Great. Good afternoon, everyone. My name is Jessica Fye. I'm the large-cap biotech analyst at J.P. Morgan, and we're continuing the conference today with Seagen. The good news this year is you're not switching rooms for Q&A, so you can stay right here after the presentation. There's two ways to ask questions. You can raise your hand, and then someone will come over with a mic. You can also send me questions electronically through the portal, and they'll come up on an iPad, and then I can ask the management team up here. With that out of the way, I'm very pleased to introduce Seagen CEO, David Epstein. Thanks, Jess. It's really great to be at the J.P. Morgan Healthcare Conference as Seagen's CEO. Some of you may know a little bit about my background. I won't spend a lot on it. Suffice to say, I started at Novartis Oncology from scratch. I was employee number 1. Grew it to a $9 billion-plus business, over 6,000 employees, and then went on to become, Novartis's CEO of the Novartis Pharmaceuticals Division. As I looked at the opportunity at Seagen, I saw a few things which I believe define this company. The things I'm going to describe, present a very good match with the skills that I bring to this job. In particular, I was attracted by a highly committed, nimble workforce that does just one thing, and that's work to bring forward new medicines for cancer patients to provide them better lives and longer lives. Second, my hypothesis coming in the door was that Seagen had developed over the last 24 years, actually, very strong capabilities in quite a number of areas, but in particular, a drug development engine, run by Dr. Roger Dansey. Roger will come up and join us on the stage in a little while. In a commercial engine, run by Charles Romp, who has now launched four different drugs, multiple indications for those medicines. My other hypothesis was that this company was at a stage of growth, and it reminded me a little bit of my early Novartis Oncology days, that there was an opportunity now to dream much bigger, to build an oncology leader. Those were the premises that I thought about as I interviewed for the role. thankfully, I was granted the opportunity. I'm very appreciative of that. I can tell you now, being in the job a grand total of 61 days, so I'm not counting in weeks or months yet, just days, that my best expectations have been surpassed. There is a lot that Seagen can do to make more better medicines going forward. I put in front of you the forward-looking statements. I encourage you to read them. Obviously we have filed and online, you can get all our SEC filings. I'd like to start by just reminding what is at the core of this company, this oncology company. Four products that are currently on the market. They're all targeted oncology products. They have multiple label expansion opportunities ahead. By the end of 2023, we will have 18 ongoing clinical programs. This company was founded on the idea that antibody-drug conjugates can become a new modality that would be able to treat otherwise untreatable cancer patients. This company has leading expertise, and we will speak about that a bit more in the presentation. Now a commercial footprint that expands, extends over 17 different countries. One of the first things I've done over the first few weeks with my team is to work on focusing the strategy, so it'd be clear on how we're going to go forward, to make Seagen a stronger company, to continue to drive impressive growth and capitalize on our innovation power. The presentation is set up. We are now currently on page 4, to take you through these three pillars of our strategy. First, focused on optimizing our current drug portfolio, the products that are on the market, to reach the full potential of these commercial brands. We have multiple ongoing registration trials, which will result in label expansions and continued growth opportunities, for these brands. We will also work to continue to enhance commercial execution, both in the countries where we play today and the countries that we might add in the future. The second pillar is around prioritization. We've instilled now in Seagen a disciplined portfolio prioritization process, looking at putting our most precious resources against the best opportunities that have the chance to transform this company into a still bigger, more successful oncology company. You'll see during the presentation which of those products we think have the greatest potential. Clearly, data and science will win the day, but we've made bets based upon where we think we have the best chances of being successful. In addition, we've made bets where we can leverage the internal expertise that we've developed by putting together our vedotin ADCs with anti-PD-1s as these two agents seem to pair very, very well together. The third pillar is around innovating into next generation ADC technologies, optimizing our auristatin payloads, and then diversifying beyond vedotin with novel linkers and payloads, and then continuing the work that we've been doing to date to supplement the pipeline with complementary assets through strategic and licensing. I personally believe that our organization can develop and can now launch any kind of cancer product. We won't do things that are far afield from our core, so you will never see us doing something like cell therapy. I think just about anything else a cancer doc would use to treat his or her patients is something that