Good morning, everybody. I'm Chris Schott from J.P. Morgan. It's my pleasure to be introducing Gilead today. From the company, we have a presentation from Daniel O'Day, the company's Chairman and CEO. Following that presentation, we'll have a broader Q&A panel with the rest of the management team. Dan, Happy New Year. Thanks for joining us. Over to you.
Thank you, Chris. Good morning, everybody. Terrific to be with all of you today. It's really great to be back after, gosh, three years, right, since we were last here. I'm really pleased to be with the team up here today. We're gonna be focusing on our work for 2023 and beyond. I wanna start by thanking Chris and the organizers for the conference for getting us all together. Really, I wanna say right up front, today, after three years, we laid our strategy out, about three years ago. I can say we've successfully transformed the company, and we wanna talk to you a little bit about how we did that and what you can expect in the future.
As always, I wanna remind you that our presentation will include forward-looking statements, and I refer you to our SEC documents for a full discussion of the risks and uncertainties associated with these statements. In a nutshell, this is what we would like you to take away from today's presentation, the take-home message, so to speak. I mean, the first one is that we very much believe that the transformation is on track, that we achieved what we set out to do several years ago, and we have tangible evidence of that and impact of that. We're confident as a second point on this, in the growth trend for HIV, and I'll be speaking a little bit more about that.
We have very strong momentum in oncology, with a world-leading cell therapy business and an expansive medicine of other cancer modalities across more than 20 indications. I'll talk to you about how we're gonna accelerate this progress. Before we do that, let me start by recapping the journey that we've been on at Gilead Sciences together as a team. Our aim several years ago, as we laid out our strategy, was to create a diverse and sustainable business, paying heed to Gilead's legacy in virology, only strengthening that, and I'll talk about how I believe we've done that in HIV, COVID, and beyond. Building through both M&A and internal R&D, a world-class portfolio.
You can see that portfolio has increased double, but I would say, what's underneath that story is the quality of the portfolio that we have today and the potential of that portfolio. I'd also say that we're now a company with great colleagues on board, that can really consistently execute. I think you saw that every quarter in 2022 on both the commercial and the clinical side. I would say it's been a holistic evolution, I mean, really taking the best of Gilead, and I'll speak a bit about that, and adding to that. That includes both working on our culture and decision-making, which, I couldn't be more pleased with where we're at. When we laid out the strategy, and at the top of the slide, you see our 10-year ambitions.
As a strategy, you don't wanna change your ambitions every few years. These are for 10 years, and they remain consistent. They remain our true North Star as we think about prioritization and decision-making within the organization. The strategic priorities that you see on the other hand below here, and this is a subset of them, have adjusted because initially we had to build up the portfolio, and now as you can see, we're firmly focused on the following three things that will also form the basis of my presentation here today. That's maximizing near-term revenue growth, that's maximizing the impact of long-acting HIV therapies, and expanding and delivering on our oncology programs. Let me start with the first one, which is maximizing our near-term revenue growth. The first lever of near-term revenue growth is clearly our HIV business.
Biktarvy continues to be, you know, the treatment of choice in HIV treatment. It continues to grow. You can see the numbers up there. I think what belies our confidence overall in our oncology business that's been built up over the past several years is a few things. First of all, the pandemic impact affecting HIV is behind us now. Number two, and I'll talk about this, our first long-acting medicine is now approved in the United States and Europe. The final thing is we have no really no patent expiry throughout the course of this next decade. That was solidified with the TAF patent litigation that was recently completed. We see and expect an HIV revenue growth trend through 2030.
The second slide on maximizing near-term revenue growth is really the oncology business at Gilead. You'll see here it's now at a $2 billion annual run rate and growing rapidly. Our oncology impact is very tangible. We have a clear leadership in cell therapy, and it's still early days as we both introduce this technology and change standard of cares in large B-cell lymphoma and in other diseases, particularly as we move up in lines of therapy. Early days for that, but very promising results. I'll get back to cell therapy in the presentation. Trodelvy is also off to a very strong start and good success in its first indications in breast cancer, and we'll talk more about the potential for Trodelvy as the presentation continues.
