Pfizer Inc. (PFE) Earnings Call Transcript & Summary

Ladies and gentlemen, thank you for standing by, and welcome to the Arvinas-Pfizer Collaboration Conference Call. [Operator Instructions] Please be advised that today's conference may be recorded. [Operator Instructions] I would now like to hand the conference over to your host today, Randy Teel, Vice President, Corporate Development at Arvinas. Please go ahead.

Thank you, operator. Good morning, everyone, and thank you for joining us to discuss our strategic collaboration with Pfizer, focused on our ER-targeting protectorate, ARV-471. Earlier today, we issued a press release announcing the collaboration. That press release as well as the presentation for today's call can be accessed in the Investors section of Arvinas website and also on the Pfizer website. With me today are Arvinas President and Chief Executive Officer, John Houston; Chief Financial Officer, Sean Cassidy; and Chief Medical Officer, Ron Peck. In addition, we're pleased to have our Pfizer colleagues: Andy Schmeltz, Global President and General Manager of Pfizer Oncology; and Chris Boshoff, Senior Vice President and Chief Development Officer Oncology, Pfizer Global Product Development, joining our call as well. Page 2 of our presentation is a reminder that today's discussion will contain forward-looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in the company's recent filings with the Securities and Exchange Commission, which we urge you to read. We undertake no obligation to update or revise any forward-looking statements to reflect new information or future events, except as required by law. Our actual results may differ materially from what is discussed on today's call. Pfizer's forward-looking statements are included as well on Page 3. With that, I'll now turn the call over to Arvinas' CEO, John Houston.

Thanks, Randy, and good morning, everyone, and thank you for joining us today. Together with Pfizer, we are thrilled to announce our global collaboration agreement to develop and commercialize ARV-471. This is a landmark event for both our Arvinas and for patients with breast cancer in need of potential new therapies. I'd now like to turn your attention to Page 4 of the presentation. At Arvinas, we have built our proprietary PROTAC discovery engine platform to design PROteolysis TArgeting Chimeras, or PROTAC, targeted protein degraders that are optimized to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. We are pleased to have built the most advanced and successful discovery and development platform in protein degradation and have achieved a scale that is unmatched in the space. Our vision has been to build on our strengths of drug discovery and development to create a global, fully integrated biopharmaceutical company that brings new medicines to patients with serious diseases. Our PROTAC discovery engine has allowed us to build a robust pipeline of protein degraders, targeting both well-validated and previously undruggable proteins. We are proud that Pfizer is joining us in our plan to bring ARV-471 to patients with breast cancer. I'll now refer you to Page 5 to provide an overview of ARV-471 before discussing the rationale for the collaboration, which I'll do jointly with Chris and Andy. ARV-471 is a PROTAC that induces degradation of the estrogen receptor, or ER, a well-known driver of breast cancer. ARV-471 currently is being investigated in an ongoing Phase II clinical trial for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. Despite advancements in oncology in recent years, breast cancer remains a considerable unmet need. Breast cancer is the second most prevalent cancer in women, and 1 in 8 women will be diagnosed with breast cancer at some point in their lifetime. Each year, over 200,000 women in the U.S. are treated for breast cancer, and 1% of new breast cancers are diagnosed in men. 80% of all breast cancers express the estrogen receptor. The current backbone of treatment for patients with ER+ breast cancer is endocrine therapy, which directly or indirectly targets ER. While existing endocrine therapies benefit patients, they have significant limitations. Despite these shortcomings, no new endocrine therapies have been approved since the ER-targeting therapy fulvestrant was approved nearly 20 years ago. Recently, the combination of targeted therapies with existing endocrine treatments have become commonplace in the management of advanced ER+ breast cancer. Of note, CDK4/6 inhibitors such as IBRANCE have been firmly established as a standard of care for the initial treatment of metastatic ER+ breast cancer. But even with these advances, breast cancer remains a major public health issue. Since the approval of fulvestrant, many companies have attempted to create a safe oral drug that degrade the estrogen receptor better than fulvestrant. We believe we have created ARV-471 to be exactly that therapy. Unlike fulvestrant, ARV-471 is delivered orally, and preclinical studies demonstrate that ARV-471 is a much more potent and effective degrader of ER than fulvestrant. We believe that 471 has the potential opportunity to become the future backbone of care in ER+ breast cancer from the adjuvant setting all the way through to late-line metastatic breast cancer. Now with that opportunity as a backdrop, we realize that ARV-471 may benefit from a collaborator that shares our commitment to combating breast cancer and whose global commercial capabilities would provide the perfect complement to our leadership in developing targeted protein degraders. Our rationale for the collaboration we're announcing today is on Page 6. We wanted a partner to accelerate and broaden both the development and commercialization of the ARV-471. We wanted a partner with a breadth of expertise, demonstrated success and a global footprint alongside whom we could build and integrated Arvinas. And it was important to us that we retain ARV-471 in our pipeline while sharing costs in this as we work with a strategic partner to bring its patients in need. In Pfizer, we have found a true strategic partner and have asked our colleagues from Pfizer Oncology to join our call today to talk about their experience in breast cancer and how we can work together to accelerate ARV-471 as a potential new therapy for patients with breast cancer. As we move to Slide 7, I'll turn the microphone over now to Chris Boshoff, Pfizer's Oncology Chief Development Officer. Chris?