we can develop and commercialize. We'll go through these 3 pillars one at a time. First, I just wanted to set up for you the currently commercialized portfolio. What we try to do on this slide is give you a sense of the growth opportunity in terms of numbers of patients that still exist for each of these brands. For ADCETRIS, Padcev, Tukysa, and TIVDAK, all significant future growth opportunities ahead. Clearly, we will need to further reach patients to achieve these goals, but also continue to generate data and expand our labeling in order to achieve these opportunities for our products. Starting with ADCETRIS, 2022 is a very good year for this brand. As we reported out the ECHELON-1 overall survival data, which has now been submitted to FDA. We have already garnered a NCCN guideline update now to category one and a preferred regimen. This makes it even more likely that a physician will choose ADCETRIS to treat their first-line Hodgkin lymphoma patients. We were granted a pediatric label expanding the opportunity for this drug during 2022, and we continue to explore this product, which is already a foundation in multiple CD30 positive expressing lymphomas. In fact, we have seven approved indications. We are now studying this product in DLBCL as well as other solid tumors. We would hope to have some of the solid tumor data for you in the first half of 2023. Moving on to Padcev, this is our second blockbuster product in the making. ADCETRIS, we're getting close. Padcev will take a little bit longer, but I'm quite confident we have a very good shot at getting there. On the left-hand side of the slide, you see the, what we call the Cohort K data. This is looking at Padcev in combination with KEYTRUDA in first-line, metastatic bladder cancer. FDA recently looked at that data and granted us a priority review date of April 21st, 2023. You can see, once again, of the vedotin ADC, in this case, Padcev and KEYTRUDA pair extremely well together. You can see, the response rates, and the depth of, I should say, the depth of responses, on this particular chart. We would hope that accelerated review would be... Well, it has been granted. We hope this product will be approved around this priority review date. Our real goal with this brand is to continue to move up. We are currently standard of care in the second-line setting. The accelerated review will be the first shot at a first-line setting in cisplatin-ineligible patients. We continue to do work, for example, with our EV-302 registration trial. That trial where enrollment is now complete will give us the opportunity to treat both cisplatin-eligible as well as cisplatin-ineligible patients in the first line. That will greatly expand the patient population. We have ongoing trials called EV-303 and EV-304, where we're studying the drug in muscle-invasive bladder cancer in a curative setting. Moving up to still larger numbers of patients. Last but not least, we are exploring this product in non-muscle invasive bladder cancer, which are very, very big segments. For there will be initial EV-202 data expected in the first half of 2023. You can see with all this ongoing activity in these larger patient populations why I'm particularly excited about this brand. Moving on now to Tukysa. Tukysa is our first small molecule launch. As it is being used in treatment of breast cancer, and particularly those breast cancer patients who have brain metastases, where the product has a unique benefit. We are currently also awaiting a January 19th PDUFA date for the use of the product in second-line plus metastatic colorectal cancer, HER2 positive patients. That priority review should be hopefully wrapping up soon. We have a confirmatory trial also underway for the similar population, but in the first-line metastatic colorectal cancer setting. Those of you that have been following the company for a while know that we're studying Tukysa also in combination with Kadcyla, which is an ADC, in second-line plus metastatic breast cancer. We hope to have data for you in the first half 2023, and we're actively exploring combinations with other ADCs, such as ENHERTU and one of our products called DV. Last but not least is a basket trial that is expected to read out in the first half of 2023. Last but not least, in terms of our marketed portfolio is our product, TIVDAK. Towards the end of the year, we got NCCN became an NCCN preferred regimen for the treatment in second-line plus recurrent or metastatic cervical cancer. The product is growing nicely. We have work underway in terms of a confirmatory trial, with top line data expected by year-end 2023, and doing work with different dosing regimens to further confirm activity in head and neck cancer and plan a route forward there as well as the first-line cervical cancer setting. You can see I went through four marketed brands. Each of them is a mouthful because we have so many ongoing programs, and that justifies the potential to expand these brands strongly over the next couple of years. Now, the second area I mentioned in terms of a pillar of our strategy is the idea and the process by which we prioritize development of the most transformative assets. We thought about those assets in a couple of ways. First, do they combine well with, When they're ADCs, do they combine well with vedotin? Some of you may be aware there's been quite a bit of data now generated to show that vedotin ADCs combine with anti-PD-1s, there's an