Good day, and thank you for standing by. Welcome to the Sesen Bio Quarter one 2021 Business Update Call. At this time, all participants are in listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star and then the number one on your telephone keypad. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker, Ms. Erin Clark, Vice President of Corporate Strategy and Investor Relations. Please go ahead. Thank you. Good morning, everyone. Welcome to our first quarter business update call. On today's call, we will discuss our operating results for the first quarter ended March 31st, 2021, as well as an update on the commercial readiness progress to- date ahead of our target PDUFA date of August 18th, 2021. Joining me on today's call are Dr. Thomas Cannell, President and Chief Executive Officer, Dr. Chad Myskiw, Executive Director of Supply Chain, and Monica Forbes, our Chief Financial Officer. Earlier this morning, we issued a press release outlining some of the highlights that will be covered on the call today. The press release and the slides to which we will refer are available in the investors section of the company's website at sesenbio.com. I would like to remind you that today's discussion will include forward-looking statements related to the company's current plans and expectations, which are subject to risks and uncertainties. Actual results may differ materially due to various factors, including those described in Sesen Bio's most recent annual report on Form 10-K, quarterly report on Form 10-Q, and other SEC filings. These statements represent Sesen Bio's views as of this call and should not be relied upon as of any future date. Sesen Bio undertakes no obligation to publicly update these forward-looking statements. With that, I will turn the call over to Tom. Tom? Thank you, Erin. Good morning, everyone. Thank you so much for calling in and participating in our business update today. Please turn to slide three, which is a summary of the three key takeaways for our call today. First, Vicinium has a unique and compelling value proposition, especially when it comes to its potential to improve patient outcomes while reducing overall healthcare costs. Second, we believe we have a clear regulatory path forward with potential approval in the U.S. in August of this year and in Europe in early 2022. Finally, given the substantial unmet need in bladder cancer and the highly differentiated clinical profile of Vicinium, we project a significant global commercial opportunity. Please turn to Slide 4. If you've been following us for a long time, like many of you have, you know we always start our presentation with the patient journey to make sure we are focused on realizing our mission to save and improve the lives of patients. It is important to understand the unmet medical need in bladder cancer through this lens, not only to understand why there is such a significant patient need for a product like Vicinium, but also to understand why we believe prescribing physicians will prefer Vicinium versus available agents. An important takeaway from this slide is that urologists play a key role guiding the patient through their journey. Most medical decisions, including treatment choice, will be decided by the patient and the urologist, and we'll talk about why that is important in a few minutes. Please turn to Slide 5. This shows our anticipated regulatory timeline for our four biggest global markets. We continue to make progress across each of these key regions. In the U.S., the team is laser focused on responding to information requests, site inspections, and preparing for the late-cycle meeting with the FDA in July. We continue to be encouraged by what we have found to be an engaging and collaborative review process. As you may recall, the late-cycle meeting was originally scheduled in June, but due to delays scheduling site visits outside the U.S. caused by the pandemic, we're now planning for that meeting in mid-July. You can see we remain on track for our target PDUFA date of August 18th, and our current plans are to begin promotion to physicians and patients upon potential approval in August with commercial product supply available in urology clinics by the fourth quarter. Given the market dynamics in this market, we would expect signs of early commercial success by mid 2022. In Europe, we achieved an important milestone with the conditional acceptance of our proprietary brand name, Vicinium. In addition, the EMA notified us that the MAA submission was found to be valid and that the review procedure has officially started with potential approval in early 2022. Next, in China, the IND was approved by the CDE, which triggers a milestone payment from our partner, Qilu Pharmaceutical. It also enables Qilu to conduct a proposed clinical trial to assess the efficacy and safety of Vicinium in patients in China, and we expect the first patient to be dosed in that trial next month. Finally, in the MENA region, we continue to work closely with our partner, Hikma Pharmaceuticals, to