Agios Pharmaceuticals, Inc. (AGIO) Earnings Call Transcript & Summary

Good afternoon, and welcome to the Agios Leadership Update Conference Call. [Operator Instructions] Please be advised that this call is being recorded at Agios' request. I would now like to turn the call over to Holly Manning, Senior Director of Investor Relations.

Good afternoon, everyone, and thank you for joining our investor webcast. With me on the call today are Jackie Fouse, Agios' current Chief Executive Officer; and Brian Goff, who will assume the role as CEO of Agios in August. We will hold a Q&A session with Jackie and Brian at the end of the call. Before we get started, I would like to remind everyone that some of the statements we make on this call will include forward-looking statements. Actual events and results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties and other factors, including those set forth in our most recent filings with the SEC and any other future filings that we may make with the SEC. With that, I will turn it over to Jackie.

Thanks, Holly, and thank you to all of you joining us today. This is an exciting and maybe a little bit emotional in a good way, moment from me, as I announced my transition to the role of Chair of Agios' Board of Directors and Brian Goff will assume the role of Chief Executive Officer effective August 8 of this year. I'm highly confident this is a great opportunity for our patients, our employees and our shareholders as we are able to bring Brian and his terrific set of experiences and talents into our overall team. From the divestiture of our oncology portfolio in 2021 to the evolution of our strategic focus as a genetically defined disease company and the shift in our approach to research, these strategic decisions have put Agios in a position of strength with great momentum and a very bright future ahead of us. It is because of this strength that I believe now is the right moment to evolve our leadership and deepen our skill set in ways that will enrich our impact and further drive our ability to develop life-changing treatments for people living with genetically defined diseases. The Board and I are constantly mindful of having good succession plans, and we gave careful consideration to what should come next for Agios to drive long-term impact for our people and patients. I strongly believe that Brian is the right leader to guide Agios through its next chapter. Brian has vast experience in hematology, rare diseases and commercial and operational leadership cultivated over the course of 30 years at global biopharmaceutical companies. He has a strong track record of leading rare disease product launches and accelerating their impact to patients as well as building and scaling companies' rare disease capabilities and leading high-performing diverse teams with strong cultures. Most recently, Brian was Executive Vice President, Chief Commercial and Global Operations Officer at Alexion where he was responsible for leading the global commercial and operations teams up to the time of the company's acquisition by AstraZeneca in July 2021. At Alexion, Brian led a successful launch of ULTOMIRIS, the successor to franchise leading rare disease therapy, SOLIRIS. He built a new neurology franchise and he developed the company's global rare disease-focused capabilities. He was responsible for a global P&L of more than $6 billion of revenues and a team of more than 1,500 people. Brian also previously held senior leadership role at Johnson & Johnson, Novartis, and Baxter [indiscernible]. As important as his business expertise, Brian's philosophy is aligned with Agios' mission and values. His personal dedication to making an impact for patients dovetails perfectly with Agios' purpose. Brian appreciates that at our foundation, we are a values-driven organization with a talented team dedicated to making a positive impact on the world through developing and delivering novel medicines. Brian is very enthusiastic about joining the Agios team and supporting the ongoing acceleration and maximization of the impact of the PYRUKYND launch, our clinical programs and our emerging pipeline. I'm excited about the energy that he will bring to Agios, and I look forward to working closely with him in my role as the Chair of the Board. Before I turn the call over to Brian, I want to say that it's been an honor and a privilege to be part of the incredible Agios team. Together, we have weathered many unprecedented circumstances over the past 3 or so years and supported each other through the highs and lows. During those moments, my colleagues remain steadfast with their team spirit and unwavering focus on patients. I have no doubt that this will continue to be the case for the future. While I may be stepping down from the day-to-day operations, I will continue to be a proud member of the Agios team. With that, Brian, I'll hand it over to you.