amplification effect through immunogenic cell death. Initially, people thought that this might have been something just specific to ADCETRIS. This has now been demonstrated across multiple products, including TIVDAK, Padcev, and another product called DV. We actually have 9 combination trials underway exploring this particularly strong, what I consider synergistic effect. The second part of our prioritization effort was to look at brands where we have global rights or near global rights, and where we had the opportunity to go into populations that were larger than those of our current brands. I'm going to take you now through three such opportunities, starting with a product that we call DV. DV is moving forward in urothelial cancer. You'll recall we licensed this in from a company called RemeGen. We have global rights for this product. The bladder cancer data, HER2-positive bladder cancer data is on the left. You see the very strong activity there. We continue our work as we were granted FDA Breakthrough designation for the brand with a Phase III KEYTRUDA combination trial in the first line of bladder cancer setting expected to initiate in 2023. In addition, we think there's an opportunity to put together and study DV with other agents, in particular, Tukysa, in HER2-low breast cancer patients, and that would be a second, potentially even larger opportunity for the brand. Beyond that, we can consider gastric cancer and other indications. Moving on to B6A, a new product targeting integrin beta-6. This particular antibody was designed by Seagen. It is engineered for high target selectivity, limiting binding to other integrins, which has been a problem for other attempts at targeting this particular receptor. This product is wholly owned and it's first in class. This means we would have the opportunity to launch this product potentially in big indications, and I'll show you there's some data on this slide we'll come back to in a second, and do that across multiple geographies, thus allowing more of the economics of this brand to flow directly to Seagen, potentially transforming this company. In front of you is the initial data that we showed earlier this year in the non-small cell lung cancer subset. These patients have failed three and a half lines of therapy on average. That means they failed anti-PD-1s, they failed chemotherapeutics, without yet optimizing the dose or regimen. You can see pretty striking response rates for this particular product. We expect that during the course of this year, we will be able to show more data, in particular the durability data associated with this product, and that will help inform the way forward into potentially into registration trials for this product in one or more tumor types. Last but not least, we have a product called SGN-B7H4. We believe this product, based upon the expression of B7-H4, has potential utility in breast cancer, endometrial cancer, and ovarian cancer. Once again, we have full global rights, and we will present initial data mid 2023. For each of the 3 products I've just showed you, think about large potential indications, full global rights, economics flowing to Seagen, which would be a transformative event for our company. Putting that all together, looking at our clinical pipeline, we prioritize those assets which are most differentiated and provide the greatest potential. You can see on the left-hand side of the slide in green, those that are part of our ADC platform, and on the right-hand side of the screen, the other targeted modalities which we continue to develop. Last but not least, we continue to plan to innovate in ADC technologies. People have actually asked me things like, are ADCs done? Will there be more? Is there any room to grow and expand? Our belief is that there will be multiple waves of ADC products. The first wave contain products like ADCETRIS, Padcev, and TIVDAK, which are ours. Also Roche's Polivy, which uses our technology and provides a royalty back to our company. There is a fairly long series of wave 2 products that we have in development that you see on the right-hand side of the slide. These are very novel, creative approaches. Moving forward, our discovery organization is working on three waves in parallel. Some will take longer than others to be realized, starting with ADCs employing novel auristatin and camptothecin technologies, ADCs incorporating new cytotoxic and immunostimulatory payloads, last but not least, novel drug conjugate technologies employing other diverse mechanisms of action. All these are opportunities that we will invest in to continue to expand the number of ADCs in the marketplace to reach patients with more effective cancer medications. In addition, we're going to continue the work that we've done in the past to supplement our pipeline with complementary external assets that have transformative potential. I'll just take you through three examples here today. The first is in the area of 4-1BB bispecifics. The first one being a product using Pieris' Anticalin technology. That Phase I is now enrolling. In fact, I think the first patient may have been treated this week or even this morning. Second area that we're excited about are gamma delta T-cell bispecifics. We're targeting the first IND later this year. Last but not least, you'll recall, we signed a deal with Sanofi, and we're now announcing the first product from that ADC-focused deal, and this is a CEACAM5 ADC that