Gilead has and will continue to play a critical role in public health. Certainly Veklury is a shining example of that. Now used in more than 12 million patients around the world, the vast majority actually in the developing world through our voluntary licensing. It continues to be the standard of care in the hospital setting, and was the first drug approved, as you know, for COVID-19 in the pandemic. We've reinvested and continue to work on that world-leading antiviral expertise for our novel oral COVID medicine that is now started one phase III trial outside the United States in high-risk patients. A new disclosure at this meeting here is that we will be starting our standard risk study that will start in the United States in the first quarter of this year.
More to come on that, but there is a significant medical need out there for patients in the non-hospitalized setting, and we believe that a novel oral COVID medicine that can help all patients could be a potential benefit for that, and we'll continue to pursue that. The second area of our strategic priority focus really deals with leadership in long-acting HIV care. It's hard to overemphasize the importance of Sunlenca as a medicine that could transform the HIV epidemic. We think it may be the strongest tool yet to help us end the epidemic. Just to put this into context, 'cause I think this is really the best of Gilead, really shining through.
This is a result of our own research and development, first, in kind medicine, 16 years of innovation, more than 4,000 compounds screened, and a truly unique molecule that was approved, both in Europe and the United States just before the holiday in the very late stage HIV patients. Our plans for Sunlenca go far beyond the late stage HIV patients, and you can see here we have trials ongoing in both earlier stage treatment and also prevention. I just wanna talk a bit about prevention because I think as we think about ending the HIV epidemic, where in the most sophisticated developed world, only about one out of four people that could benefit from taking PrEP medicine are actually on a PrEP regimen.
We believe that the advantage, if successful in our late-stage clinical trials of a twice-a-year subcutaneous injection, can transform the ability to protect people from ever getting the disease in the first place and really bend the arc of the HIV epidemic curve. This is true in both the developed world and very importantly to Gilead's focus on health equity in the developing world as well. I'm really proud to be part of a company that has such a unique molecule. In treatment, of course, we need a partner molecule, and you know the extensive nature of our R&D has been focused on finding that partner molecule. You can see here a representation of that. There are some new disclosures here today.
Since we've done our virology deep dive to this audience, some molecules have progressed, and those are identified with the blue star, and some new molecules have entered in, which are recognized with a red star. We'll continue to pursue these programs in treatment regimens that we believe people that are that need prevention and also patients that have HIV are looking for these types of long acting, so either weekly orals or less frequent subcutaneous injections. You can see this, and you can see on the right-hand side, we lead today in oral. With these programs, we intend to both lead today in oral, but also with long actings as we continue to pursue these programs. Now the third area of focus that I wanted to speak about today is our cancer medicine portfolio.
It's broad, it's diverse. You can see here it goes across almost every major tumor type, and we have a range of partnerships that have been thoughtfully curated to help us put a holistic approach to our oncology medicine approach. What I wanna do is just break this down a little bit, highlighting some of the key medicines. Just to point out that we have today 14 late-stage trials ongoing across our oncology portfolio and more than 5 medicines in those late stage alone and in combination. Let me start with the first one, which is Trodelvy. It's again, hard to overemphasize the potential here because of the expression of Trop-2 across so many tumor types.
We have an extensive development program, as you can see on this slide. Obviously, already supporting patients in breast cancer. When we dig into that a little bit deeper, starting with breast cancer, you know, 90% of Trodelvy's current business is in breast cancer, starting with triple negative breast cancer. We're the first and only approved ADC with overall survival benefits, and we've also shown now overall survival benefit in hormone receptor-positive HER2 negative, which is the largest form of breast cancer. You can see our strategy, which is to start with later stage patients with Trodelvy and then move up with a comprehensive development program into earlier lines of treatment to have an even greater impact on patients' lives.
This is a drill down on the current filing that we have in with the FDA, which is hormone receptor-positive HER2 negative. You can see the potential treatment pathway here. It's pending approval. The PDUFA date is about a month away, and it could be the only ADC in HR-positive, HER2 negative breast cancer that works in patients regardless of HER2 status. You can also see that with the very strong results that we saw in very late-stage recalcitrant patients, we have a lot of confidence in moving ups and lines of therapy to have that effect be even larger, and we expect first patient enrollment in the ASCENT-07 trial in 2023.