Well, good afternoon, everyone. And I'd like to start by thanking Jackie, the Board of Directors for their support and collaboration throughout this process. After my tenure at Alexion, I had the opportunity to thoughtfully and deeply reflect on what I wanted for the future of my career and what I value most both personally and professionally. As I considered my options, there were several aspects that were key to my decision-making. The first is the strength of a company's culture, and I firmly believe that this is a key ingredient for a high-performing business. The second is a purpose of steadfast dedication to patients that aligns with my personal values. And finally, an opportunity to drive growth and impact by applying my own strengths and experiences especially within rare and genetically defined diseases. It is the culmination of these factors that led me to Agios. Agios has a long-standing legacy of scientific excellence and clinical execution. It is on the cusp of broadening its ability to change the treatment landscape of genetically defined diseases with the recent launch of PYRUKYND and its extensive clinical and preclinical pipeline. The opportunity that lies ahead for Agios and the patients it serves is exciting, and I am incredibly proud to be joining this team. As we look ahead to this new chapter, I'll be spending the next several days, weeks and months getting to know all of the stakeholders who are important to the Agios story, diving into what makes this place great and evaluating the big and small ways we can drive long-term growth and value together. With that, we can open the call to Q&A.

[Operator Instructions] And our first question comes from the line of Marc Frahm from Cowen.

Maybe just to follow up a little bit on just kind of why is now the right time, Jackie, to make this transition versus maybe waiting a few quarters and having PYRUKYND show itself for the launch and then have somebody like Brian come in? And then maybe for Brian, just to recognize you're not even day 1 on the seat, but just anything strategically that you kind of view as a priority? Is it still a commitment of yours to get to cash flow positivity kind of with the existing portfolio and existing spend levels? Or do you think there are large changes either strategically from a pipeline perspective internally or externally -- more of a [ BD ] focus than the company has had that you'd plan on pursuing?

Great. So yes, thanks. I -- after we made our way through a number of pretty big decisions and strategic transitions, including the divestiture of our oncology business, I've been thinking for a while about the type of capabilities that we need at Agios that want to have to be successful, creating great therapies for patients and creating value for our shareholders over time as a rare and genetically defined disease focused company. And I think that is something that one has to consider at all levels of the organization. So we totally reconstituted our commercial team in that regard. And I like taking decisions proactively and from a position of strength. So as I work with the Board and was looking around it, how to plan for my own succession. I has a great fortune to meet Brian late last year and start to interact with him and get to know him. And he was considering his options. And I think the timing just align really well with respect to our thinking and my thinking about how we want to evolve Agios in the future. And with Brian being available after the closing of the transaction with AstraZeneca and Alexion and then him being very thoughtful and deliberate about what he wanted to do next that would align with his personal values and what he would like to do next in his career. And so these things are what they are when the stars align and things come together, where you see that this is a great fit. I think the chemistry between Brian and I was terrific from the first time that we interacted with each other. I'll let him make more comments about that. And because I'm transitioning to Chair of the Board, I think we've got great continuity with the situation. Of course, you'll hear how we're doing with the launch, which I think is going very well in our Q2 results call on August 4, and I think it's a great time for Brian to come in and be part of the ongoing terrific work that the team is doing on the PKD launch in the U.S. and start to jump in on the strategic thinking about the future label expansions with PYRUKYND and thalassemia and sickle cell and all the other exciting things that we have going on around here. So I think this is a situation where we're adding an amazing skill set and a great talent and Brian and strong cultural and style fit to our overall resource -- here at resource pool at Agios, our overall team. And I think it's pretty exciting. And I'm just happy that we have him. And he's available, enthusiastic and ready to go.

And Marc, I'll just add, first of all, thanks for the question. I'll build on what Jackie just said that the chemistry has been terrific since day 1. And this just feels right, and I'm excited to get started. To your question about strategic direction moving forward and priorities. I think from where I sit right now, priorities is probably the most appropriate area for me to comment on at this stage. And the first priority for me will obviously be to listen and learn a lot, both internally with our organization as well as externally with all the stakeholders, whether it's patients, providers, payers, certainly, investors. I really want to take in as much as I can to formulate some of the ideas ahead. The other priorities operationally will be the PYRUKYND launch in PKD and continuing that momentum. I think this is an incredibly important launch, obviously, for PKD patients. It's a commercial opportunity for Agios. But as much, it's also a platform for learning and capability building ahead for other therapeutic areas that we potentially move into. Secondly, with that in mind, we have clinical programs that are underway in exciting, high unmet need areas like thalassemia and sickle cell. I want to make sure that, that team is really well supported and able to deliver on the commitments that we've made, again, both for patients who count on us as well as our stakeholders externally. And then given the position of the balance sheet, that we have. And I think it's a really unusual characteristic in companies of our size, particularly in this environment. What I want to do is work with the team on very disciplined, thoughtful capital allocation decisions to ideally continue to build out and diversify our emerging pipeline. And the last thing I'll just say is, given the focus of the company in rare and genetically defined diseases, I will also look to help the organization as efficiently as we can, build those capabilities for both the short-term and the long term and value creation ahead.