submit Marketing Authorization Applications in 2021 in key markets with the first wave of potential country approvals for Vicinium in the MENA region as early as 2022. Turning to Slide 6, just a reminder that while our planned trade names in the U.S. and Europe will be spelled slightly differently, they will both be pronounced the same, Vicinium. We would expect most countries outside the U.S. and Europe to utilize one of these two spellings. Turning to our brand strategy, we believe we are positioned to launch a best-in-class therapeutic that will improve patient outcomes while reducing overall healthcare costs. Given the differentiated value proposition of Vicinium, we expect that Vicinium will become the market leader in the non-muscle invasive bladder cancer market in late 2022 on a path to realize global peak sales of $1 billion-$3 billion. Turning to Slide 7, you can see a high-level view of our customer engagement strategy. We have identified about 300 national and regional key opinion leaders, or KOLs, where a very high level of engagement is warranted. For these customers, we'll deploy medical science liaisons with the full support of our medical affairs department. We'll also engage some of those KOLs as speakers at a variety of company-sponsored and independent conferences and programs. I want to mention our reimbursement support strategy. Vicinium is going to be a buy and bill product, and we will be selling directly into the urology clinic. Given this, it is critical that we have the right support to ensure clinics are reimbursed for Vicineum and that we provide helpful resources to patients as they go through the reimbursement process. From a sales force perspective, there are about 2,000 high-prescribing physicians our sales force will target. We recently announced a partnership with the leading contract sales organization, Syneos Health, who will provide logistical support in hiring and deployment of the sales force. The sales force will include 35 representatives across four geographic regions. This will enable reps to see each target on average a couple times a month with a very reasonable investment in terms of operating expense. Finally, there are also some high-prescribing physicians who are located in more rural locations and are harder to see, but it still makes sense to interact with them virtually. For targets located at these sites, we'll use inside sales reps to efficiently reach these prescribers. Overall, we are confident in our customer engagement strategy. Bladder cancer is a highly concentrated market, and we believe we have developed an approach which will lead to strong product uptake and sustainable growth. Please turn to Slide 8, which highlights the results of our market research of Vicineum relative to KEYTRUDA. When we show high prescribers of bladder cancer the profile for Vicineum and for KEYTRUDA, they say that they would choose Vicineum over 80% of the time because they view Vicineum to have an advantage in terms of safety, ease of integration into their clinical practice, and overall physician interest in using the product. Physicians have a very favorable brand image of KEYTRUDA, therefore, when physicians choose Vicinium over KEYTRUDA 80% of the time, that strongly positions us for a successful launch. With that, I'll hand the call over to Chad. Thanks, Tom. If everyone can please turn to Slide 9. Given the complexity of manufacturing biologics, we've purpose-built a very reliable and robust supply chain with world-class manufacturing partners. Our current supplier for drug substance is Fujifilm, and for drug product, Baxter. Both of these CMOs are industry leaders with a long history of manufacturing excellence and a strong regulatory track record with the FDA and other regulatory agencies. To strengthen our existing supply chain, we are currently transferring the Vicineum manufacturing process to Qilu Pharmaceutical, our partner in the Greater China region, to add them as an additional source of drug substance and drug product supply in the future. Qilu has a very large and experienced manufacturing team and already supplies commercial products to the U.S. We feel very good about bringing them on board. For third-party logistics and specialty distribution services, we are working with Cardinal Health in the U.S. Cardinal is one of the most well-respected and capable players in this industry. They have significant expertise in cold chain logistics and deep relationships with the uro-oncology community. We feel very confident we can leverage the experience of our supply chain partners to support a world-class launch of Vicineum. Turning to Slide 10 and the manufacturing process for Vicineum, which is produced via E. coli fermentation. The general approach of using microbial fermentation to manufacture recombinant proteins was pioneered by Genentech in the 1970s with insulin and continues to be widely used to manufacture peptides and small proteins such as antibody fragments. This system is very well understood and