will be data at a major medical congress later this year, and we're targeting an IND towards the end of 2023. I happen to believe that there are a large number of external opportunities available right now in biotech. There are quite a few startup companies that have been working over the last 5 years, in some cases, investing $hundreds of millions, with initial datasets that had hoped to be able to go to the public markets to raise more money and now are unable to. I believe Seagen is in a sweet spot in terms of being an excellent licensing partner with a great development and commercial engine, and we'd be a great partner to bring in selectively some of those novel products to further supplement our pipeline going forward. I also wanted to show you a completely different view of our portfolio. Maybe you could call through the through the lens of economic value generation. First, we have the four brands in the market, which I hopefully was able to convince you will be continuing to grow from all the great work we're doing. Transformational opportunities that are large in size and geography with economics flowing to us. The number of products that I've barely mentioned today, all of which will have potential upside value to our company, some of which will move over to the transformational opportunity bucket in the coming months and years. I'm not quite sure what a JPM presentation would be without at least one financial slide. I'm going to give that to you here. Through the Q3, we had $1.4 billion in revenue. You recall that during the Q3, we took up our sales estimates for the year, and I just want to leave you with the thought that we finished the year very strongly. On February the 15th, we will share full year results with you during our earnings call. During 2023, we are going to be very busy. This chart lays out for you what we believe are the most important data and regulatory milestones for 2023. Just to pick out a few. First of all, a potential FDA Accelerated Approval in first-line, metastatic, excuse me, bladder cancer, and that would be in cisplatin-eligible patients, with the PDUFA date in April. In the case of ADCETRIS, we would hope the FDA will put the overall survival data into our label, which will help ADCETRIS continue to grow nicely going forward. In terms of our pipeline, as I promised, the additional Phase I data, including the durability data for SGN-B6A, in the first half of 2023, then the initial Phase I data for SGN-B7H4 in the second half of 2023. Medium-sized company, fighting well above its weight. Lots of data during 2023. I suspect this will be a very exciting year. Overall, this is a company that is one of the very few that has merged from a platform co-company, startup company, whatever you might like to call it, to one that has now the skills and capabilities to discover drugs, develop drugs and launch drugs now on a bigger footprint. Very large clinical pipeline, which we hope to further supplement both from our own ADC discoveries as well as our in-licensing activities. I believe, a number of the products are transformative in nature, and they could radically change this company and make it still stronger as we work to build an oncology leader. With that, I want to thank you for being here today. I want to call my team up to the stage, and we're going to take your questions. Okay. Great. As a reminder, if you want to ask a question, feel free to raise your hand. Someone will bring you a mic. If you want to ask one electronically, you can do that too. Let me introduce them before. Yeah ... dive right in because I failed to do that. On my far left is Todd Simpson. He's our Chief Financial Officer. He's been with the company quite some time, and he can regale you with stories about the startup of Seagen and to where we are today. Directly to his right is Charles Romp. He's our U.S. Chief Commercial Officer. To my left is Roger Dansey. Roger is President of R&D. With that, Jess, it's back to you. Great. One question we've got heading into the path of frontline Padcev is, Could the FDA wait and want to see the controlled study? Are they going to approve this product on single-arm data? Let me start, then I'll hand it over to Roger. I mean, they did just grant us a date in April. That's generally a good sign. The other thing I mentioned in the presentation is that the confirmatory trial is fully enrolled. Usually, that's one of the questions that the agency always asks is, "Will the drug company be able to get that confirmatory trial off the ground in a good way?" Do you have any thoughts of? No. Roger? Yeah. No. Yeah, so I think it's a great question. The unmet need in cisplatin-eligible frontline bladder cancer is high. There are therapies available, but there is still a significant need. The data package that we presented to the agency that we have now filed is very strong. It's not like we've done this experiment once, we've done it twice with both Cohort A and Cohort K, so it's pretty reproducible. Padcev is already an approved product in the disease. As David said, the confirmatory trial is well advanced, such that there's an element of de-risking there. The agency doesn't have to wait too long for that approval. In the end, it is the FDA's call, but we think as we are now, we're about as strongly positioned as we can be from our side to garner an Accelerated Approval. Hello. I'm June. We have incubated a lot of successful biotech