Good morning, everyone. Thank you for standing by, and welcome to the Atara Biotherapeutics conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please be advised that today's call is being recorded. I'd now like to hand the call over to Eric Hyllengren, Vice President of Investor Relations and Finance at Atara Biotherapeutics. Please go ahead, sir. Thank you, operator. Good morning, everyone, and welcome to Atara's Strategic Collaboration conference call. On today's call, members from the Atara executive team will discuss our recently announced strategic collaboration with Pierre Fabre. Earlier today, we issued a joint press release announcing that Atara and Pierre Fabre have entered into a strategic collaboration to commercialize Tab-cel. This press release and a summary slide about the collaboration are available in the Investors and Media section at atarabio.com. Joining me on today's call are Dr. Pascal Touchon, President and Chief Executive Officer, Utpal Koppikar, Chief Financial Officer, and Dr. Kristin Yarema, Chief Commercial Officer. We will begin with prepared comments from Pascal and then open up the call for your questions. We would like to remind listeners that during the call, the company's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the company's SEC filings. These statements are made as of today's date. The company undertakes no obligation to update these statements. Now I'd like to turn the call over to Pascal. Pascal? Thank you, Eric, and thank you all for joining us this morning. It is with great pleasure that I announce Atara and Pierre Fabre have entered into an exclusive strategic collaboration to commercialize tabelecleucel or Tab-cel. After a very competitive process, Pierre Fabre has been selected as the right partner to commercialize Tab-cel for EBV positive cancers in Europe and select emerging markets in the Middle East, Africa, Eastern Europe, and Central Asia. Pierre Fabre brings significant oncology commercialization capabilities in the territory. Tab-cel will benefit from the existing Pierre Fabre integrated oncology business unit while leveraging their network in bone marrow transplant. They also have a successful track record of partnerships and have been very interested in growing their business to include innovative immunotherapies such as Tab-cel, the most advanced allogeneic off-the-shelf T-cell therapy. Under the terms of the agreement, Atara will receive $45 million upfront and up to approximately $320 million in regulatory and sales milestones, plus significant double-digit tiered royalty as a percentage of net sales. Pierre Fabre will lead all commercialization and distribution activities in its territory, as well as medical and regulatory activities after the anticipated MAA approval in Europe. Atara will continue to be responsible for the pivotal ALLELE study in PTLD, as well as submitting the European Marketing Authorisation Application, MAA, for Tab-cel in patients with EBV positive PTLD. Tab-cel remains on track for European MAA filing in November 2021 with accelerated assessment, which could lead to an approval in the second half of 2022, as we have previously noted. Atara will also remain responsible for the phase II multi-cohort study, which is studying Tab-cel in six additional patient populations with the goal of label expansion in EBV-positive driven cancer. As part of the transaction, Atara will also provide manufacturing services for Tab-cel to be paid by Pierre Fabre. From an investment standpoint for Atara, this partnership maximizes the commercial potential value for Tab-cel in the collaboration territory. Atara will avoid the cost and complexity associated with building infrastructure outside of the U.S., giving us the opportunity to tighten our focus on strong launch execution in the U.S. market for Tab-cel. It is also worth noting that Atara also retained full commercialization rights to Tab-cel in North America, Asia-Pacific, and Latin America. In conclusion, together with our partner, Pierre Fabre, Atara is very excited to hopefully soon bring the first allogeneic off-the-shelf T-cell therapy to patients in need. I would like to thank very much our staff at Atara and our collaborators who are working hard to achieve this goal. I now turn the call back to the operator to begin the Q&A portion of the call. Operator? Thank you. We will now be conducting the question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, while we poll for your questions. Our first questions come from the line of Salim Syed with Mizuho. Please proceed with your questions. Great. Good morning, guys. Congratulations on the collaboration. Pascal, I just had a question, or I guess I just wanted additional color around the milestones, if that was at all possible here. Can you split out for us how much of the $320 million is regulatory versus sales-based milestones? Are any of these milestones, and I apologize for this multi-part here, but are these milestones related at all to the U.S. approval of Tab-cel? Curious what the thresholds were around the sales part of the sales-based milestones. Thank you. Thank you for your question, Salim, and for your thanks there. At this stage, we are not disclosing much more on the milestones. It's a regulatory and sales milestone. I think the main objectives of Atara Biotherapeutics, now with our partner, Pierre Fabre, is to file and obtain approval in EU and U.K., which is linked with EU, in the current process for the [EMA], and that's our main objective. We are very focused on getting