Thank you, John. Pfizer Oncology is thrilled with this collaboration with Arvinas as we have been decided to see the early encouraging clinical data for ARV-471, a potential first-in-category therapy with potential to become an endocrine therapy of choice. We see a strong strategic fit for ARV-471 with Pfizer Oncology's portfolio and our overall vision to transform outcomes for people living with breast cancer. ARV-471 is a compelling example of external scientific innovation with the potential to deliver a breakthrough therapy to patients. From a clinical development perspective, Pfizer Oncology has a long track record and industry reputation for accelerating trials and innovative study designs without compromising quality or patient safety. We plan to quickly and collaboratively bring back to the table through our partnership with ARV-471. We plan to leverage our strong research and development expertise as well as global regulatory footprint, which has allowed us to study our medicines in patients with breast cancer since the early 1990s. With Arvinas, we plan to apply innovative approaches to global clinical trial execution, including digital solutions and virtual site engagement, allowing us safe time and drive efficiencies. We plan to also leverage our strategic partnerships with leading investigators. Patient efficacy and cooperative groups around the world supporting us to maintain an industry-leading breast cancer development program. There are significant synergies in our own portfolio that can help maximize the combination potential of ARV-471 with IBRANCE as the current market-leading CDK4/6 inhibitor. We will also explore additional novel combination partners, including with our next-generation CDK program. I'll now turn the call over to my colleague, Andy Schmeltz, the Global President for Pfizer Oncology. Andy?

Thanks, Chris and John. From a business perspective, Pfizer has long been a leader in delivering breast cancer innovation as evidenced by our in-line portfolio of 4 medicines as well as our exciting breast cancer pipeline. As John noted, there is still significant unmet need in hormone receptive positive metastatic breast cancer. Endocrine therapy, the current standard of care, has transformed the treatment paradigm, particularly over the past 5-plus years with the advent of combinations with CDK4/6 inhibitors like IBRANCE. Now we believe ARV-471 is poised to be the next scientific advance in hormone therapy. Our partnership with Arvinas puts Pfizer in a good position to leverage our leadership position, capabilities and infrastructure with our extensive breast cancer portfolio. We believe ARV-471 both as monotherapy and in combination with IBRANCE in the metastatic setting and potentially as monotherapy in early breast cancer could provide hope to many people. And in the future, potential additional combination regimens could be on the horizon, offering the possibility of even better outcomes. As Chris said, we're very impressed with the science here and excited for the potential of ARV-471 as the first PROTAC degrader in hormone therapy of choice. We're looking forward to combining our expertise with Arvinas to develop and commercialize 471 as a potential novel hormone therapy backbone for hormone receptor positive breast cancer. With that, I'll turn the call over to Sean Cassidy for a review of the details related to the transaction. Sean?