well-characterized. The specific process you see here is the proposed commercial process and was developed by Sesen Bio throughout clinical development and then transferred to Fujifilm and Baxter. Fujifilm manufactures the drug substance, so that is all the steps up to and including bulk drug substance formulation. This material is then sent to Baxter for drug product manufacturing, which is just a fill finish, and they will also do the labeling, secondary packaging, and serialization of the product. On Slide 11, we've highlighted what we see as some of the key advantages of the manufacturing process for Vicineum in comparison to other biologics and gene therapies. We're using microbial fermentation, a well-understood system that has and continues to be used to manufacture many recombinant proteins. The reliability of this system reduces the risk of manufacturing issues that can lead to supply shortages, and the non-muscle invasive bladder cancer space is very sensitive to supply issues given the ongoing BCG shortage and manufacturing problems with past products such as Valstar. Because microbial processes tend to be shorter and less complex than mammalian systems, and since we do not have any process intermediates or conjugation steps as you have with antibody drug conjugates, we expect to achieve a competitive cost of goods. Finally, having such strong manufacturing partners leads to a reliable and robust supply chain to support the launch of Vicineum. With that, I'll turn the call over to Monica. Thank you, Chad. Please turn to Slide 12 for a few financial highlights. We significantly strengthened our cash position in the first quarter, ending with approximately $110 million in cash and cash equivalents. We also saw a strong increase in stock price and market cap versus year-end 2020. With a strong balance sheet, we believe we are well-positioned to continue to build for a successful launch ahead of the potential approval of Vicineum in August of this year. Turning to Slide 13, as we prepare for commercial readiness in the U.S., we continue to manage our balance sheet through stage-gated investments, which are focused on our highest priority initiatives, such as supporting the regulatory process in the U.S. and Europe and the commercial launch of Vicineum in the U.S., illustrated by the dark blue bars We also continue to strategically raise capital to strengthen our cash position, as shown on the dark purple bars. I will remind you that given our strong cash position, as of April 1st, we shut down our ATM for April and May. We will reactivate the facility no sooner than June, and will continue to operate it on a periodic basis consistent with our historical practice, with the goal of minimizing dilution and decreasing the need to do a large dilutive financing event. With that, I will turn the call back to Tom. Tom? Thank you, Monica. Please turn to Slide 14, which is a summary of the three key takeaways from our call today. First, Vicineum has a unique and compelling value proposition, especially when it comes to its potential to improve patient outcomes while reducing overall healthcare costs. Second, we believe we have a clear regulatory path forward in both the U.S. and Europe. We continue to work closely with the regulatory agencies as we approach upcoming milestones. Finally, given the substantial unmet need in bladder cancer and the highly differentiated clinical profile of Vicineum, we project a significant global commercial opportunity. With that, we will open up for questions. Ruby? Thank you. To ask a question you need to press star and then the number one on your telephone keypad. Again that's star and then the number one on you telephone keypad. If you want to withdraw your question please press the pound key. Please standby while we compile the question and answer roster. Your first question comes from the line of John Newman from Canaccord. Your line is open, you can ask your question. John? You might have us on mute, John. Hi, can you hear me? Yep, I can hear you. Hi, Tom. Sorry about that. No problem. Tom, good morning, and thanks for all the updates. Tom, I just wondered if you could comment a bit on the design of the phase III studies that were run for Vicineum. The reason I'm asking is whether you would expect full approval or accelerated approval, given that when I look back at the guidance, it seemed, to me at least, like the design for your studies, I think was consistent with full approval. Obviously, that'll be up to the FDA, but just curious if you could comment there. Yeah. Thanks, John. It's a great question. Obviously, it's very topical because last week the FDA had ODAC meetings or advisory committee meetings discussing the accelerated approval pathway. You're right. In the February 2018 guidance, the FDA says that for carcinoma in situ, you can conduct a single-arm trial, and that you would be eligible for either full or accelerated approval, and they said, we'll make that call during the review process. We had our first pre-BLA meeting in June 