biggest difference. And even if you look at the transitions, the deep bench of leaders under Paul, the successful transition with Joe several years ago -- and by the way, Joe deserves a call out. I called out Paul and Joaquin earlier in my talk, but I couldn't be proud of the job -- yes, big shoes to fill behind them. But the job that he's done stepping in, particularly over the last 24 months during COVID having each quarter go as smooth as it did, is a real credit to he and the entire finance team, the transition with Joaquin and myself. And so that -- look, that's part of our role as leaders and something that we take seriously, that we hold ourselves and we hold the entire organization accountable for.

Great. Thanks, Alex. And Paul, I know you hold Dr. Paul Janssen in high esteem. I don't think I'm going out on a limb that all the leaders we saw here today on display that that's how they think of you in terms of you being there, Paul Janssen. So congratulations on not only the value creation that you've delivered in the pipeline, but just the value creation you delivered in, as Mathai said, the world's best scientists. So Lisa?

We heard from the other panels a bit on MD and pharma synergies collaboration. Given Friday's news, can you elaborate a little further on that?

Look, as Joaquin alluded to and as I alluded to, we think continuing Johnson & Johnson as the world's largest health care products and services company, built on a pharmaceutical and medical device businesses and our pipelines and technologies is the best path forward. We have a -- we had a long heritage with our consumer business. But if we just look fundamentally at the way that so many dynamics have evolved as it relates to, for example, the clinical and regulatory pathways and the development programs, the technology supporting both of those, the distribution channels, the nature of the customer, other intermediaries involved, we saw a divergence taking place there that would result in the consumer unit having greater opportunity and potential to accelerate growth and to reach more consumers by being a separate publicly traded entity. That being said, we believe that there's -- there remains many synergies based upon the things that I just mentioned with our pharmaceutical and our medical device business. We also believe that there are synergistic opportunities, particularly as some of these sciences and technologies evolve. We've alluded to those. And I thought it might be helpful. I think -- is Bill Hait still here? For maybe even a bit of a more granular description about some of the things that we're doing, for example, in the lung cancer initiative to provide some additional detail on some of the things that we think might be possible.

Sure. Thank you, Alex. I'm happy to give you at least a glimpse that really begins with the fact that we have 2 incredibly strong units in medtech and pharmaceuticals. And it began when we realized that Auris was producing a bronchoscope, a digitally powered robotic bronchoscope that I immediately thought of as a pulmonoscope, just like the colonoscope can reach the entire colon. The Auris MONARCH can reach anywhere in the lung and some of the earliest lung cancer lesions are all the way out in the periphery. So the MONARCH can reach those lesions and in one sitting, diagnose whether this is a cancer or not and then treat. And the treatment can be with an ablation device, like our NeuWave energy device, but now we're bringing our pharmaceuticals there by delivering through MONARCH, chemotherapy. We've thinking and developing here from Peter, oncological -- immuno-oncological agents and oncolytic viruses. So imagine that you could actually treat and immunize the patient against their tumor and the immune system would find any micrometastases anywhere in the body and keep you clear from cancer by being able get to those early, very peripheral lesions. So that's just one aspect. Peter mentioned TARIS, the drug-eluting stent for bladder. Of course, MONARCH cannot just get to the bladder, but it can get up into the ureters and even the renal calyces. And then let's not forget about our contact lenses where we already have a drug, a contact lens combination for itchy eyes, where you release an antihistamine-like drug to relieve some of the redness and itching that you get in allergies. And that's just another platform that could be used when we really put ourselves together and combine our thinking in pharmaceuticals and medtech.

Thank you, Bill. Let's go back to the room. Let's see. Yes, Chris. Sorry, the light is a little bright.

Great. Just a quick question on drug price reform for the panel here. Can you just comment a little bit -- I know it's everything is still in flux, but the kind of 3 components that seem to be discussed right now of some sort of Medicare Part D redesign, some sort of kind of inflation tied price caps and then some sort of drug price negotiations. So as J&J thinks about kind of managing its exposure to this business, kind of looking at how to manage the business going forward, just would love your thoughts on just directionally, if this is where we kind of land. What does that mean for J&J? And do you think about your business differently, I guess, as on a go-forward basis with those changes going in place?

Thank you, Chris, for the question. And this is also a question that always comes up in all these meetings, reflecting the fact that the tension between innovation and affordability, it's always going to be a secular issue for the industry and for the health care industry. When we think about this situation that we're going through now, we put that into the context of the fact that this is a secular issue. Ultimately, what makes companies succeed in health care it's our ability to bring innovative medicines to patients, and that's what we can do at Johnson & Johnson. And in our case, with a very broad and diversified portfolio that historically and moving forward has dependent on volume for growth, not on price. So we are the company that depends -- of the major ones, that has less dependent on price, I would say, generally speaking. So when I think about the situation now, like in everything, there are positives and negatives, right? On one hand, we always have believed that addressing the issue of patient affordability in Part D is foundational for the system. And we think that's very, very, very important because while pharmaceutical expenses overall may be decreasing, if we don't address the patient affordability issue, there's always going to be significant tension in the system. And on the other hand, there are negative elements that could be very detrimental for innovation like government price setting. So we have to see how things shake out. On one hand, we have positive things in patient affordability. On the other side, we see that government price setting or the beginning of government price setting is something that could be truly detrimental. When we think about our future, we continue to see our future strong or stronger than other companies based on the diversification of our portfolio, the fact that we are our largest company and at the same time, the fact that our growth is based on our differentiation and not in our price.