Trodelvy is also a key component of our lung cancer strategy, and you can see that represented here in both the first-line stage 4 lung cancer and the second-line stage 4 lung cancers where we have programs ongoing already. Of course, our approach in lung cancer goes beyond Trodelvy. It goes to the many medicines that you see here, both within Gilead and partnered molecules. We know in lung cancer, which is such an intractable large cancer type that has a huge need, that we need to also look at combinations.
We're doing those combination approaches within Gilead with a variety of different novel mechanisms, and also with partner companies that are leaders in the field in lung already. That you see represented here as well. It would be remiss not to point out the very exciting phase II data that was presented at an ASCO virtual event in December on TIGIT, which is a compound that we are in partnership with Arcus on. We're very encouraged by the separation of these curves. It's the largest body of evidence on TIGIT that has been communicated so far to date. It gives us great encouragement and validation as we continue to accrue patients into our phase III trials. The consistency that we've seen on safety and efficacy are very encouraging to us.
And yet another important potential medicine, in combination with other immunotherapy agents and potentially other medicines within our portfolio to move the standard of care, in lung cancer. Let me move now to another medicine that has true cross-tumor potential, and that's magrolimab. You can see here the number of cancer types that we are exploring this novel anti-CD47 mechanism in. We're in a leadership position with our hematologic malignancies as well, but I wanna give you an understanding of the breadth of these programs that could be used alone and in combination for magrolimab.
wanted to provide a brief update on our magrolimab ongoing phase III programs, the so-called ENHANCE trials across the disease states that you see here, and give you a bit of an update that we've had the IDMC exposed to the data, obviously, as they do from time to time throughout the course of the study. They've recommended that the study continue as designed and as planned. We will pursue an overall survival endpoint for this from a regulatory perspective, and we remain blinded to these results. A reminder that this is an event-driven study in ENHANCE MDS, and that the next interim analysis, we are expect to be able to give you an update on in some form in the second half of this year.
We continue to have confidence in magrolimab and wanna make sure we let the study run its course to get the true benefit that could come out of this trial for patients. We will be updating you more in the second half of this year. Continue on with our total clinical trial program with magrolimab. In cell therapy, I couldn't be more impressed by Kite and the team and their market leadership and patient reach. We have two therapies here and five different indications. Tremendous growth potential now as we see more and more community physicians referring patients into authorized treatment centers in both the 3rd-line setting and our early entry into the 2nd-line setting. We're expanding in lines of therapy, and we have studies in earlier lines as you see here, and also in more geographies.
We also have two transactions that are pending that we announced just before the holidays. One that is a partnership that provides a potential BCMA asset on our proven manufacturing and quality base for cell therapy with Arcellx. Another one to Munity that has novel advances in different types of solid tumors and also potential process improvements as we continue to invest in our leadership position in cell therapy, which we will continue to do. We're in a very good position as we look at our M&A strategy for the future. Because of the richness of our portfolio and the level of investment that we need to continue to do to realize the potential in the portfolio, we can be selective about M&A, given the M&A that we've done over the past several years, and we will be.
Of course, we'll continue to look at that in our business. Our capital allocation strategy will remain the same, which is first and foremost to invest in the promising pipeline for the benefit of patients and the medicines that are newly launched and established for our patient communities around the world. Secondly, look at M&A and partnerships that will complement with the strategy that I mentioned before. We'll continue to look to return money to shareholders with an attractive dividend growth policy. Then, our fourth but certainly not final, capital allocation priority is to repurchase shares to both offset dilution and to be opportunistic.
Again, we're disclosing here today that in total in 2022, we repurchased $1.4 billion of share, including almost $800 million in the Q4 , which is opportunistic share purchase, which belies the value we see and the growth of our business as we move forward. To summarize, and appreciate your intention and to turn it over to the team to have you hear from them as well. We just wanna say that, you know, we're very proud to be a part of Gilead Sciences, honoring the legacy, building on a diverse and sustainable portfolio. We're in a very different position today than we were a few years ago. What you can expect to see from us in the future, is even faster adoption of our portfolio and even greater impact for patients. I just wanna thank the colleagues. At Gilead that I get to work with every day who are tremendous inspirations for me. With that, I'm gonna invite Chris back up to get us into some Q&A with the team here. Thank you all.
Thanks very much. Excellent. Maybe to kick off the Q&A session here, I thought I might start just on the HIV business. I think last year you gave at this conference, I think some initial, kind of guidance about a stable to growing revenue base through 2030. Since then, we've had the TAF settlement, but at the same time, we had IRA move forward. Maybe as you sit here today, how are you feeling about that outlook for the existing business?