to that point, filing and getting approval. Now, we are not disclosing anything on the type of sales milestone we're talking about. Suffice to say that we are very excited to work with them because Pierre Fabre has not only this presence in Europe, which we were looking for, as well as real knowledge of the oncology centers, as well as transplant centers in Europe, but also beyond Europe in these emerging markets where they have a very solid presence and a good track record of launching oncology product there, and also managing Busilvex as a product used in transplants. They know very well transplant centers. We are not giving any more details on the milestone, on the sales milestone in terms of what type of threshold that we're talking about there. Understood. Thanks so much. Thank you. Our next questions come from the line of Tessa Romero with JPMorgan. Please proceed with your questions. Hey, guys. Good morning. Congrats on the agreement here. Two from us. Our first one is really, we've talked at length about the size of the relapsed/refractory EBV-positive PTLD market here in the U.S. What are the sort of the key similarities and differences we should be thinking about in terms of the U.S. versus the EU market? That's my first question. Maybe I'll just turn it over to you, and then I have one quick follow-up. Well, thank you for your question. We have with us Kristin Yarema, our Chief Commercial Officer. Kristin, do you want to address that question? Sure. Thank you for the question. I think the great news is that EBV positive PTLD and other EBV-driven diseases are really well known and recognized in Europe. The transplant centers and treatment centers are very well known. The disease is recognized as very severe with a high unmet need, and HCPs are really in search of new options to treat these patients. The outlook, I think, in Europe is quite good. For example, a number of guidelines already include cytotoxic T lymphocytes as possible treatments. I think there are a lot of very nice similarities between the European market and the U.S. market. Yeah, I will add to that we have already experienced in Europe through our clinical trial and compassionate use program. We have treated a number of patients in both type of program over the last few years. We have been able to work in a very collaborative way with these centers in different countries in Europe and be able to deliver within just a few days the product from the U.S. to Europe there. From a market point of view, there are a lot of similarities and no major difference there. We have experience now in both in terms of clinical trials and compassionate use, which is going to be very useful for partnership and the preparation of the commercial launch. Great. Thanks so much for taking our question. I actually think you answered both parts of my question, so thanks so much. Thank you, Tessa. Thank you. Our next questions come from the line of [Phil Nadeau] with Cowen and Company. Please proceed with your questions. Good morning. Congratulations on the deal, thanks for taking our questions. First, one question on the economics. You mentioned that you get paid for the manufacturing services, but there's also the two double-digit royalty. Are the manufacturing payments incorporated in the double-digit royalty, or are those payments in addition to the royalty? Yeah, we're not commenting on that, but I think at this stage, we can say that these are two different aspects of the financial of the deal. Great. I guess second question is a more broad one. You mentioned that this was a competitive process. Can you talk a bit more about what differentiated Pierre Fabre from the competition? What in particular made you go with them or induced you to go with them versus maybe some of the other options that you had? Different aspects are there that made us select Pierre Fabre. There is aspects related to the experience and expertise. What we like with them is that they are used to partnership with U.S. biotech. They have been very successful in two recent partnership in launching in Europe and some other markets, innovations coming from U.S. biotech. They have this practice, this habit, this track record there, which we find extremely interesting. The other aspect is not only they have this integrated business unit in oncology, and they're really focused on oncology in their pharma business and doing oncology only, but they have also this experience with transplant centers. They are very well connected to many transplant centers, in fact, all of them across the Europe and various other countries with their more than 10 years experience with Busilvex, which is used in the conditioning for allo transplants. They know very well the allo-HSCT transplantors and what they are doing, where they are working, what type of patients do they have, and so on. That was an additional interest for us in terms of their experience and expertise. Of course, they were bringing financials that were competitive, but beyond that, the level of motivation to the highest level of the company, I had many discussions with the CEO, [Éric Ducournau], and clearly it was something that was supported by the full company. When you see this level of motivation, we know it's a good start for this type of collaboration. They're extremely excited, very motivated. They have the expertise and experience that we need, and we believe that they are the best partner for us. Great. Thanks for taking our question. Does that answer your question? Yeah. That's very helpful. Thank