companies, and, the way I look at your team is extraordinary. Very experienced in any given way. All companies need to look at beyond 10 years, 20 years. How you transform, like, in very good safe hands like your team, until next 15 years. Yeah. I think the question. First of all, thank you for the compliments. I think the question is okay you've gotten to this place and the team in place has launched 4 drugs and has put a a great development portfolio together and demonstrated real capabilities. How do you make sure that the next 10 or 15 years are going to be at least as good? I actually think they're going to be better. Part of what one needs to do is deploy the learnings from the beginning and get better and better at drug development and commercialization. We have that in place. Second is to learn from, for example, other organizations, what to do right and what not to do right as one tries to scale a company. You will see that we will spend some of our energy scaling certain systems, for example, better IT systems and the like, so we can handle a still broader portfolio. Third, is just not to get arrogant, and nor complacent. It's to make sure we continue to realize that biology is challenging, things are always changing, there are new competitors, and one needs to remain agile and adjust strategy as one goes along. It's not a guaranteed formula for success, but I think having the foundation we had does set us up well for that future success. Perhaps I could add a comment as well. I mean, as David presented on the slide, our discovery group has a very, very long-term view as well as a short-term view. You can appreciate that we marketed products to existing products to near-term payload, variations, to then completely new approaches, all the way down to ideas that we are beginning to think about now. Those are all long-term plans that may take us 5, 10 years to get there, but the potential is enormous. just the ability to deliver something to a cell through an external delivery vehicle, whatever that vehicle is and whatever you're going to put in the cell, there are so many constructs that we can think about. We have a long-term view in research as well. I'll just one final thought. Again, it's all about people. To the extent that you are hiring people, develop them, developing them into leaders, teaching them how to perform well in high-performing teams, along with the not getting arrogant or complacent, I think that's ultimately what makes the difference. Okay, we have a question on the portal here. Feel free to keep them coming. I'm going to expand upon this because it's pretty short. It just says, "What's the venue for the beta six data?" Maybe we can expand a little bit on that and talk about, maybe not just the not just the venue, but kind of what your bigger plans are for that product. Do you want to speculate on when, where, how we might show them? I think we've given as much as we're comfortable in the slides. We're looking forward to presenting updated data towards the middle of the year. As I think David had mentioned, durability is key for all of these products. Plus we'll probably have an expanded dataset that we can share. We're highlighting SGN-B6A because we see real potential. It's not just lung cancer, it's head and neck cancer, it's esophageal cancer as well. We like the construct, we like the antibody, we like the targets. We are so attuned to the payload, we're optimizing the dose and schedule as we go. Obviously, in terms of like, what is the next decision point and what would our where would we make a call as to whether we're proceeding to a pivotal? That is entirely data dependent. Mm-hmm. We're hoping to be able to make important decisions on SGN-B6A in this calendar year. Gotcha. Another question like I get from investors is this company has been successful bringing multiple products through approval, but what about sort of financially as a company? How do you think about the path to getting the company to sustain profitability? Yeah. Yeah. This company could be profitable pretty soon if we wanted it to be. On the other hand, I just showed you a presentation where there's at least three transformative opportunities on that page. I believe that the company's previous strategy of driving top line growth and new drugs has paid off and will continue to pay off. My preference would be to, when we get profitable, to get very profitable, even if that pushes the date out a bit to make sure we fund these programs. That's probably the best I can do at this moment, 61 days into the job. Okay. Maybe just like a kind of a nearer term, step on that path of profitability, as we think about this padcev inflection. Mm-hmm. As you get frontline cis ineligible and then eligible, how much can you leverage your existing commercial infrastructure for that expanded launch versus how much will you need to kind of add additional investment? Hey, Charles, you want to take that? Yeah. Absolutely. We have built a comprehensive footprint in commercial. This is a marketplace that we've been in now for 3 years. Padcev is a standard of care in its current label. I think there's an opportunity to continue to work to gain efficiencies with the shared services that we have internally, market research, other sophisticated parts of the organization that we tap into for the launches that we've had. We will continue to work to make sure that we refine the best practices from the prior launches. We