Sure. Thanks, Chris. It's Johanna. We feel very confident actually in our growth trend through 2030, and we believe it's gonna be a positive CAGR through 2030. The drivers of that have to do with our oral standard of care with Biktarvy in HIV treatment, as well, of course, as our long-actings, both in treatment and prevention that Dan mentioned a little bit earlier. Those are the two major pieces from a growth standpoint. I think the other thing that just opens it all up is the fact that there is no patent exclusivity issue in the next decade or so, and because of that TAF patent legislation brings us out to 2031, 2032, that also was a nice lift as well. Before the TAF patent, we were already suggesting that growth
Mm-hmm.
in the next decade or so. The IRA, obviously, the TAF and the IRA are gonna kind of compete a little bit from a positive and negative. We think the IRA, with what we know today, although it's still early days, we do believe that this is going to be manageable and that's part of the planning that we've put forth with a positive CAGR through 2030.
Great. Then the HIV category obviously is coming off a very strong 2022. Are we at a fully normalized market post-COVID at this point, or is there still growth, as that market just kind of recovers as we exit the pandemic?
Yeah. The last 5 quarters, we've seen consecutive growth in the market, so we're back at the 2%-3% range, which is pretty much normalized to your point. We would assume to see that going forward, that despite some of the different surges that we've seen with COVID, but we do think that's normalized. That's on the treatment front. On the prevention side, we've seen a really nice acceleration of that. The market's picked back up much faster in prevention than it has in treatment.
Hmm.
You're looking at about 19% to 20% growth there, and we believe with new long-acting agents like lenacapavir in the future in prevention, that will also continue to increase that growth because as Dan mentioned, only one in four that could benefit from a medicine in prevention, only today is using that. With new optionalities in this market, I think we're really gonna see an expanded growth in the back half of this decade.
Okay. Great. Then maybe just staying on the treatment side, on Biktarvy, you saw obviously very strong market share gains. How do we think about maybe 2023 and beyond? How much more room is there to go as we think about the share potential of that drug?
Sure. Biktarvy is at a 45% market share in the U.S.
Mm-hmm.
We have been growing on a year-on-year basis about 4%, so about 1% or a little less than 1% per quarter-over-quarter. We do believe that there's still an opportunity for growth with Biktarvy. We believe that because of its profile and what it offers for this patient population, we do believe that there is still room for growth in 2023 and beyond in the oral market. Obviously, as we expand, we'd also do believe that the long-acting treatments will also take on a different proportion as well.
On maybe the PrEP market for a second, we've had a competitor launch, I guess it's been in the market for about a year now or so. Just anything you've learned from that rollout as we think about lenacapavir and what that could do over time?
Yeah. I think the learnings there have a lot to do with the reimbursement and physician habits, right? Most physicians that prescribe in HIV are not used to anything injectables or Part B kind of area. That's been a big learning. Therefore, with Lenacapavir, we're being very clear and in the approach and the education that needs to happen...
Okay.
prior to, so that people understand how to use it and how to make sure patients have access to it. The access piece of it is probably the biggest learning.
Okay, great. maybe as I think in the slides you highlighted, kind of a range of treatment combinations you're looking at with lenacapavir. Can you just, at this point, you know, talk about what you're most excited about or most focused on as we think of those kind of, you know, seems like a growing list of combinations?
Sure, yeah. Hi, Merdad Parsey. We've done a great job, and I think Dan really alluded to the research group and the expertise that team has in terms of the medicinal chemistry and the discovery around developing new molecules, and that's where lenacapavir came from. That team's really redoubled their efforts to look for a different class of medication that will bring a similar profile. As you saw on the list, we have a number of options now, and our strategy has been to move as many forward as possible in parallel, with the goal of identifying the one with the best properties to allow us to get into an ideal position with a treatment regimen that could be long-acting, that could really match Sunlenca duration of activity.
Ideally, if we can find something that we can dose once every six months, for example, it would be the ideal combination. Again, in treatment. Important to remember that for prevention, we are in the PURPOSE trials, and those studies should read out. And for prevention, we're, I think we're set for with lenacapavir.
