Okay, good morning. Thank you everyone for joining us on the morning session here on day two of the Jefferies Global London Healthcare Conference. I'm Mike Yee, one of the biotech analysts at Jefferies, and I'm really pleased to have with us up here on the stage, the Chief Financial Officer of Gilead Sciences, Andy Dickinson. Andy.
Thank you.
Great to have you with us. I would love to just maybe take a step back, talk about your outlook on 2024, but really sort of summarizing how, you know, Gilead has been positioned in 2023. Just reported earnings a couple weeks ago. A lot of people are obviously thinking about growth at Gilead, core business, pipeline, and how you're positioned for 2024. So maybe just coming away from third quarter, give us a snapshot about how you're feeling about things-
Sure.
We'll get into a little more of the details.
Yeah. No, thank you. First of all, thank you for having us. It's been a great conference. Appreciate it.
Yeah.
It's good to see everyone. Thank you for joining us. 2023 has been another great year for Gilead, and 2024 is set up for a lot of very important catalysts, as you know. So, maybe just to kind of step back, for those of you that haven't followed Gilead that closely, we are the world's largest virology company. We have a thriving and growing oncology business. When you look at our financials, if you look at our base business, which is the vast majority of our sales, excluding our market-leading COVID antiviral that's used in the, for hospitalized COVID patients, which I'll talk about, very important for us and for patients. But if you look at the base business, in the last two years, Gilead has returned to growth in a very meaningful and important way.
Last year, our base business grew 8% year-over-year. This year, if you look at our updated guidance, we're projecting 7%-8% growth, and that growth is being driven both by the core antiviral business, HIV. We have a much more stable hepatitis franchise, for those of you that follow the company, and the oncology business, which has two legs, our antibody-drug conjugate, Trodelvy, which is an incredibly exciting medicine, as well as our cell therapy business at Kite, are both driving significant growth. So, you know, we really have accelerated our growth as a result of the investments that we've made. So to your question, again, 2023, we have updated our guidance, another very solid year. We continue to execute.
The big difference between 2022 and 2023 going into 2024 is that, you know, the last three or four years with the new management team have been a period of investment. We've substantially increased the size and quality of our portfolio. The amount of money that we're investing in R&D is now on par with the rest of the industry. For years and years and years, we underinvested in R&D and had a much smaller pipeline than the industry. So we now have a very strong pipeline, a broad pipeline, one that we expect to drive significant growth in the future. We're growing at or above the median in the pharma industry, which is very exciting, and we think it's just the beginning. And now going forward, we have a whole host of clinical catalysts that are coming up.
So in 2024, I want to make sure everyone in the back can hear me, because I know it's loud there. So if you cannot hear me, please let me know. But in 2024, we have a number of clinical catalysts across the entire portfolio. For example, in the first half of next year, we have our phase III second-line non-small cell lung cancer data for Trodelvy. We also have our lenacapavir prevention data, phase III prevention data for HIV coming by the end of next year, at least one of the two pivotal trials. So... And that's just the tip of the iceberg. You'll hear more about this in the coming months in terms of where we're going. As far as, like, specific projections for 2024, obviously, we'll provide our updated guidance early next year, at the end of January or February.
We typically do that on our end-of-year conference call. What we can say, what we've said, and I'll reiterate, is that we're in a growth phase, and that we expect to grow at or above the median of the pharma industry, and we expect a significant acceleration of our top-line growth over the coming years as all of these clinical catalysts play out. So it's a really nice setup for what I describe as a new Gilead.
Okay, that was, that was a great snapshot. Now, you two parts: one is, coming out of third quarter earnings, there were some questions around the core HIV business that quarter. The first two quarters were quite strong. The third quarter, there was a comment about HIV pricing a little bit. I think there was maybe some confusion around that because you get-
Sure
A little bit the weeds of the different channel mix, and, some people were just wondering, can you comment about the core HIV business and pricing and how you're feeling out of third quarter? Explain that a bit.
Sure.
Then how you're thinking about that for 2024. I know you're going to give specific guidance, but you said acceleration. So you're saying you can grow faster in 2024 than 2023?
Well, certainly after we have the PrEP data, we expect a significant acceleration-
Got it. Okay.
B ecause the prevention market-
Got it
A s you know, is very large and largely untapped, and our every six months-
So, for those who are, the phase III capsid PrEP data, which would be a once every six-month injection?