Our next question comes from the line of Greg Harrison from Bank of America.

This is [ Mary Kate ] on for Greg. So I have a question for Brian. And we were wondering, should we anticipate a similar strategy as that employed by ULTOMIRIS with an expansion of core products, new indications with a focus on bringing forward improved versions? And maybe what would you do differently at Agios given its unique circumstances?

Yes. [ Mary Kate ], I didn't hear the second part of your question. So when we get to that, maybe I'll ask you to repeat that one. With the first one, first of all, looking to my experience at Alexion, I'm really proud of what I was a part of with ULTOMIRIS. And that is -- that rare disease knowledge and experience that I had, I would definitely look to leverage as much as I possibly can here at Agios. I think there are some areas that I would consider to be similarities across different therapeutic areas. And there are some that are very different. What is different in, say, unique about the situation at Agios is PYRUKYND is the first ever approved therapy for PKD patients. And so with that comes a very exciting opportunity, and there are launch challenges that come with that as well that I'll be working with the team to make sure that, again, we're learning, we're adapting as we learn more and we efficiently help patients find their pathway to PYRUKYND as quickly as possible. Now where we go from there, I think it's too early to say. But it is very exciting to know that as you know, we have assets beyond PYRUKYND in our pipeline that could create other equally compelling opportunities. And that was one of the key attractions for me joining this organization. So maybe I'll stop there and just ask, do you mind repeating the second part of your question?

Great. Definitely, absolutely. Maybe given your experience, where do you think you could see opportunity for BD and maybe new disease areas for Agios?

For business development. Well, first, as I mentioned, it is a position of strength uniquely, in my opinion, for a company the size of Agios to have such strength on the balance sheet. But that comes with a lot of responsibility and discipline that we will need to have. I will make sure that we open up the aperture to look at a wide range of potential assets for the organization and that could be therapeutically synergistic assets. I think it could also be a range of some early stage all the way out to -- on the cusp of revenue-generating assets. What will be most important is to make sure that, first and foremost, it's a strategic fit for the organization and then the discipline of do the financials make sense. And this is ultimately the asset better in our hands than anywhere else across the biopharma industry. But again, I think it's a really unique opportunity that Agios has moving forward.

Our next question comes from the line of Anupam Rama from JPMorgan.

Jackie, we'll miss you. Really cool stuff on focusing the pipeline and bolstering the cash position. And Brian, it's good to talk to you again, man. So I have a question you'll probably hear me ask this question like multiple times. But Brian, how do you view mitapivat? Is this an ultra-orphan asset where you kind of keep that ultra-orphan pricing for PKD and thalassemia? Or do you view maximizing the value of this program has to include sickle cell?

So Anupam, one, I'm really happy to hear you ask him that question because you've asked it to me about 5,000 times. So that's the first thing I want to say. Thank you for that. The second thing is you're not getting rid of me so easily. So don't forget that the chair can [ wield ] great power. So I'll still be after you, Anupam.

And I will add, Anupam, that, first of all, it's great to reconnect with you. I will secondly say that I'm not coming into this call that I listened into a few of the investor calls, and I've heard your question before. So thanks for asking it to me for the first time. And look, I think from where I sit right now, mitapivat is a special compound. And I do believe that the launch in PKD is very early, but I think it will be really important, both for Agios as well as for the PKD patients. Beyond that, in terms of the value that's created in other therapeutic areas, it's -- I'm going to say the classic piece that I'm sure you've heard before, which is let's wait and see the data. And then we can make thoughtful determinations about the best way to position mitapivat for other patient groups based on prevalence, the data that we see, the market conditions, the competitive environment and the like. And it's premature, but I will say I look forward to the day when we can have that thoughtful discussion.