you. Thank you. Our next questions come from the line of Jonathan Miller with Evercore ISI. Please proceed with your questions. Hey, guys. Thanks so much for taking the question. I'll join everybody else in congratulating you on the deal. I have a question on your current manufacturing capacity. Any plans you have to ramp that, especially given you're going to continue being responsible for global manufacturing. Beyond your capacity to deliver on the product, I wonder what your plans are currently in Asia, given that you've retained that market as well. No. Thank you for your question, [Jon]. To the first question, we are in fact more than ramping a capacity. We are building inventory. We are an allogeneic cell therapy company. There is a huge difference that sometimes is neglected regarding the difference between autologous and allogeneic. When you are in autologous cell therapy, you need to have capacity at the time of demand, and that's why you need to build a significant capacity before you launch. For us, it's very different. We have enough capacity to make campaigns of manufacturing to make inventory of our allogeneic off-the-shelf product. We've said in the past that we have made inventory already for the clinical trial, but also for the commercial launch in terms of preparing this type of inventory and having, as you know, this aspect of comparability being, we believe, proven between the commercial process version and the pivotal process version. It's all about building inventory. We've already built a significant inventory for the launch, and we're going to continue to build that to be ready at launch time to cover a very large percentage of the population around the 90%-95% level. That's for the manufacturing. In terms of the plant in Asia, we've decided at this stage to focus on the U.S. and Europe because we have so many things to do to create value at Atara, that we didn't want to be disturbed in having to develop specific studies for Asia. As you know, many countries in Asia, China, Japan, Korea, and others, are asking for clinical studies done locally, in the local population there. We thought it was not the right time for us to do that. Right now, we want to focus on the U.S. BLA and on the European MAA, and we want to keep that possibility to work and partner in Asia at a later stage. Does it answer your question, [Jon]? Absolutely. Thanks so much. Thank you. Our next questions come from the line of Matt Phipps with William Blair. Please proceed with your questions. Morning. Thanks for taking my question. Congrats on this deal. Just curious, you guys will fund the phase III here to completion and then also the ongoing phase II multi-cohort study. Will Pierre Fabre share any development costs for any additional indications or perhaps clinical work to move into earlier lines of PTLD patients? Yes. Thank you for your question, Matt. We are continuing the study, and that makes sense because we are running these studies across continents between U.S., Europe, Australia type of clinical trial sites there. In terms of new studies and new indication, we will discuss with our partner there. They certainly have demonstrated, and that's another reason we were interested in working with them, a keen interest of potentially developing Tab-cel beyond our current regulatory pivotal studies, both the phase III ALLELE study as well as the multi-cohort. There will be discussion, and there have been discussion around potential new type of work with Tab-cel. Again, at this stage, we want to focus and to be able to deliver on the expectations regarding first indication, EBV-positive PTLD, and then of course the additional indication through label extension with our phase II multi-cohort study. Great. Thanks. Yep. You're welcome. Thank you. Our next questions come from the line of Salveen Richter with Goldman Sachs. Please proceed with your questions. Hey, good morning, and thank you for taking our question. This is Elizabeth on for Salveen. Just more broadly, could you comment on Atara's strategy for in-house commercialization versus choosing to work with an external partner? Thank you. Well, thank you for your question. We've been clear that we will do partnership when we think is in the best interest of Atara, and we want to make sure here that we focus on, especially from a commercial point of view, first product, Tab-cel, on a very strong execution of commercial launch in the U.S. Atara internally is really focused on the U.S. launch following filing and, of course, approval, hopefully. We have built a team already. Kristin Yarema, who is here, has been able to build a team. We have a new GM, a General Manager for the U.S., who joined us recently, Stephane Berthier, with significant experience in launching products in the U.S. We're really investing and focusing on the U.S. launch. The reason we decided to have a partner ex-U.S. and right now in Europe and a number of emerging markets, is really that we can avoid the cost and complexity of having to build the commercial infrastructure in that type of territory. We have a partner that is already there, already successful, very keen and very motivated to launch successfully Tab-cel in this territory. That's the current strategy in terms of commercial footprint for Atara. We've also said that in the future, we will look at that product by product, asset by asset. Right now, right there, in terms of Tab-cel, we are really focusing on the U.S. launch. Does it answer your question? Yes. Thank you. Thank you. Our next