Should substantially accelerate-
That, okay
R e-accelerate growth in HIV. That doesn't mean, though, that HIV is not a growth business in the base business. So if you just step back to your, to your question today, and if you go back to kind of our second quarter call, you're absolutely right, Michael, that the HIV business grew substantially in the first half of the year.
Mm-hmm.
Part of that, and again, you have to break the HIV market into the two different businesses. The HIV treatment business-
Mm-hmm.
W hich is the majority, significant majority of our sales, again, led by Biktarvy, which is the absolute gold standard treatment for HIV. Biktarvy is a $12 billion a year drug and growing. It's used in 62% of naive patients in the United States, a very high percentage of naive, naive patients outside of the United States and other major markets, and it's still growing. It grew two percentage points in the United States last year. So the HIV business is growing for treatment about 2%-3% a year in terms of volume demand growth in the major markets. In other markets, it's growing much faster than that. Prevention is growing much faster. In the third quarter, year over year, the prevention market globally grew 15%. Prior to that, it was growing high teens.
Last year, as you know, it was growing at 20%+. The prevention market is largely untapped. At most, in a very narrow definite definition of the prevention market, the prevention market is maybe a third of its way, kind of in the evolution in terms of the potential of the prevention market. So when you combine prevention and treatment, the HIV market is growing. It's going to continue to grow. Prevention is helping in terms of the growth of the treatment.
Yes, so let me be clear-
Yes.
Because this is probably one of the most important catalysts of next year-
Yeah
Is that the phase III capsid data for prevention is important because you're taking or giving the opportunity to prevent HIV with a single long-acting injection.
Exactly.
Okay.
Yeah.
Right, so-
No, it's transformative.
Okay.
I mean, and I want to make sure I finish the point, though.
Yeah
on 2024-
Yeah
because it's important, kind of the-
That was one of the drivers.
Yeah.
Go ahead.
That's one of the long-term drivers. But in the short run-
Yeah
Part of what's happening is, as the global economies have recovered from the pandemic.
Mm
As unemployment has come down, more patients have moved from lower-priced treatment reimbursement options in the United States, in particular, to commercial pay insurance.
Right.
So in addition to seeing the demand growth, you've seen an increase in the net price realized for our medicines, for us and other companies. We highlighted, starting six months ago, that the market was starting to normalize, and that that trend had kind of run its course, and that you're still going to see growth in the HIV business. And as I said earlier, you're going to see growth in our base business overall, including the oncology growth, but you won't have that tailwind. That doesn't mean that the HIV business is not growing. So just to finish the point on the third quarter, I think there was a bit of an overreaction in terms of the market interpreting some of our comments as the HIV business overall would grow at 2%-3%.
The point is, the demand growth in HIV treatment globally is 2%-3%. The prevention market is growing much faster. It's going to continue to grow substantially over time. And then, to your point, you start layering on top of it all of the new product launches that we expect to have in HIV. One of them is in prevention with this absolutely transformative every six months subcutaneous injection of lenacapavir, which is an HIV capsid inhibitor, first approved.
Mm-hmm.
It's already approved for treatment. This is not theory.
Mm.
This is a drug that's already approved for the hardest to treat HIV patients that have HIV, and now we're studying it in the phase III studies for prevention, which scientifically, we feel like is a lower bar in terms. The probability of success should be very high. Remember, we already have two drugs, our oral dailies, approved historically for prevention. We are the leaders in this space, and capsid should really unlock substantial growth in prevention.
Well, we-
Let me pause there.
Well, we're thinking, and we'll move away. The final thought around HIV is that we believe that the long-acting capsid data next year would benefit you first, certainly from a pricing and compliance standpoint.
Absolutely
B ecause the people who are on PrEP are not necessarily fully compliant. And then secondly, it could expand the market and grow utilization because, obviously, a very convenient once every six-month injection is great for patients.
Yeah, exactly.
Okay.
Look, I mean, the key in prevention-
That's a driver.
Yeah, I mean, again, to step back and kind of help people understand this, many people that take the existing approved therapies, including our two daily pills for prevention, take the drugs on demand. So if they fill a 90-day prescription-
Yeah
T hey may use 15 days, 20 days, some people use 60 days. But when you look at the market, again, just to put it in context, the prevention market when Truvada, which was the first double daily oral of ours that was approved for PrEP, went generic, the global market was about a $2 billion market for prevention, and the vast majority of the sales were in the United States. The market has continued to grow at a very high rate since that point in time.