I guess on the treatment combinations, when do you think you'll be in a position to kind of identify those kind of lead assets? Is that something we can think about this year or next, or is it a longer-term process?
I think over the next couple of years. Some are in phase I, some are going to be in phase I, and really, because the mechanism of action is understood, because we understand sort of all the, all the, machinations, if you will, the key questions will be tolerability and, pharmacokinetic profile. We can figure that out usually fairly early on in the phase I studies. You know, we don't need to wait till the end of phase III to see really be able to pick something to be able to move forward. I think over the next couple of years, we'll have a lot better feel for which one really hits the mark for us.
Okay, great. Maybe pivoting over to oncology. I guess maybe first for Trodelvy in breast cancer. It was obviously a big year of news flow last year, both yourself and competitors. Can you maybe just help put us some context of how you see that product positioned as we kind of digest all the data we saw last year?
You wanna start?
Sure. we have, been approved in the marketplace with second-line metastatic triple-negative breast cancer, and I think that position is continues to stay strong despite new competitive data. I think that has a lot to do with the overall survival that we've shown in such a broad, you know, in this patient population. at, to this day, we are the preferred agent in second line with Trodelvy. I think the data you're referring to is also in a broader breast cancer patient population with HR-positive, HER2 low negative.
Mm-hmm.
In that population as well, we've shown in later lines of therapy, overall survival data as well. I think, you know, we're expecting PDUFA within the next month or so, and we're really excited because these are women that really don't have any other options so late in therapies. To show overall survival in this very late stage, I think is very exciting to not only for these women but also for the clinical trials that we have planned to move up lines of therapy as well. I think we're well positioned to really make a difference for patients.
When I think about competitive landscape within HER2, how do you think about that, how this is gonna practically play out in the market?
Yeah. I think in HER2 trial is, and you can speak to this better than I can, Meredith, but, in HER2 trial is earlier lines of therapy.
Mm-hmm.
I think you're comparing apples and oranges a little bit.
Sure.
Having said that, I also think it's important to understand the data and the patient populations that were studied. When you think about the IHC status and what that looks like, in triple-negative breast cancer, actually IHC 0 is actually a much higher proportion than it is in HR-positive. It's kind of the flip. There's still, however, in HR-positive, about 35% of the patients that are IHC 0, which Trodelvy is still today the only one that has proven efficacy and overall survival in this patient population. We do believe, depending on the patient profile-
Mm-hmm.
I think physicians will have to make a choice as to what better suits that patient with their profile and the different dynamics of the tumor.
Okay. Great. We're sticking on Trodelvy. As I think about Trodelvy in lung, could you just give some perspective there as I guess probably most, you know, relevant when we think about is kind of the competitive landscape there as well? Talk a bit about, you know, how the studies you've got wrong, you know, how you're thinking about that landscape playing out as well.
Sure. I think that actually speaks partly to your earlier question.
Sure.
Around other molecules in breast cancer. I think the thing to remember is Trodelvy is because we have a different target.
Mm-hmm.
we're gonna have a very different profile in terms of the tumor types that we're gonna treat and the lines of therapy. Lung cancer is a great example of that, where we believe that we'll be able to move into lung cancer, as you've seen with our phase III studies, and really bring a new option to patients with lung cancer, targeting Trop-2.
It's, as with anything these days, very competitive, and I think our approach really is to look at the broader portfolio, as you've seen, to look for opportunities to not only bring Trodelvy to lung cancer, but also our anti-TIGIT antibody and other approaches, so that we can look at combinations that could really move the needle, from what is already, you know, I think a lot of people would say, "Well, you know, IO's doing great for lung cancer," but I think it's really important to remember that, you know, the median survival and the number of people who respond is still pretty poor, and we have a lot of opportunity to do better for patients.
I think adding in a Trop-2 antibody, potentially adding a TIGIT on top of that and other options down the road will really give us that answer those questions for us. That is really a big part of our portfolio strategy, is looking at those intra-portfolio combinations.
Yeah. You mentioned TIGIT. I know we just came off, some data a few weeks ago. It seems like it is still an incredibly controversial category for the investment community, for better or for worse. Can you maybe just frame your takeaways from that data and what gives you confidence that, you know, kind of the signal we saw in phase II is gonna be able to show that kind of differentiation versus Keytruda as we think about the phase III?