question has come from the line of Tony Butler with ROTH Capital. Please proceed with your questions. Good morning, Pascal. Thanks very much. Would you be able to answer, this is back to manufacturing, when a patient in Europe is enrolled or treated, the question is, does Pierre Fabre actually pay for the drug at that point, or do they actually get invoiced in arrears? It's really a question on timing and when you're able to get payment just for manufacturing. Forget about the royalty payment. Thank you for answering the question. Appreciate it. Yeah. No, thank you, Tony, for your question. We have not disclosed details there, but suffice to say that the way we're working today is that for clinical trials, and I'll elaborate on the commercial situation, is that when a patient is identified in Europe, we receive the HLA type of that patient from medical department. We find the right cell line for that patient, then that particular product is being shipped to Europe for that patient to be treated in its institution. That's a process that takes usually three to four days, and that's very effective there. The difference when you have a partner there that is taking over, especially regulatory and of course, clinical aspect there, is that you need to have a QP release in Europe done by the partner. We're getting organized for that after we get the approval, of course, because right now it's us dealing with this, and we have had an organization there for some time to be able to deal with QP release in Europe. That will be transferred to Pierre Fabre, and they will be able to release the product in Europe there. Once the product has been shipped and released, that's a product that is basically controlled by Pierre Fabre in terms of the sale of the product to the institution. That's where there will be, of course, invoicing of the product by them. Pascal, that's great. Does it answer your question? Appreciate the color. Yes, sir, it does. Appreciate it. Thank you. Our next question has come from the line of [Ben Burnett] with Stifel. Please proceed with your questions. Hey, thanks very much, and congrats on the deal. Just two quick ones for me. I guess first, just on the next Tab-cel disclosure, I think you had mentioned that there might be some data at a meeting. I guess when can we expect a detailed update and any more clarity there, and I guess what kind of data should we expect to get? Yeah, I would refer back to what we say during August call, Ben, which is that we are in regular discussion with the FDA. We have asked for Type B meeting, one on clinical, one on CMC front. Following this Type B meeting, we hope to be able to have a pre-BLA meeting and then a filing in Q1 2022. That's for the U.S. For Europe, we've cleared all the gates, recently we announced that we were granted accelerated assessment status for Tab-cel in Europe, we say that we plan and we confirm that guidance this morning that we plan to file our MAA in Europe in November 2021. The last aspect is related to the ALLELE study data, where we said in August that we are planning to present this data at an appropriate congress in Q4 2021. Just a summary, but I'm happy to answer any other question you may have there. Just a summary of where we are in terms of expectations for future communication on Tab-cel. Okay. That's fantastic. I think you kind of answered my next question, which was, have you guys had those Type B meetings yet? It sounds like that hasn't happened yet. We're not commenting on that. Okay. We just referring you back to the. I got it. Okay. August call. Yeah. Okay. Well, thank you very much. You're welcome. Thank you. Our next question has come from the line of Yigal Nochomovitz with Citigroup. Please proceed with your questions. Hi, Pascal and team. Thanks for taking the questions. Pascal, can you talk a bit about how the market size for EBV, PTLD in the Middle East, Africa, and other emerging markets compares to U.S. and Europe? Also, what are your plans for developing Tab-cel in Latin America? Thank you. Thank you for your question. In terms of the Middle East, we are not giving any particular guidance there. The reason Pierre Fabre was interested in Middle East, Africa, is because there are a number of very well-developed type of transplant centers there, and there are a lot of transplant patients. We know that some patients have been asking for the product. We delivered ourselves, for example, some Tab-cel in Israel, in a compassionate use. We know that there is a lot of needs in this region that could be covered. We don't have any particular detail on the size of the market there. We will hopefully be able to give more details once we get closer to the launch from that point of view. In Latin America, I think there are different type of countries, and that's coming back to the answer I made to the previous question on Asia. We want right now to focus on the U.S. and Europe in terms of regulatory process, the type of submission, the type of data. As you probably know, there are countries in Latin America that their own way, and for good reasons, their own way to look at the regulatory filing and what's needed there. We prefer to keep that for later. The main reason is we want to focus on getting the product filed and approved in the U.S. and in Europe. Does it answer your question, Yigal? Yeah. Thank you, Pascal. Thank you. There are no further questions at this time. With that does conclude today's teleconference. We do appreciate your participation. You may disconnect your lines at this time.