Yeah.
Today, the branded market would be, I would guess, at least a $3 billion-plus market, and again, it's still only in the United States, predominantly in about a third of the market tapped.
Yeah.
So if you think about lenacapavir as an every six-month injectable that ensures compliance, which means you should get much better prevention and efficacy, it should open up not only a substantial market in the United States, but it will open up a much more substantial market, we expect, globally, including in Europe and Asia. So it should-
Are you suggesting that you should have reimbursement much more broadly than the current Descovy for PrEP, because I'm not sure that there's wide reimbursement beyond the United States. 'Cause-
That's exactly right today.
Uh.
But yes, the expectation is when. And again, if you look at the proof of concept, one of the other companies in this space has an approved long-acting therapy that is an injection, but a regimen that's less desirable for patients.
Right.
The important thing for investors is, if you look at their data, their data demonstrates exactly what you'd expect, that when you guarantee adherence with the long-acting.
Okay
I njectable, you get better clinical outcomes.
Ah.
That data should support pricing determinations in Europe-
So the European pharma company that has that approved-
Yes.
It's okay, GSK, I think they're in the other room. They have it approved. Is it reimbursed?
Again, I should know that.
Well-
I don't know-
They're working on reimbursement country by country.
They're working on reimbursement, certainly in the United States.
The point is, is that this is, looking at any Wall Street model, not, there's not much revenues in this, in models because there has not been reimbursement for daily pills for prevention. The fact that this is super compliant and guarantees efficacy is something that-
Should open the global market.
... payers outside. Okay.
Yeah, should open the global market outside of just the United States.
Okay. Last point on HIV, because it came up recently this week, and also people have been asking about it since the earnings call. Can you just comment about the recent, or any updates or what the timelines are for the various court cases going on in the U.S.? This is something that has class actions and others have impacted Sanofi and GSK as well. So for Gilead, is there any updates on the current HIV cases that are pending in the United States?
Sure. Again, maybe I just step back for those of you that are not familiar with this. This is a set of cases. There are. These are not consolidated. Well, they are consolidated, but they're not class action lawsuits. There's about. These cases are based on a very novel legal theory that you would really only see, unfortunately, in the United States. So this is a theory that we had a duty to innovate and to bring our TAF-based HIV regimens to market sooner than we did. This would suggest, for instance, that automobile manufacturers need to bring a safer car earlier than they can. It's outrageous, and it's something that, again, we see no merit in the cases. There are 25,000 plaintiffs in the California state courts. There's 4,000 plaintiffs in the federal courts. You know, we'll work through this methodically. The latest updates,
Yeah. What's the timing?
Yeah, I mean, maybe most importantly, if you kind of step back again, in the state court case, just to help people understand it, the plaintiffs have admitted that the product is not defective. These are life-saving products. They're still on the market. The risks that they're claiming were in the label from day one. So the plaintiffs have stated the product's not defective, and there was no failure to warn. They believe, however, that we should have brought out TAF earlier than we could have and than we actually did. So, when you look at where the state of the cases is, a significant portion of the cases have actually been dismissed over the last year.
Just to give you context, in the federal case, which is a smaller set of cases, 4,000-5,000 cases, I believe 27% of the cases have already been dismissed because it becomes clear that most of the plaintiffs cannot get an expert to support their claims, that they either even took the drug or that they were damaged in any way.
Okay.
In the state cases, 14% of the cases have been dismissed, and we're just kind of methodically working through it and managing this. We don't see—I mean, at the end of the day, again, these are completely without merit from our perspective. We're confident that we're gonna get the right outcome. We have an important... There's a California appeals court actually issued an order to the plaintiffs in the state court saying, "Tell us why we shouldn't throw out this case," given that this is a novel legal theory that could be very problematic.
Yeah
N ot only for the pharma industry but otherwise. They're gonna rule on. So then we had arguments and post-argument briefings. The California appeals court will rule on that in the coming months. The bar to throw out all 25,000 cases is very high. Whether we win there or we win subsequently at trial or at the California Supreme Court, we're confident that we'll win at the end.
So they had asked the plaintiffs to provide more information. The judge could either throw the case out, or it goes to trial, where you think you have a strong case?
Yeah.
Obviously.