Thanks, Andy, and good morning, everyone. I'll begin on Page 8. As John touched on earlier in the call, this transaction is a worldwide co-development and co-commercialization partnership. This is a potentially multibillion-dollar agreement, under which Pfizer will pay Arvinas $650 million upfront and invest $350 million in Arvinas in the form of approximately 3.5 million newly issued shares of our Arvinas common stock priced at approximately $101 per share, which is a 30% premium to the 30-day VWAP on July 20, 2021. The collaboration agreement and equity agreement are separate transactions. Arvinas and Pfizer will share equally development expenses, commercialization costs and profits worldwide. Arvinas is also eligible to receive up to $400 million in approval milestones and up to $1 billion in commercial milestones. In total, this means that Arvinas is eligible for $2.4 billion in upfront equity investment and approval and commercial milestones. This is in addition to the worldwide profit share for ARV-471, which we believe is positioned to be a potentially best-in-class ER-targeting therapy. Looking at some of the other terms on Page 9, this collaboration offers an opportunity for Arvinas to build our development and commercialization capabilities worldwide alongside Pfizer, one of the world's pharmaceutical powerhouses. Arvinas will be the marketing authorization holder and will book sales in the United States, and Pfizer will be the marketing authorization holder and book sales outside of the United States. We will share leadership of and joint accountability for the clinical trial program with each of Pfizer and Arvinas leading multiple critical trials. From an overall financial perspective for Arvinas, the partnership decreases our planned expenses for ARV-471 and results in pro forma cash, cash equivalents and marketable securities of $1.6 billion as of June 30, 2021. This includes both the upfront payment, the equity investment as well as the existing cash that we had as of June 30. With that, we have the flexibility to invest in progressing our pipeline as rapidly as possible as well as continuing to invest in our industry-leading PROTAC discovery engine for our pipeline of the future, the platform that has produced 2 clinical programs that demonstrated efficacy signals in patients. Closing of the equity investment agreement is contingent upon completion of a review under antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States. The equity investment is expected to close by the end of August 2021. With that, I'll turn the call back over to John.

Thanks, Sean, and I'll pick up on Page 10. We've known that to maximize the potential impact to patients, ARV-471 would likely benefit from a partner like Pfizer with extensive experience and capabilities. Interim data from the ongoing Phase I dose escalation clinical trial of ARV-471 in patients with locally advanced or metastatic ER+/HER2- breast cancer showed this potential to be a best-in-class ER-targeted therapy. This study enrolled heavily pretreated patients with all patients having received prior treatment with CDK4/6 inhibitors. Despite this, the interim data from the Phase I study released in December 2020 demonstrated that ARV-471 has a deep ER degradation and a high clinical benefit rate while exhibiting an excellent safety and tolerability profile. We believe that these data position ARV-471 as a potentially best-in-class therapy in a large area of unmet needs. The development path to achieve success in the ER-targeting space is clearly defined but also compliant, requiring multiple pivotal trials in various settings of breast cancer. ARV-471 may show promise as both a monotherapy and in combination and even has the potential for use as an adjuvant therapy for patients with breast cancer. For a view of our upcoming milestones, I'll turn to Page 11. ARV-471 is currently in 3 ongoing clinical trials as a treatment for ER+/HER2- metastatic breast cancer, including a Phase I monotherapy dose escalation study, a Phase Ib combination study with IBRANCE and the VERITAC Phase II monotherapy dose expansion study. In partnership with Pfizer, we will jointly develop ARV-471 through a broad-based clinical program to design to position 471 as a best-in-class endocrine backbone therapy across the breast cancer treatment paradigm, from the adjuvant setting through to late-line metastatic disease. We intend to initiate at least 2 additional trials of ARV-471 this year, including a combination trial with everolimus and a study in early breast cancer. This sets up for a data reach 2022 when we expect to share data from the VERITAC monotherapy Phase II study as well as data from the Phase Ib trial in combination with IBRANCE. Also in 2022 with our partner, we intend to initiate Phase III studies across multiple lines of therapy in metastatic breast cancer, including combination with IBRANCE, followed by pivotal studies in the early breast cancer setting. We also plan to study ARV-471 in combination with other agents to identify other potential paths to patient benefit. We believe that this robust clinical development program is warranted due to the potential for 471 to be a best-in-class ER-targeting therapy. We look forward to advancing this promising therapy in conjunction with Pfizer. And as you can see on Page 12, we are delighted with our partnership with Pfizer for many reasons, not least of which is that it validates our confidence in ARV-471. It will also accelerate and broaden the development and potential commercialization of 471 and allow us to closely collaborate with Pfizer as we build our development and commercial capabilities. These capabilities will be critical for our entire pipeline, including ARV-110, which is currently in a Phase II trial in men with metastatic prostate cancer. Our entire disclosed pipeline is shown on Page 13 and is a result of over 8 years working on a PROTAC Discovery Engine. It includes both validated and previously undruggable targets in oncology, immuno-oncology and neuroscience. We've always known that partnerships and collaborations could play a role in expediting the delivery of these important new medicines. Today's announcement of our first strategic collaboration with Pfizer on ARV-471 is an important step on our journey. Now I'll close by saying that our commitment to advancing PROTAC degraders to patients has never been stronger, and we are grateful for the tireless dedication of our entire Arvinas team. It is their vision and tenacity that has allowed us to innovate and pioneer this new class of medicines. I'd also like to thank our partners at Pfizer for joining us on the call today and in their commitment to bring 471 to patients in need. We are looking forward to this new stage in the ARV-471 development, and we are excited to see the benefits that we can bring to patients together. Most importantly, I thank those patients who have volunteered to participate in our clinical trials. Without them, none of our progress would be possible. And with that, operator, we're ready to open the call for questions. Thank you.