had three launches in 22 months of new entities. We're entering into a marketplace now where we have again, a familiar footprint in. I think there's efficiencies that can be leveraged in that situation. It's an exciting opportunity. It represents a substantial increase in the existing label that we have. Yeah, so just to add to that. The incremental costs are not very high to move into the first-line setting. Yeah. The population is probably about 2x the current population. When EV302, assuming EV302, the registration trial is positive and that gets into label, that would be also roughly a 2x of the current population. Mm-hmm. When you move into muscle and bone, basically you start talking about very large populations. That's why we're pretty excited about this brand. The fact that at least these indications are all in bladder cancer means the incremental cost of expanding commercial activities there is not very much. Can you maybe talk about what inning we're in of the HER2 headwinds to ENHERTU? Mm-hmm. How long that's going to take to kinda work through before patients maybe return to Tukysa? Yes, sure. Go ahead. the last two years have been dynamic in the breast cancer marketplace. We've seen the release of substantial data, which has been good for patients. We expect probably a return to patient flow that was probably 2 years ago into the third line, somewhere in the second half of 2023. I think at the end of the day, we have established Tukysa as an important option for patients, in particular those patients with brain metastases. It's a valued option in that place. That's where the majority of the use that we have is. In addition to that, we have some additional data that may be coming out in combination with Kadcyla. I think this will provide us an additional opportunity in third line with visceral Mets. The simplest way to put it will provide physicians with an and choice rather than an either/or choice like they have. Can you expand a little bit on that? Sure. That's something I've kind of been turning over in my head is kind of like what that data set's going to mean. I think it's two things. One, I think it will be reaffirming for the data that we have in brain metastases. I mean, we have a go-to product for that. We have included active brain Mets in our original trial. This trial will also include patients with brain metastases in it. I think there'll be a secondary validation that is there further entrenching the utilization associated with Tukysa in brain metastases. In addition to that, Kadcyla has moved down downstream as a result of the entry of ENHERTU into the second line, which is now being used, generally speaking, in a third line capacity. Physicians will have a choice when they go into third line, as it currently sits, to use Tukysa or Kadcyla. If this combination shows improvement, it will be an and decision. They will use both products. That includes patients that have visceral Mets as well. Mm-hmm. David, one of the slides you presented was just kinda talking about the future, and I think there were some years out into the future, in terms of where Seagen might go beyond kinda the ADCs that you've got today. I think one of the things on the slide was novel drug conjugate technologies, and there were a couple of other, sort of new areas. Can you give us some examples or expand a little bit about? Seagen, on what those areas could look like? You want to take a shot? I think that the details in that area are probably we'd rather keep confidential at this point. From the point of view, as I was trying to indicate earlier, that sort of five to 10 year lens is taking essentially novel all parts of an ADC and looking at what can we do in a novel, in a novel fashion. I think going any further is not necessarily in our best interest at this point. What I can say is we have pretty robust plans already with a long-term view of what could an ADC or an allied technology look like that will take us five years or longer to develop. Maybe switching to DV. How much data from RemeGen can you leverage to speed up your development in the U.S.? As a HER2-directed ADC, can you talk a bit about the differentiation from other HER2 ADCs that are out there? Sure, yeah. Yeah, that's a great question. Our colleagues, RemeGen, have generated data in China. DV is approved in China for both breast and gastric cancer. We've taken the view those data are important. They tell us what this product can do, but our development plans focus on generating data in the West. It's good that we have information like that. Obviously, any submission that we would put forward in the future would include anything that we have, but we're not necessarily looking to leverage data as either an efficacy package to an agency. We'll be generating our own data in Western populations. That second line trial is underway, correct? Of course, yes. We are actively enrolling in urothelial cancer under Breakthrough Therapy designation in an open-label IND in the U.S., looking at monotherapy of disitamab vedotin, in HER2, Both a HER2-positive, a traditional definition of HER2-positive, which would be amplified or overexpressed, but we're also interested in an analogous HER2-low population. We're looking at HER2 expression down to lower levels as well to understand whether DV has an efficacy signal there. All right. I think we're about out of time, so thank you. Great. Thank you. Thank you. Thank you. Thank you.