Our next question comes from the line of Gregory Renza from [ America ].

Great. Jackie, Brian. Congratulations on the new roles. Maybe first, a question for you, Jackie. Perhaps you could just help us put your time at Agios, and I understand it's still underway, but just maybe put that in context with respect to your broader career just curious how navigating some of the challenges at Agios and capitalizing on those opportunities does factor in and bring context to what you've certainly experienced and insured throughout. And also investors are asking me in addition to sharing just what else do you see as next for you? And for Brian, you commented a bit just on the environment and certainly with respect to the sector's downward momentum of late. Perhaps you can just talk a little bit about how you have viewed things from afar and coming into Agios and where those opportunities may lie with respect to those assets that are out there privately, publicly, but also when it comes to [ willing ] buyers and sellers?

So as you know, I mean, when I joined Agios as CEO in February of 2019, I have been on the Board since late 2017 and have a bit of a unique relationship with the company just -- I knew the company from 2010 in the context of the partnership with Celgene and have gotten to know the company very well. So one of the consistent themes across the history of Agios that still holds today is our unparalleled expertise in cellular metabolism. And we've really stuck with that platform over time and that scientific expertise. And so that is a constant for us and something that I think will also carry into the future. And so along the way, as I came in to the CEO role in 2019, and we had the oncology business that had evolve to a different place than the rare genetically defined disease business with commercial drugs and all of the things that we had going on, it was tremendous to see that innovation brought to IDH-mutant patients. And with the evolution of the company, there was also the evolution of the cancer landscape and all sorts of things. But what I was struck by is I settled into my role and still amazed by the integrity of the science and the high quality of the science at Agios, and that remains the case with the team that we have today. And as we were making tremendous progress with the rare genetically defined disease parts of the business, it became clear to me along the way as everybody knows now because we made the decision to divest our oncology business, but we didn't divest the oncology business just to be able to put some cash on the balance sheet. Right now, we're very grateful to have that. But we made that decision also because we believe they're bringing focus to the rare and genetically defined disease programs that were emerging at the time was something that would allow us to move those programs even faster and accelerate their impact for patients with rare genetically defined diseases. And I think that focus has served us very well. We've made tremendous progress with our clinical portfolio in rare genetically defined diseases over the course of 2020 and into 2021, and we continue that in 2022. And so that same science has allowed us to create these innovations in the IDH space in the cancer space, but then also in PK activation and now focus on PK activation, where it's very clear from a business model standpoint, how we can see the path to take PYRUKYND from PKD into thalassemia and into sickle cell disease and impact hundreds of thousands of patients instead of thousands or tens of thousands of patients. So we can see that have impacting more patients and having an anchor drug that can be $1 billion-plus revenue opportunity and allow us to generate the resources to continue to invest in our clinical pipeline as well as our preclinical pipeline that Brian talked a little bit about earlier. So I think the -- some of the other things about the journey. I don't think the journey was -- it probably took some winding roads that were different than what we would have expected, but those winding roads opened up new and ever more exciting opportunities as we were willing as a team to make some pretty bold decisions and do those -- make those proactively. So before we had to, maybe and do them from -- take them from a position of strength so that we could avail ourselves of those opportunities and put ourselves in a great position for the future. And so I think that's where we are today. And again, having the opportunity to make a very proactive and deliberate decision to bring somebody like Brian into the team with his extremely valuable skill set and personality and style at the moment where we are fully moving into our future as a rare genetically defined disease-focused company is just a tremendous privilege to be able to have that situation present itself. And for me to stay part of the team as Chair of the Board and worked as a partner with Brian. So I think he's going to help us be even more successful in the future than we have been up to now, we've been very successful up to now setting this thing out to do great things for patients. So that's how I feel.

Yes. And I guess for the question that you posed to me, Greg. As I look at Agios within the broader environment, as I was looking around for my next career opportunity, what was important to me was, as I mentioned, does the purpose and the values of the company doesn't line up with the way I think about my own personal purpose, number one. Number two, the key ingredients of the company, I really believe are in place, whether it's the culture, the talent, the launch that is underway with PYRUKYND, which is a first approved launch for this therapeutic area. That's a really great opportunity. Clinical development is underway. And again, the BD optionality that we have. Those were really important. And I think, frankly, all of that is underappreciated, the more that I've learned about Agios. And so I assessed, do I think I can make an impact in this organization? And my answer, I hope at this stage is an obvious clear yes. That's why I'm thrilled to jump on board and return to the rare and genetically defined disease arena with Agios.