Yeah. I think probably the first thing I would say is it's very important to remember what that study is designed to show, and that study is designed to show whether TIGIT adds efficacy on top of a PD-1 inhibitor. Dan showed the curves. I don't think it's ambiguous that TIGIT is adding to a PD-1 inhibitor at that point. We know that TIGIT alone doesn't really have a lot of activity and really needs a PD-1, to bring that additional activity. When you think about it in that context, the purpose of that trial, I think along with all the other data, that are there-
Yeah
... it seems pretty clear that TIGIT is gonna bring something. The question then becomes how broad does it become? How deep is it? How does it do when you look at apples to apples comparison? I think those are the studies that have to be done now. You're seeing us start to take on those trials where we'll be looking at those combinations in the front line setting, where we'll be looking at randomized data sets and really be able to establish that. I don't think there should be a lingering question as to whether TIGIT adds something to PD-1 inhibition. I think that now it's a matter of how much do we add? What is the overall survival benefit that we're gonna see over time?
Those are gonna require the phase III studies to read out.
Maybe on that same vein, can you just talk about your confidence that the PD-1 you're using is kind of able to show equivalent or, you know, kind of efficacy to a Keytruda?
We have a lot of experience with Zimberelimab. It's not limited to this one study. The performance of Zimberelimab in this trial is comparable and it is what we would expect. If you saw the ASCO plenary, you heard the discussants speak to that, and I think very eloquently speak to what we would expect given very different patient populations and study designs. And we have data in multiple tumor types and multiple trials that show that Zimberelimab is performing exactly how we would expect it to perform. I think doing cross-trial comparisons is always a risky business, and I would encourage people to not do that.
Okay. Fair enough. Moving on to the CAR T business, just elaborate a little bit on Yescarta and DLBCL and kind of the uptake and the opportunities that you see there?
Sure. We're very pleased with the growth that we've seen, especially the impact obviously on patients and the one-time treatment for a potentially curative effect. Our growth is actually coming from multiple areas and really is just starting. If you look at the, as Dan discussed, the number of products, the number of indications, those indications are expanding globally. We have expansion to new geographies, multiple indications, reimbursement coming on board, and especially as you look at second line, reimbursement coming on board in Europe now month after month, will continue that growth. Also, the number of ATCs are growing. We have over 320 globally now. We just announced the Daiichi Sankyo deal with this. Japan is the second largest market in the world. We're taking...
We now have the marketing authorization, and full rights back, starting this year. We'll start actually producing and manufacturing for Japan, early this year. Lots of expansion and growth opportunities just in DLBCL alone.
Can I ask about just the competitive environment? I know some of your peers have been challenged with capacity, to the extent those get addressed, whether we're getting to 2023 or, you know, however long that takes, how do you think about that playing out when there's, I guess, multiple companies that have full capacity available?
We keep saying the when, right?
Yeah.
It's not easy.
Keeps pushing out too.
It's a cell therapy.
Yeah.
It's very manual in nature. We have, you know, cell therapy researchers. We, you know, tend to call them cell therapy research labs, not manufacturing sites, ’cause these are really humans doing all of the work. We now have three facilities that are full-fledged commercially operational. We have the viral vector site in Oceanside, which is currently producing RVV for commercial supply and LVV for clinical supply. We're also producing and we'll produce that commercially as we expand into multiple myeloma. As you look at the manufacturing, I can't speak for other companies, but I think that is the ticket to entry. The one thing, though, I'd like to point out is it's not just about manufacturing. It's the supply chain.
It's the end-to-end teamwork that has to happen with a manufacturing supply chain and the commercial feet on the street that has to happen in that ATC to make sure that that patient from apheresis to manufacturing back to delivery, which we do industry best at 16 days, is really an intricate process. I think manufacturing is one thing to get up to scale, but now we have the know-how for multiple years now being able to expand our clinical development commercialization whole process end to end.
Great. Great. capital deployment. I know the company made a number of large acquisitions. I think the messaging seems to be that, you know, it's more tuck-ins now. Is that... Should we think about the strategy being kind of committed to when we think about BD going forward, it's gonna be more maybe what we saw in 2022 of these kind of smaller partnerships or smaller acquisitions?