2019, and again, there was a lot of good news there. The FDA gave two pieces of guidance. They said, we expect that you'll need an advisory committee meeting, and we'll expect that you're on an accelerated, not a full approval pathway, which means you'll need a confirmatory trial. That's how we've been kind of planning things, and that was the guidance we gave at that time. Obviously, we feel like as the data come together, it just keeps looking better and better. It was really good news in February of this year when the FDA said, oh, it appears that an AdCom will not be required, and we don't have one scheduled. What they haven't weighed in on yet, and we probably won't learn until right around the PDUFA date, right around August 18th, is whether they'll require an accelerated approval, which means a confirmatory trial, which was their previous guidance, or whether they're prepared to give full approval. Still our guidance is the same based on what the FDA told us during the pre-BLA meeting. Our guidance is that we expect accelerated approval, and we are ready. We have a protocol written. We're ready for a confirmatory trial if that's their decision. That would be great news. That would be a great event for us is to get that accelerated approval in August. There is the chance of the upside scenario where we actually get full approval, and so that's something we'll all just be watching for as we approach the PDUFA date. Did you have a follow-up question, John? I did, actually. It's interesting. I'm just wondering, just in your view, what will change in terms of the views on the company once Vicineum hits the market? Just curious as to what investors might learn over time when Vicineum, or if Vicineum is approved and in the market that could sort of, in your opinion, kind of change your views on the trajectory of Sesen. Yeah. It's a good question, and we get that a lot. I will, since this is all about forward-looking statements, remind everyone of Slide 2, especially the risks and uncertainties. We've guided that we believe based on the comprehensive Monte Carlo simulation, that there's an 80% probability of Vicineum having peak sales of $1 billion-$3 billion. You can use whatever PE ratios you want, but if we're right, the company value has the potential to be much higher than our current market cap, right? If that happens, John, then I think the market will have learned and really come to understand three things. First of all, I'd say it's the powerful role of the urologist, which I alluded to talking about the patient journey, and then the clear understanding of the three key drivers that motivate them, all of which play in the favor, I think, of Vicineum. First, urologists make decisions based on medical drivers, especially the benefit-risk profile. They're looking for a product that delivers the best efficacy with the least safety risk. We believe we're the clear winner versus KEYTRUDA in that regard because we have comparable efficacy and a much better safety profile. Second of all, urologists make decisions on emotional drivers. It's well understood. They are very loyal and committed to their patient. They do not want to refer to another doctor like medical oncology because they're concerned that other specialties do not adequately understand bladder cancer. If the urologist chooses docetaxel, they get to keep treating the patient. If they choose KEYTRUDA, someone else probably treats their patient. We think the emotional drivers are a big factor that the market will come to understand. Finally, it's the business drivers. It's important to understand urology clinics make their money through treatment rooms and diagnostic tests. If that urologist chooses docetaxel, their urology clinic gets to keep treating the patient and running diagnostic tests every three months, including cytology, cystoscopy, biopsy. On the other hand, if they choose KEYTRUDA, the academic medical center or the medical oncology practice derives that business benefit. Again, to this point, I believe that urologists are always going to do the best thing for the patient and always make their decision based on medicine first. If you can choose the best product for the patient, the treatment adoption will be accelerated if that is a more profitable approach for the clinic and the doctor. I think there's a lot for the market to understand about the urologist and the medical, emotional, and business drivers that we think will really shape the treatment of non-muscle invasive bladder cancer. The second thing, John, I think is, and we've talked about this, there's a good backup slide on this, is the virtuous cycle that's created when you have the advocacy of all three customer segments, patients, payers, and physicians, a nd this is pretty rare for new product launches to have advocacy from all three segments, and here's why that's important. The stronger the advocacy from patients and their families, and the more they ask for a new product, the more likely the doctor is to prescribe that product. That