You'll start to have a couple of key-
Okay
... bellwether trials, they call them. And again, there, there's a lot about this case that's subject to a protective order that we can't share. But what I can say is we have complete confidence in our legal position and our claims. The other thing, Michael, that's important to highlight is this is totally different than what many of the European companies went through-
Right. So that's what-
With some of the recent class action lawsuits
S anofi, GSK-
Right
S ome of those that had weighed on the stock because people don't like uncertainty about that. You have not taken any financial reserves on any-
No financial reserves.
Uh.
And again, this is a different set of claims. Again, this is not a defective product claim.
Right.
This is a duty to innovate claim.
Okay
... which is a novel legal theory.
Okay.
So-
All right
... it's really-
So you feel-
It happens more.
All right, you feel good about that. There is an update on that.
Right.
It may go to trial, but again, we've sort of summarized that. You feel good about HIV. We talked about capsid, long-acting, and you talked about some of the pricing-
Right
... issues.
Can I mention one other thing on HIV?
Yeah
... before we go to oncology?
Sure.
There are two other product launches that I would expect would come that people should be aware of and focusing on. One is a daily combination of our leading integrase inhibitor bictegravir together with lenacapavir. This is a two-drug combination. We had very promising phase I and phase II data that we're looking forward to sharing next year. We're moving into late-stage studies. So when you think about the, you know, next to Biktarvy, the other leading competitor-
Yeah
... in the HIV-
Yeah
... treatment space is a doublet of two. This would be very similar.
I saw this on the pipeline. So you would, we need more than capsid generally for treatment of HIV.
Correct.
For the treatment of HIV, your next step is to take lenacapavir as a once every six months. You would take a daily Biktarvy.
Yes.
But that's how you would have two antivirals on.
Yeah. It's a little bit different in that, yeah, the answer is yes.
Yeah.
capsid or lenacapavir-
Yeah
Is the new backbone we believe for all of our next generation HIV therapy.
Once every six months, very subcutaneous.
Well, but no, you don't have to... The beauty of capsid, our capsid, it can be formulated as a once-daily pill-
Uh-huh
A once weekly pill, every three months subcutaneous, or every six months subcutaneous.
All right.
What we're studying with bictegravir is a once daily co-formulated pill-
I see
- of lenacapavir
I see. Okay
A very small dose together with bictegravir. We also have promising data of a once weekly oral with another novel integrase inhibitor together with capsid that would also be a once weekly capsid-
islatravir?
No, that's separate from islatravir.
Okay.
This is our own integrase.
So a weekly-
Yeah.
You have a weekly integrase inhibitor-
Weekly integrase inhibitor.
To go with the-
Right
... with the weekly capsid pill.
Right. Right.
Right.
So to step back-
So you've got a weekly.
W e have nine molecules that are in development to partner with lenacapavir. Three of them are in phase II, three of them are in phase I, three of them are preclinical, five of them are integrase inhibitors.
Mm-hmm.
We have a wealth of compounds that you're going to see data on in the coming years, that are another big part of the HIV treatment story and the evolution of our HIV business.
For those writing down the catalyst, 2024, you will get some of this bictegravir, lenacapavir data.
We'll share it.
Daily pill?
Yes.
The opportunity to be a weekly pill.
Exactly.
Okay.
Yeah. In addition to the phase III PrEP data.
Yes.
So those, there's a world-
There are three drivers-
Right
... that are improving on and expanding, the prevention-
An already growing portfolio.
Okay.
Exactly. All right.
Uh-
So it's very powerful.
... very good. So now, with five minutes left-
Yes
... let's talk about, as important, there's $15 billion-
Sorry
... dollars in revenue there-
Yeah
... we're talking about. So, what is also important is, number one, Trodelvy.
Yes.
You guys acquired Immunomedics. Drug is approved, obviously, growing, launching in breast cancer. That said, another European pharma down the hallway has been reporting data both in second-line lung cancer, that was just at ESMO-
Yep
... and in HR-positive breast cancer.
Right.
Next year, they have first-line triple-negative.
Yep.
So they're working to come onto your home court.
Yes.
How does investors think about that Trop-2 versus yours? And why do you feel confident you're going to have steady growth of this when they have a competitive drug?