Yeah. Thanks, Chris. Hi, everyone. I'm Andy Dickinson. I'm happy to take the question. The answer is yes. I mean, what you saw in 2022 is likely what you're gonna see in 2023. The reason is, Dan touched on this in the presentation, that we have a great portfolio today. It's strong, it's broad, we have a lot to digest and to work on, and we really like the growth profile. You've seen an incredibly strong growth profile in our base business. This year, we are very confident in the growth profile of the business going forward, both, you know, relative to where Gilead was, as well as relative to the broader biopharmaceutical sector. We don't need to do the same big deals that we did historically. That doesn't mean we're not gonna do things.
The deals that we did recently with Kite, Compugen, and Arcellx, the MiroBio deal, the Dragonfly deal, that gives you a good sense of the types of transactions that we're gonna focus on. We have a lot of flexibility. We generate a ton of cash flow, as you know. We're gonna be reinvesting that cash flow in the business, as Dan suggested. You should not expect us to do the large Kite Immunomedics type deals that we did to build out the core of our oncology franchise over the last five years.
As I then think about the cash the company's generating, if it is smaller tuck-in deals, I guess where does share repo fit into the mix? As you further de-lever, could we be thinking about that as a bigger component of the capital return every year?
I mean, yes, and it's still our fourth priority when you look at our.
Okay. Yeah.
... our, you know, how we think about capital structure and deploying our capital. You know, first and foremost, we wanna make sure that we have an incredibly strong internal portfolio, external portfolio, and that we're committed to maintaining and growing the dividend over time. We're gonna look at opportunistically at other things, including share repurchases. You saw that in the Q4 . As Dan said, we had some excess cash relative to where we, you know, thought we wanted to end the year. You should see more of that going forward. Not necessarily the share repurchase, just the optionality given-
Sure
... the cash flow that we're building and our cash position over time. We have a lot of optionality, both with respect to share repurchases, as also with respect to debt and whether we refinance debt or whether we just pay the debt off going forward.
Can I also just, when I think about OpEx and longer term margins, you've got now an HIV business that's growing. You've got an oncology portfolio that's growing nicely over time. I guess, how much can you leverage your existing infrastructure and have some of that top line growth kind of trend to margin expansion just drop to the bottom line? Do we need to think about still increases in R&D or SG&A to support some of the growth initiatives?
I mean, well, it's a great question, and one that I would break into two pieces. Well, first of all, we still have incredibly strong margins, as you know. I think if historically we underinvested in R&D in particular, we now have SG&A investment in R&D that is on par with the rest of the industry. You've seen a significant increase over the last three or four years. It was absolutely necessary to developing, you know, and building a company that is sustainable and will reach the growth targets that we have. We're kind of at the final stages of that, is the way I would describe it, especially in Merdad's development organization and Johanna's organization prior to a long launch. Assuming that we have positive data and launch, we'll build more on the SG&A side.
I think Kite's the same thing. You know, we still have a couple years of additional investment ahead of us, but there's a lot of leverage in the model. We are a very small company relative to our competitors. To your question, over the long run, absolutely, you should see a lot of that top line growth giving, you know, very significant growth in the bottom line over the next decade and beyond. We love the structure and kind of what the setup is from here, both for top line growth as well as EPS growth.
Great. Maybe just the last one, the last minute or so here. Just, looking around at everybody, just kind of as we think about 2023, any kind of pushes and pulls you'd highlight that we should kinda keep in mind as we think about the setup? I know you'll be giving guidance in a few weeks, but any color you can provide on that front?
You want me to take that?
Sure.
Look, no, I. Obviously, we'll be giving guidance shortly. I just wanna compliment the team. I think, you know, at the end of the day, we've got tremendous potential, I think, ahead of us. You know, you know, we're just at the beginning really of entering that the whole oncology space with the $2 billion run rates. You heard from Christi and you heard from Johanna about that potential. You know, we've got lots of readouts that are going to occur over the next couple of years.
Yep.
You know, some in different phases, some earlier phase, some later phase. I think what you can expect from Gilead is now consistent execution. You know, we were growing into oncology, I would say, last year and the year before, and I think we all feel like we have an organization that can continue to execute. We'll be giving you at the year-end results presentation, obviously guidance for the next year, but also the key milestones clinically that you can expect from us. That'll be coming in a few weeks' time.
Great. I think we're about out of time. Thank you so much for the comments today. Appreciate it.
Thank you.
Thank you.