Just a quick follow-up. Alex and Paul, congrats on all the accomplishments over the years. As you look at the new product pipeline, what are the 1 or 2 assets that you each are kind of most excited about and will be watching most closely as you transition to your new roles over time?

Well, as already discussed, today, CARVYKTI is, for example, what Peter said and Jennifer and Mathai highlighted is a transformational product. Combine that with the new antibodies, the multi-targeted antibodies, which are following, we get into cures. And I think aiming for cures is what is going to be the differentiation. Nipocalimab is a big differentiated portfolio. ERLEADA still lots to do. I think a lot of big products can still grow so far. So as highlighted, we have a portfolio of products which can become multibillion-dollar products all based in strong signs with a very differentiated profile.

Yes, Chris, as I reflect on it, having been at this now for over 30 years, I guess the analogy that I would use is we went from small molecules to biologics and that transformation that we started witnessing about 25 years ago and you look at where the industry is today. And if I catapult that going forward, I think the cell-based therapies, I think the gene therapies, I think of other new technologies, if we talk about on the digital, on the robotics, on the AI side of those being incorporated, I think those fundamental evolutions are taking place in science and technology just hold incredible promise. And look, it's -- all of you know that Paul has a long track record of underpromising and overdelivering. And for him to be sitting up here and talking about cures, I just think represents how far the biopharmaceutical industry has come that we're actually sitting here talking. But to the earlier question, it is going to, I believe, cause a fundamental shift in some of the conversation about reimbursement. When we are now curing patients, when we are significantly reducing the cost of morbidities and other aspects of care and the investments required to bring those things, I mean think what's happened over the last 24 months. Where would we be have the biopharmaceutical industry not invested hundreds of billions of dollars over decades as a society? And so I think these are important discussions, but I think it'll highlights, I believe, the promise and the opportunity that our industry can bring about.

Great. Any other questions in the room? Lisa, do we have anything on the virtual platform?

So the foundation of J&J has been your credo. Now with the spin out of consumer, how do you think about what that means to the identity of the 2 separate companies?

So that's a great question, and that's a question that our employees, both in the consumer and in the new J&J are asking us. Certainly, the new consumer company, it's going to be a mission and principle-based company, as Johnson & Johnson is, and they will have the opportunity to define their own values and principles, which are consistent with the customers and consumers they serve. So I believe this is going to be an exciting piece for the new consumer company to be able to define what values and principles they want to have. For the new Johnson & Johnson, we'll remain fully committed, as I said, with the patient at the center and our credo as the guide. At the end of the day, what matters for health care companies is that we are mission-driven companies. And when we put the patient at the center, the rest of the things come together. So that is what really generates the pride, the motivation, the energy for change that you have seen today being mission-driven and having the ability to change the trajectory of life. So I'm sure they will be excited about these opportunities.

Okay. I think we've got time for maybe one more question. Is there any in the room? All right, Lisa, back to you.

So pharm growth looks strong even after [indiscernible], but how should we think about total new J&J growth '24 and '25 -- through '24 and '25?

Yes. So listen, you've heard the story today, and I know you have confidence in what this team has been able to deliver really over the last decade. And so we feel very good that we will continue to be above market growth. As Joaquin said in his comments, we've seen a nice momentum pre-pandemic of really improvement in our medical device business. And we think that that's only been solidified during the pandemic. Whether it was Alex or Ashley or Joaquin reaching out to hospital administrators, certainly find out the status of the pandemic but also asking the question, what can we do to help, what can we do to help get to more patients who need procedures during a time when people were fearful to, quite frankly, go into hospitals. We are seeing share gains in a number of our priority platforms. And we think when the market solidifies, first of all, I think we're going to have some pent-up demand or deferred demand that will trickle into next year, possibly a little bit longer depending on the dynamics of the pandemic and how it progresses or doesn't. But I do think we're in a very solid position. And as we continue to address portfolio gaps there, we'll be very well positioned in that '24, '25 time frame to be a high single-digit growth company. Okay. Well, thank you for your time. Joaquin, I'll turn it over to you.

Okay. So with that, our time together has come to an end. We hope you leave feeling inspired with what you have heard. Thank you for spending your day with us for the first time live and for your continued interest in Johnson & Johnson and bye-bye now. Thank you.

Thanks, everybody.

Ladies and gentlemen, thank you so much for your attention. Please enjoy the rest of your day.