phenomenon has been well documented. The stronger the advocacy of physicians and key opinion leaders, the more likely that payers will add the product to formulary and reimburse the product fully. Remember, it's mostly physicians that sit on these managed care P&T committees, that physician view really matters. The better the reimbursement is from payer, the lower the out-of-pocket cost for patients and the better the patient access to therapy. I think when all three groups are advocating, the stronger the feedback loop is, and that can drive, I think, very strong early and sustainable uptake. That's the second phenomenon, I think, is the interplay and the virtuous cycle between the different customer segments, and I think that's fairly unique in our situation. Finally, I think something that people aren't completely paying attention to yet is just how lucky we are to have KEYTRUDA as our primary competitor. KEYTRUDA is arguably the most important oncology product in the modern era. As you know well, John, they grew 30% last year with sales last year of $14.4 billion. I haven't seen your projections, but many analysts project it to surpass $20 billion and become the best-selling pharmaceutical product of all time. I believe it has right now the best brand image of any oncology product. KEYTRUDA's indicated for 19 types of cancer, and in one of those, NMIBC, we believe we're better than them. We believe we will surpass KEYTRUDA, become the market leader in NMIBC. I think as you know, real strength of our company, I think is the commercial and marketing expertise. When you beat the dominant market leader in one single area, it has a transformational effect on your brand image and the value of your company. From a commercial marketing perspective, it's a very important phenomenon. Anyway, we think we've got the best situation for a new product launch to be positioned against one of the most important oncology products of all time. I believe by the time we potentially launch our next indication potentially for head and neck cancer, that that'll be a whole different ballgame. Basically, what should investors be watching for? I think watch the role of urologists and what motivates them, watch the virtuous cycle between physicians, payers, and patients, and watch the market share battle between KEYTRUDA and docetaxel. Obviously, after August, we'll structure our presentation so that's easy to follow. Any follow-up on that, John? No, that's great. Thank you, Tom. Thanks, John. Thank you. Your next question comes from the line of Roger Song from Jefferies. Your line is open. You can ask your question. Great. Thank you, Tom, taking the question. Maybe just a quick follow up on John's question earlier. Obviously, if you can get a full approval in August, there will be a real kind of upside. Just tell us a little bit about the logistics, because as far as I know, I think from the last guidance, you may need to start the confirmatory study before the PDUFA date or maybe just to finalize the protocol. Probably you already get some additional kind of guidance from FDA if you need a confirmatory study. Obviously, you are having back and forth with the FDA right now. Just tell us a little bit, what should we expect? What is going to happen before the approval decision in terms of the confirmatory study, your site inspection, and the late-cycle meetings? Yeah, that's a great question. I think, as I've said before, it's definitely the FDA's preference that you launch your confirmatory trial right around the time of approval. We had a Type C meeting with the FDA. We agreed on the protocol synopsis and the overall approach. As we've talked about, we plan on targeting the less than adequate BCG population. That's patients that have had only one to six instillations. We will be ready to go. We have a team to put together, a clinical trial oversight team, and as we move through the process, if it seems increasingly likely that it's accelerated approval we'll be ready in the third quarter to launch a study. I will say, even if they don't require a confirmatory trial, it's something I want to do anyway, is to do that clinical trial in the less than adequate BCG population. We have data to suggest that the Vicineum is even more effective in patients that have had less exposure to BCG. It also puts us on a path toward hopefully someday first-line therapy, with or without combination therapy, depending on how we design the trial. Even if we don't need the confirmatory trial, we do intend to do a study in that patient population. That's the thinking right now, Roger. What I would say is, if we learn more at the late-cycle meeting, which is mid-July, then obviously we'll disclose that and we'll come out and make sure that investors know what the update is there. Do you have a follow-up, Roger? Yeah, I do have one follow-up. First of all, thanks for the color. Thanks. My next question is related to the financials, understanding your contracting CSO to do the sales. Just tell us a little bit about what