[Operator Instructions] Our first question comes from the line of Terence Flynn with Goldman Sachs.

Congrats on the collaboration here. John, just wanted to confirm that Pfizer has had access to data from the ongoing 471 Phase I/II trials, including the IBRANCE combo trial. And then would love for perspective from the team on pursuing an accelerated approval pathway with the drug. I recognize you're going to start a broad Phase III program next year. But again, how are you guys thinking about a potential accelerated approval path on potentially a Phase II data?

The second half of that question, I'll certainly be able to pass on Ron Peck, our CMO. In terms of the process, yes, this has been a several months' process that we initiated at the beginning of the year. Pfizer and other companies were part of that process. And it is clear that the data that we had from our mid-December release was a significant amount of exciting data for people to pursue these types of partnerships. Pfizer have had access to other data since then as part of their diligence. And clearly, that's been a thorough diligence, and that's got them excited with the idea of this partnership. Ron, do you want to talk about Phase III and the potential accelerated plans?

Yes, certainly. Terence, I think when you're referring to accelerated approval, I assume that you're referring to a single-arm trial where response rate is the primary endpoint. And what I would say there is that, well, there isn't a [ crescimus ] in this disease, and it's also a setting where response rates are typically very low even with existing therapies like fulvestrant. Having said that, to think about moving this drug quickly through trials to reach approval, the situation in late-line patients is that the endpoints occur very quickly. These studies typically are designed around progression-free survival, and the follow-up is so short because the outcomes are so core. And as a result, the trials can be done quickly. And so while it's not a single-arm approach, it could be done through a Phase III. Having said all that, I would say that we are very actively with our new partners with Pfizer thinking about how can we advance this as quickly as possible. So we'll certainly be turning over all rocks in doing that.

Our next question comes from the line of Ellie Merle with UBS.

Congrats on the deal. Just in terms of moving into earlier-line settings, can you elaborate a bit on sort of what drives your confidence may be -- or maybe how you're thinking about the ability of 471 to show superiority versus, say, aromatase inhibitors and become a new endocrine backbone? I guess how are you thinking about how much we know about how much more degradation leads to greater efficacy and how to think about sort of the potential to displace sort of some of those earlier endocrine backbones?

Thanks, Ellie. Thanks for the question. And again, I might, in a second, hand over to Chris and Ron for answer to that. In terms of the competitive profile, as you know, from a mid-December data, we believe that both the degradation and the safety and tolerability profile we had really got us excited about the fact that 471 could have a potential best-in-class profile. That belief has continued, and we believe those elements of significant degradation, good tolerability and safety will drive that best-in-class profile forward. Ron and Chris, do you want to say anything about the second half of the question?

On the second question...

Yes. I'll -- sorry, Ron, do you want to start, Ron?

