Collaboration

Oct 4, 2021

Slides

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. Please be advised that today's call is being recorded. I'd now like to hand the call over to Eric Heilinger, 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 Pierafaba 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 attarabio.com. Joining me on today's call are Doctor. Pascal Tushan, President and Chief Executive Officer Upal Kopikar, Chief Financial Officer and Doctor. Kristin Yarima, 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 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, and 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 announced Atara and Tier 5 have entered into an exclusive strategic collaboration to commercialize tabloqucel or tab cel. After a very competitive process, Peer Faber has been selected as the right partner to commercialize tapcel for EBV positive cancers in Europe and select emerging markets in the Middle East, Africa, Eastern Europe and Central Asia. LERFAB brings significant oncology commercialization capabilities in the territory. Fabcel will benefit from the existing Peerfab integrated oncology business unit, while leveraging their network in bone marrow transplants. They also have a successful track record of partnerships and have been very interested in growing their business to include innovative immunotherapies such as TapCel, the most advanced allogeneic of the shelf T cell therapy. Under the terms of the agreement, Atara will receive $45,000,000 upfront and up to approximately $320,000,000 in regulatory and sales milestones, plus significant double digit tiered royalties 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 Authorization Application, MAA for tab cel in patients with EBV positive PTLD. Tab cel remained on track for European MAA filing in November 2021 with accelerated assessment, which could lead to an approval in second half 2022 as we have previously noted. Atara will also remain responsible for the Phase 2 multi cohort study, which is studying tab cel in 6 additional patient population with the goal of label expansion in EBV positive driven cancer. As part of the transaction, Atara will also provide manufacturing services for TapCel to be paid by Pierre Fabre. From an investment standpoint for Atara, this partnership maximizes the commercial potential value for TapCel in the collaboration territory. Additionally, Atara will avoid the cost and complexity associated with building infrastructure outside of Europe of the U. S, sorry, giving us the opportunity to tighten our focus on strong Roche execution in the U. S. Market for TapCel. It is also worth noting that Atara also retained full commercialization rights to TapCel in North America, Asia Pacific and Latin America. In conclusion, together with our partner PFR, Atara is very excited to hopefully soon bring the first allogeneic of the share 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'll now turn the call back to the operator to begin the Q and A portion of the call. Operator? Thank you. We will now be conducting a question and answer 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 $320,000,000 is regulatory versus sales based milestones? And are any of these milestones and apologize for these, it's multipart here, but are these milestones related at all to the U. S. Approval of tab cel? And curious how what the thresholds were around the sales part of the sales based milestones? Thank you. Thank you for your questions, Salim, and for your thanks there. At this stage, we are not disclosing much more on the milestones. So it's a regulatory and sales milestone. I think the main objectives of Atara now with our partner, TFF, is to file and obtain approval in EU and UK, which is linked with EU in the current process through the EMA. And that's our main objective. And 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 Peerfab 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 the Silvex as a product using transplants. So they're not very well transplant centers. So we are not giving any more details on the milestone, on the sales milestone in terms of what type of pressure 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. 2 from us. Our first one is really, we've talked at length about the size of the relapsedrefractory 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. And then 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 Kristine Yarema, our Chief Commercial Officer. So Kristine, do you want to address that question? Sure. And thank you for the question. So, 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. So the outlook I think in Europe is quite good. For example, a number of guidelines already include cytotoxic T lymphocytes as possible treatment. So I think there are a lot of very nice similarities between the European market and the U. S. Market. Yes. And 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. And 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. So from a market point of view, there are a lot of similarities and no major difference there. And 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. Our next question has come from the line of Phil Nadeau with Cowen and Company. Please proceed with your questions. Good morning. Congratulations on the deal and thanks for taking our questions. First one question on the economics. You mentioned that you get paid for the manufacturing services, in addition to the royalty? In addition to the royalty? Yes. We're not commenting on that. But I think at this stage, we can say that these are 2 different aspects of the financial of the deal. Great. And then, 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 PureFibre 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? Yes. Different aspects there that made us select BFR. 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 into recent partnership in launching in Europe and some other markets innovations coming from U. S. Biotech. So 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, who have more than 10 years experience with Glycylvex, which is used in the conditioning for allo transplant. So they know very well the allo CT transplanters and what they are doing, where they are working, what type of patients do they have and so. So that was an additional interest for us in terms of their experience and expertise. And of course, they were bringing financial that were competitive. But beyond that, the level of motivation through the highest level of the company, I have many discussions with the CEO here in Duverno. And clearly, it was something that was supported by the full company. And when you see this level of motivation, we know it's a good start for this type of collaboration. So 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 my questions. Thanks for your question. Yes. 