is the level of the ramp-up in terms of the SG&A, and what is the pace, and since you're having $110 million in the bank, and what is the current cash runway you will guide us? Yeah. That's great. Well, I'll just talk about the ramp of the contract sales organization. I'll let Monica speak to what we think the cost is per annum for a contract sales organization of that size. We've said publicly it's 35 representatives and up to 10 reimbursement specialists. We've got the national sales director hired as well as the VP of sales. We're in the process and close to finalizing all the region sales directors, and then we're getting ready to go with the representative interviews and then training. All of that will happen throughout the spring in getting those representatives to be ready to be out there in August. Same thing with the reimbursement specialists and the concierge call center that we'll set up to support patients through the process. We have a lot of experience with Syneos. I've worked with them in the past. This is really their area of expertise, is they can find talent, have a very expeditious recruiting process, and then train those representatives, and they're going to be ready to go. That's how we're thinking about the rollout of the contract sales organization. Monica, I'll just let you talk about OpEx in regard to that. Sure. Thanks, Tom. Hey, Roger. We haven't guided specifically on what our cash burn will be once we stand up the sales force and build the full commercial team. We have said with regards to the CSO and the number of representatives that we will hire, we expect roughly $10 million-$15 million on an annual basis for that part of the commercial team. I think you also referred to our cash balance, and just with regards to the cash balance of $110 million at the end of the first quarter, we do expect that, again although we're not guiding on cash burn, we do expect the $110 million to be sufficient to fund operations through the fourth quarter of this year. Great. Awesome. Thank you. That's all from me. Thanks, Roger. Thank you. Your next question comes from the line of Arthur He from H.C. Wainwright. Sir, your line is open. You can ask your question. Hey, good morning, everyone. Thanks for taking my question. This is Arthur for RK. I just had one question regarding the manufacturing part. As we know, there's an industry-wide backlog for FDA conduct the on-site inspection. I just wonder, such kind of on-site inspection also required for the approval for Vicineum, and how the communication between you guys and the agents regarding that issue? Thank you. Yeah. I'll just answer it at a high level, and then I'll check with Chad to see if he wants to add anything on top of it. Again, as the FDA prepares for the late cycle meeting in mid-July, obviously they're doing their clinical and their manufacturing site inspections. As we mentioned, because of the pandemic, which again, there was just something in the Pink Sheets that there's been delays across the board in the FDA getting out. We do feel confident that they'll have all of those wrapped up in time so that we can have a good, really productive late cycle meeting in July and still on a pathway for potential approval in August of this year. Again, you can imagine the most important of those site inspections would be at Fujifilm, which is our bulk drug substance manufacturer, that's where probably 90% of the overall complexity and the work is around manufacturing. We feel very confident. Fujifilm was with us when we had the Type B meeting with the FDA in terms of demonstrating analytical comparability, and they're a world-class manufacturer with a real good track record with the FDA and from a regulatory perspective. We feel good for us about how that's going, recognizing these site inspections have been a real challenge for the agency since the pandemic hit. Chad, anything you wanted to add to that? No, Tom, I think you answered that very well. Great. Thanks. RK, did you have another question or a follow-up? No, thank you. Thank you for the color. Thanks. Thanks, RK. Thank you. At this time, there are no further questions on queue. I would now like to hand the conference over to our President and CEO, Dr. Thomas Cannell. Thank you, Ruby, thank you everyone for your good questions today and your interest in Sesen Bio. I'd also like to take this time to thank our employees. We only have roughly 30 employees, and they're just doing Herculean work in bringing this product to market and being prepared for manufacturing and supply chain and all the commercial prep that's underway. Just want to thank the team for everything they're doing. It's just an outstanding effort, and they're working so well. You will be hearing again from us soon. Thank you again to all of our investors for your interest, and please stay safe and have a good week. With that concludes our call for today. Thank you all very much. Ruby, I'll hand it back to you. Thank you. This concludes today's conference call. You may now disconnect.