Yes. Yes. I mean maybe I can just kick it off and only just to say that the degradation is -- has been obviously validated with -- in the form of fulvestrant that has been viewed by most experts in the field as the most effective endocrine therapy today. But as John had pointed out early in the talk,that there are a number of limitations at -- one of which, of course, is how it's administered. The other one is that it is more of an indirect degrader versus the PROTAC technology that really hijacks the ubiquitin-proteasome system. The other thing that I would say, and then Chris can pick up from this, is that the experience of fulvestrant has actually proven that magnitude of degradation actually translates into better outcome when they've studied higher doses, the approved dose of 500 showing greater degradation than 250 and then 500 also translate into greater efficacy. That really is a good point of evidence that more degradation matters, and we've also shown that preclinically.

Thanks, Ron. I'll just add to that. As you know, there has been no [indiscernible] directly probably for the last 2 to 3 decades now. And I think an unmet need [indiscernible] that it's just over 2 years [indiscernible] in the [indiscernible] survival is approximately 10 to 12 months. And it's a significant unmet need [indiscernible] previous data that released [indiscernible] stable disease and [indiscernible] served in patients with previously heavily pretreated, including previous therapy with CDK inhibitors [indiscernible]. And that really provided additional confidence to us, and that [indiscernible] therapy has a significant potential in earlier months.

Our next question comes from the line of Alethia Young with Cantor.

Let me add my congrats on a very lucrative deal for both parties. My first one is just, obviously, I just want to talk a little bit about like how quickly and aggressively you can start potential adjuvant, neoadjuvant study and what that market potential you kind of think about could be, ultimately, since obviously, the upfront with $650 million, with a $350 million investment, it must mean multi-multibillion dollar investment -- multibillion dollar opportunities. And then just kind of following on to that, just in a space where there's, obviously, I think, assets best in class, but there's other assets roaming around, just talk a little bit about the potential for variable combination studies to truly, truly differentiate and kind of really push the strategy out kind of to make incredibly broad, large market opportunity here.

Thanks for the question, Alethia. And yes, certainly, the whole attraction of finding a strategic partner such as Pfizer was the possibility to both accelerate the development of 471 and to have a more comprehensive approach to our trials with the aim of getting a drug to patients in a more assertive way. So we're excited for the fact that that's a real strong possibility. We'll begin starting several new trials over the coming 1 or 2 years. So we believe this is going to be a very attractive way forward for 471. In terms of the commercial opportunity and how quickly to get adjuvant setting, I don't think we're describing any kind of detail today around when we get to the adjuvant setting. I don't know if Andy would want to say something about the commercial opportunity overall.

Sure. Happy to, John. Thanks. Look, the breast cancer category today is about $20 billion-plus overall and is anticipated to grow to $40 billion-plus over the next 5 to 7 years. Certainly, IBRANCE in 2020 generated $5.4 billion in revenue. And putting that in context, IBRANCE is exclusively in the metastatic setting. And we think that there is this opportunity for these combination regimens, a CDK inhibitor, IBRANCE, of course, is about 80% of the CDK category, in combination with 471 could really be the forward kind of standard of care regimen for first-line metastatic breast cancer. And then in the early breast cancer setting, I think all the studies with the CDK inhibitors are looking at 1 to 2 years of therapy and then stopping. Of course, today's standard of care with aromatase inhibitors in the early setting can be up to 5 years of therapy. So I think there is great potential given the safety and efficacy profile of 471. Obviously, a lot to be proven out with additional studies to have a -- to be a great advance, significant advance in the adjuvant setting. So we're super excited to move forward in partnership with Arvinas here.

Our next question comes from the line of Yigal Nochomovitz with Citigroup.

Let me add my congratulations to both companies as well. I just want to circle back on a previous question quickly. Could you just provide a bit more color as to how much the global alliance was catalyzed by Pfizer's interest in the data emerging from the Phase Ib combo with IBRANCE as opposed to only the Phase I monotherapy study?

Thanks, Yigal. Clearly, we ran a process, which was largely focused on our mid-December data release. And then after that, there was insulation of a company that would move to different stages of diligence, Pfizer being one. And at that point, there was access to some other data. I can't answer for Pfizer at what point the segment level picked up. We do know that there's been a number of companies, including Pfizer, that has been very interested in protein degraders for a number of years and have been tracking 471 for what length of time as well. I don't know if Chris or Andy want to say anything to this. But we're just excited of the fact that the data we saw certainly in mid-December was pretty exciting for them.