Our next question -- one moment for our next question. Our next question comes from the line of Mark Breidenbach from Oppenheimer.

Apologies if this came up earlier. I joined a little bit late, but I was wondering if Brian could comment on -- given his experience at Alexion, if there are any elements of the commercial strategy for SOLIRIS and ULTOMIRIS that could be directly ported to PYRUKYND launch in terms of finding -- hunting down relatively hard to locate patients for a disease like pyruvate kinase deficiency?

Sure. Mark, this is Brian. And what I would say -- and I'm going to use different words than hunting down and finding and so forth because there's a lot of elegance that's needed in the rare disease, genetically defined area. First and foremost, in my experience of 10 years in this arena, every patient journey is unique and different. And having an organization in every functional area, appreciate that and learn how to adapt and rally around each of those respective journeys to deliver the products that the patients count on and the experience in the best way possible is the most important thing. I do expect that, as I learn more about the launch that is underway already with PKD with PYRUKYND, that I will find plenty of similarities from my past life, particularly where I would draw an analogy is when SOLIRIS first launched for GMG, for generalized myasthenia gravis in urology, that was the first FDA-approved therapy in more than 60 years. And there is a parallel to PYRUKYND as the first ever approved therapy for PKD. So with that, that creates an opportunity to be a pioneer and to really help patients elevate for themselves a new standard and a new goal for their quality of life. But it also is a heavy lift educationally for clinicians who have not really had therapeutic choices before. And I experienced that with SOLIRIS and GMG, and I'm sure it will be similar dynamics with PYRUKYND in PKD. And the other thing, and I'm sure we'll talk about this a lot more is that it requires a bit of patience to allow us to learn, to adapt, to build some of these new capabilities, to become more efficient at helping patients get to a diagnosis, get to therapy. And in the case of PYRUKYND, what will be important over time is staying on therapy. And I'll look to amortize as many of those learnings as possible.

And our next question comes from the line of Andrew Berens from [ SVB Leerink ].

A couple of strategic questions for Brian. The company previously have mentioned pursuing external BD opportunities and wondering if that's still going to be a focus? Sorry if you answered that already, but I did join a bit late. And then how should we think about the R&D spend going forward? Jackie and team has obviously streamlined the company and trimmed a lot of the expenses, but it does still feel like this room and do more and become more efficient.

Yes. Nice to speak with you, Andrew. On the first question for external BD, my response would be, yes, we will look at external opportunities, given the strength of the balance sheet. That said, we will have an extreme level of discipline to make sure that capital deployment is very efficient, very strategically aligned with where Agios should go as an organization and where there's a great strategic fit. I think it would be hard for us to be successful for the long-erm in any biopharma organization if you don't look at pipeline innovation, both internally and externally. So that will be a key ingredient going forward. And then for R&D spend, I really respect the bold decisions that were made recently by Jackie and the team to essentially refocus the research part of the organization towards those assets that have an established pathway towards value creation even though they're early, and that still will carry forward. And for R&D, more broadly, we have some important investments to make -- to carry forward the clinical development programs, especially in areas like thalassemia in sickle cell disease. But I need to learn more, frankly, once I get started about where there could be other efficiencies and how best to allocate that spend.

This does conclude the question-and-answer session of today's program. I'd like to hand the [ program ] back to Jackie Fouse for any further remarks.

Thank you. Thanks, everybody, for joining us today. I'm really excited that we're bringing Brian into the team. He -- his enthusiasm for the future of Agios is contagious when you're around him for a little while. So I'm sure we'll look forward to meeting and interacting with all of you, and I look forward to continuing to being part of the team as Chair of the Board and pursuing some of my environmental projects as some of you know a bit about and then we'll be happy to talk about those over time as well. So good luck, everybody, good luck, Brian. We're happy to get rolled on this, and thanks again for joining us for the call this afternoon.

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.