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 and 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? And 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? Thank you for your question, John. So to the first question, we are in fact more than ramping the 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 up 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 would say it 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. But it's all about building inventory. So 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. So that's for the manufacturing. In terms of the plants 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. And 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, John? Absolutely. Thanks so much. Thank you. Our next questions come from the line of Matt Phipps with William Blair. Please proceed with your questions. Thanks for taking the question. Congrats on this deal. Just curious, you guys will fund the Phase III here to completion and then also the ongoing Phase II multicore study. But 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. Now, 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. But it certainly has demonstrated and that's another reason we were interested in working with them, a keen interest of potentially developing tab cel beyond occurrence regulatory pivotal studies, both the Phase III allele study as well as the multi cohort. So there will be discussion and there have been discussion around the potential new type of work with TapCel. But again, at this stage, we want to focus and to be able to deliver on the expectations regarding the first indication, EBV positive PTLD and then of course the additional indication for label extension with our Phase 2 mystical study. Thank you. Our next questions come from the line of Salveen Richter with Goldman Sachs. Please proceed with your questions. Hey, 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. Thank you for your question, Blair. So 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, our first product, tabsell, on the very strong execution of commercial launch in the U. S. So, ATARA internally is really focused on the U. S. Launch, following filing and, of course, approval, hopefully. And we have built a team already. And Christian Yerema was here, has been able to build a team. We have a new GM, General Manager for the U. S, who joined us recently, Stephane Vertier, with significant experience in launching product in the U. S. So we're really investing and focusing on the U. S. Launch. Now the reason we decided to have a partner ex U. S. And right now in Europe and the number of emerging markets is really that we can avoid the cost and complexity of having to build a commercial infrastructure in that type of territory. So we have a partner that is already there, already successful, very keen and very motivated to launch successfully tap sell in this territory. So that's the current strategy in terms of commercial footprint for Atara. We also say that in the future, we will look at that product by product, asset by asset. But right now, right there, in terms of tab cel, we're 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. Yes. 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 commercial situation, is that when a patient is identified in Europe, we receive the HLA type of that patient or medical department, we find the right saline for that patient, then that particular product is being shipped to Europe for that patient to be treated in its institution. And that's a process that takes usually 3 to 4 days. And that's very effective there. Now 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. So 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 with QP release in Europe. So that will be transferred to Peer Fabry and they will be able to release the product in Europe there. So once the product has been shipped and released, that's a product that is basically controlled by PSLAD in terms of the sale of the product to the institution. And that's where they will be, of course, invoicing of the product to advance. Thank you. Our next question comes 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 what kind of data should we expect to get? Yes. I would refer back to what we say during the August call, Ben, which is that we are in regular discussion with the FDA. We have asked for Type B meeting, 1 on clinical, 1 on CMC front. And following this Type B meeting, we hope to be able to have a preliminary meeting and then filing in Q1 'twenty two. That's for the U. S. For Europe, we've cleared all the gates. And recently, we announced that we were granted accelerated assessment status for Type C in Europe. And we say that we plan and we confirm that guidance this morning, but we plan to file our MAA in Europe in November 2021. And then the last aspect is related to the ALLETE study data, where we said in August that we are planning to present this data at an appropriate congress in Q4 2021. So 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 TapCel. Okay. That's fantastic. And I think you kind of answered my next question, which was, have you guys had those Type B meetings yet? But it sounds like that hasn't happened yet. We're not commenting on that. Okay. We're just referring you back to the I got it. Okay. On this call, yes. Okay. Well, thank you very much. You're welcome. Thank you. Our next questions 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? And then also, what are your plans for developing tab cel in Latin America? Thank you. Thank you for your question. So in terms of the Middle East, we are not giving any particular guidance there. The reason Piafab 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've delivered ourselves, for example, some tab cel in Israel, compassionate use. So we know that there is a lot of needs in this region that could be covered. We don't have any particular detail with size of the market there. And we will hopefully be able to give more details once we get closer to the launch from that point of view. Now 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 they're on the way of and for good reasons, they're on the way to look at the regulatory filing and what's needed there. So we prefer to keep that for later. And 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, Miguel? Yes. Thank you, Pascal. Thank you. There are no further questions at this time. With that, that does conclude today's teleconference. We do appreciate your participation. You may disconnect your lines at this time.