Thanks, John. Perhaps I can just add that you're correct, we did look at early data in combination with palbo, palbociclib and recognizing that these early data, it did provide us with additional confidence that these 2 medicines could potentially be combined into future pivotal trials. So it did help us make a decision. Thank you.

Okay. And just one housekeeping question. Does today's agreement contain any auction clauses that could expand the alliance to breast cancer degraders beyond 471 that may emerge from the earlier 2018 research collaboration and license agreement with Pfizer?

These are separate agreements. The discovery alliance, which is going well, is a separate deal and separate contract from this one.

Our next question comes from the line of Michael Schmidt with Guggenheim.

Congratulations to the deal as well, very impressive. Just perhaps another follow-up for the Pfizer team. I was just wondering, the decision to license a partner on this PROTAC product candidate, was it more driven -- was it exclusively driven by the Phase I data that has emerged so far? Or how much of the decision was driven by the mechanistic rationale as being a PROTAC perhaps in context of other oral SERD inhibitors that are being developed at the moment?

Chris, do you want to take that?

I will start and then hand it to Andy. This is, as I've stated, a truly first-in-category medicine. We are very interested in innovative medicines that could be potentially transformational and breakthrough medicines. And this clearly is the first-in-category medicine. The data we've seen, the clinical data also suggested to us that this could be a best-in-class ER degrader, and then go point, the preclinical data are very compelling. And the preclinical data definitely provided significant additional terms to us -- to execute this deal. Andy?

Just to add, clearly, over the past 5 years, the standard of care in the hormone receptor positive metastatic setting is endocrine therapy in combination with a CDK inhibitor. And we, of course, have lots of experience knowing that it's quite competitive even amongst the CDKs out there. And the next big advance is to elevate the hormone backbone. And both 471 is a PROTAC and we're aware of the competition out there with the other investigational oral SERDs, all have the potential to improve upon the current standard of care. We believe that based on our diligence that 471 is poised to be best in category and, of course, the combination of 471 with a CDK inhibitor like IBRANCE today and potentially downstream in combination with other investigational CDKs in Pfizer's portfolio can truly be transformational. So where we're -- have eyes wide open that there'll be many options out there. But we're excited for the regimens that are possible and the benefit to patients with breast cancer from this partnership.

Our next question comes from the line of Joon Lee with Truist Securities.

Congrats on the deal as well. So I have 2 questions. One is also on the palbo-471 combination. What do you have in terms of preclinical data that this is going to be either synergistic, additive or incremental? And also, does this preclude combination with other CDK inhibitors such as ribociclib or abemaciclib? Is there any reason why 471 wouldn't work just as well with those CDK inhibitors? And the second question is, I think many investors were expecting this would happen at some point in a collaboration deal but feel like it came a little bit earlier than expected, ahead of some of the key internal data as well as some data from the competition as well, specifically from Sanofi. So what, in particular, triggered this deal? Specifically, why now?

Yes. Thanks for the question -- for both those questions. In relation to our preclinical data that we had with palbo and 471, we had really significant synergy data showing that we are seeing profound tumor reductions in our animal models. So that data go is very excited about the potential of 471 in combination with palbo, and that's why we moved forward with that as part of our plan. So yes, there's a lot of preclinical validation for that synergistic effect. In terms of why now, we've got a lot coming up. We -- you name the fact there's a lot of competition. This is an competitive space in terms of SERDs. We believe we have the potential of a best-in-class profile. And we know that to close the gap and to close a gap in such a way that in the adjuvant or plus-line setting, we get closer and closer, we have to take on a much more comprehensive aggressive game plan. And there was a realization that we didn't want to wait to do that. We have sufficient exciting data for us to say, "Let's do it now." And we're spending that partner now. And we're just ecstatic that Pfizer is the partner that joined with us to move this forward. This is the right thing for us. This will allow us to move forward with a very strong plan to get 471 into the right pivotal trials next year. So this is the right time for us, absolutely.

Our next question comes from the line of Maneka Mirchandaney with Evercore.