Yeah. Now, well, I think, first of all, we had a theory and a thesis when we acquired Immunomedics years ago, that not all Trop-2 antibody-drug conjugates are alike, and that the Immunomedics construct, which is Trodelvy, and is now approved in three separate solid tumor indications. It's $1 billion, roughly, of sales this year, growing rapidly, is very differentiated. And, for those of you that understand kind of antibody-drug conjugates, there are four parts of our construct that are completely different than the competitor's Trop-2 antibody. First of all, our antibody has much higher binding affinity to Trop-2 than the competitor antibody. Secondly, we have a completely different linker.
Our linker is hydrolyzable, which means that when the ADC gets into the tumor microenvironment, a portion of the antibody-drug conjugate is taken up and transported into the cell to kill the cell. A large portion, the linkers are cleaved, and the toxin is released in the tumor microenvironment. We think that could make a big difference, for instance, in squamous cell non-small cell lung cancer. We'll get to that.
Yeah.
Our antibody-drug conjugate ratio, the, I think they call it the ADR ratio, is much higher than the competitor. It's very similar to Enhertu, ours at 7.6 kind of toxic warheads per antibody. And then the final thing is that our toxin is very different. Our toxin is a derivative of irinotecan-
So-
... 1,000 times more
... so let me clarify.
Yeah.
So people see at ESMO, they had second-line lung cancer data. They hit on PFS, wait for mature OS. They believe that they're going to file on lung cancer. However, a lot of the benefit was driven on non-squamous.
Right.
It was asked on the call. I asked on the call that you believe that you will show a benefit both in non-squamous and squamous. You kind of just talked about some of those reasons. You think there's better affinity and greater uptake in those cells.
Yes
I think that's what you're saying.
Yes.
And so you feel very comfortable that you will have strong data. I mean, based on what you're saying, you think you're going to have better data?
Well, we think we have a, I mean, yeah, I mean, the answer is yes-
Okay
W e expect to have better data. But the-
That's a big catalyst, by the way. If you have-
No, it's-
If you had positive data that was better on PFS than they do-
Yeah. I think maybe-
I am pretty confident the street would be-
Yeah
... pretty excited about that.
Right.
Uh-
Just step back today. You have. If you look at our existing breast cancer data and our existing relatively small set of lung cancer data that we shared earlier this year, that's exciting. This data is in more advanced, more heavily pretreated patients. Again, it's not an apples to apples comparison. It's hard to do cross-trial comparisons. With all those caveats, if you look at our data, our view, of course, is that it's every bit as good, if not better, than the data that we just saw from the competitor in their studies. We have our second line, phase III, second line, non-small cell lung cancer trial, which is EVOKE-01, will be reading out in the first half of next year.
Yes. Yes.
We have a wealth of additional data coming from our phase II study in first-line non-small cell lung cancer.
Yes.
By the way, in our small data set in lung cancer, we're seeing a benefit in squamous cell patients. So again, the other thing I would highlight is these two competitors have very different side effect profiles.
Yes.
They are completely different, which underscores our point that the ADCs are not the same, and that-
I mean, if you show what data is this. We'll go back and look at this.
Yeah.
You're saying there's data that shows that you are very, good in squamous?
Well, that it's active in squamous-
It's active in squamous.
T hat's what we're saying. And the competitor data suggested that their construct is not active in squamous. So again, well, you know, the data is going to be important. We have a lot of data. Maybe what I would reiterate with the oncology portfolio, whether you look at Trodelvy or you look at our cell therapy portfolio with Kite, which is really exciting. We have a BCMA construct-
Mm-hmm
... that's partnered with Arcellx. There is a wealth of data coming over the next 12-18 months that is really going to give you a sense, definitively, of where we stand relative to the competitor, and whether our thesis in the acquisition really plays out.
60 seconds. Number one, how do you feel about the BCMA Arcellx CAR T at ASH, coming in a few weeks? You feel that is rock solid and absolutely competitive, and as good as the competitor?
Yeah, we are very excited about this BCMA program.
Okay.
We think it has the potential to be a best-in-class therapy, cell therapy for multiple myeloma. It looks, the early data looks outstanding, so-
The durability is going to be holding up, and it's going to look rock solid?
Again, I'll let you see the data. I love how you lead me to these answers. But the data that we've shared to date is very exciting, and we look forward to sharing more data. And I'll, you know-
Okay
L eave it to our partner to kind of take the lead there, but we're excited about this program.
Okay. We will see you at ASH.
All right.
Thank you very much, Andy.
Thank you.
I appreciate it.
Thanks for having us.
Thank you.