Congrats on the partnership here. Just wanted to dive a bit deeper into the palbo combination strategy as well. Can you talk a little about what you're hoping to see over time from the 471-IBRANCE combo study to have confidence and superiority of that regimen versus CDK4/6 inhibitors in combo with aromatase inhibitors or fulvestrant? Wondering since, as you mentioned, fulvestrant has superiority versus AI as monotherapy, but that difference seems to get diluted a bit in context of CDK4/6 inhibitors. And then for the upcoming data at SABCS, can you give us a sense for the scope of data to expect there in terms of patient numbers and the [ doubles ]?

Yes. Great questions, and thanks for that. I will -- so I will be handing over to Ron to give a view. But for the palbo combo study we have right now is essentially a safety study. And as that progresses, we get more data, which we'll release next year, and that'll position us to decide the next steps in terms of pivotal studies with combinations. Ron, do you want to add to that and also talk about other combinations?

Yes. I think -- so I can say in terms of other combinations, because I know that was a question earlier, between Pfizer and ourselves as part of this partnership, we definitely have put a lot of thought into other combinations that will make sense and that we're -- just to start to investigate. And that includes also some of the Pfizer assets that make really good sense in breast cancer. I think the other question that I heard was with expectations around the abstract that was submitted for San Antonio. And essentially, as we had communicated in the past, we would be looking to present the data when we completed the dose escalation portion with regard to enrollment. And so you can expect that we'll have more data that includes the continuation of the dose escalation from the point that we presented back in December. And that would also include an update on the data on ER degradation from paired biopsies and safety as well.

Our next question comes from the line Matthew Luchini with BMO Capital.

Congrats on the deal. Two from me. So first, recognizing that it's a 50-50 split, could you just talk a little bit about the decision-making process around who will actually be doing what? What I mean is, will each -- will all decisions related to development plan, commercial strategy be made at a sort of like steering committee level? Or does one company or the other going to kind of drive certain aspects of the collaboration? And then secondarily, just I just want to confirm in terms of the actual deal-making process here. Were other companies that advance into later stages of diligence also able to see post December '20 update data? Or were -- or was it only Pfizer that had access to some of the early public data?

Yes. And I won't go into the details of how many companies go through this process, which is exciting that Pfizer went to the stage it did and we're a partner. In terms of the whole plan of working together is going to operate, it's clear that this is a 50-50 development both in the U.S. and ex-U.S. and 50-50 in terms of commercialization. We Arvinas will be building our capability to deliver on that 50 co-pilot status. We are going to make sure that we will be able to build the development capabilities to run the trials and build the commercial capabilities to do similarly. So in terms of governance, this will be a joint governance. It's clear that the teams already have worked very well together with looking at the potential things that could be done. The governance is going to be very clear both in terms of development, regulatory and commercial. So we're very happy with the process, and that will be 50-50 all the way.

Our last question comes from the line of Mark Breidenbach with Oppenheimer.

This is [ Jacqueline ] for Mark from Oppenheimer. Congratulations on the collaboration. I just had a few questions. Are you planning to present a PFS analysis along with response rate and disease control rate from the Phase I trial or 471 later this year?

For the advance [ Lab 5 ], it will be an end of Phase I release. So all the information we have at that time, we will be putting out there at that time.

Okay. Another question that I had was how much amount of clinical data versus upcoming oral SERDs will 471 will have to show to gain meaningful adoption?

Well, I mean, there's a lot of other SERDs in development. We believe that our profile, if it holds all the way through, means that 471 will have a meaningful opportunity in this market regardless of the timing. Obviously, with this partnership, we're going to be accelerating 471 as much as we can to close that gap. But the most important thing is the safety profile, tolerability profile of an oral-targeted degrader. I think that's going to be a significantly competitive profile. So yes, if data comes out from other companies, we'll be monitoring it, but we have great belief in the profile of our compound going forward.

Okay. And the last question would be, is the collaboration with Pfizer exclusive?

Sorry, I missed that last bit. Could you say it again?

Sorry. Is the collaboration with Pfizer exclusive?

Oh, yes. This is -- yes, absolutely. Yes, it's exclusive. This is Pfizer and us together and moving this compound forward as best we can all the way.

Thank you. There are no further questions. I will now turn the call back to John Houston for closing remarks.

Yes. I just want to thank everybody for joining us this morning. It's really great questions. And hopefully, you picked up on the excitement the team here, both Arvinas and Pfizer, have for this new collaboration. So thank you for your continued interest and support of Arvinas, and have a great day. Thank you.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.