Gilead Sciences IncGILD
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Gilead Sciences Inc Wells Fargo 21st Annual Healthcare Conference

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Mohit BansalAnalyst

Awesome. Thank you very much for joining us today. My name is Mohit Bansal. I am one of the biotech and pharma analysts here at Wells Fargo, and I am joined by Dr. Dietmar Berger, Gilead's Chief Medical Officer. Thank you very much, Dietmar, for joining us today for the first time.

Dietmar BergerChief Medical Officer

Thanks for having me. Yeah, of course.

Mohit BansalAnalyst

Awesome. Gilead has been a regular. This is fifth year in a row at Wells Fargo Conference, first time for Dietmar. We are excited to have some R&D discussions here.

Mohit BansalAnalyst

Yeah. Dietmar, let us just talk a little bit about the pipeline focus right now.

Mohit BansalAnalyst

It does seem like you have a mix of, obviously, building on HIV, where you have a leadership, and then oncology, some datasets coming in, immunology as well. Talk a little bit about when you look at the internal portfolio and some of the assets you acquired earlier this year, where is the focus internally is, and then what do you see the most exciting stuff out there?

Dietmar BergerChief Medical Officer

Yeah. No, thanks for that question. The current management team at Gilead, they joined 7 years ago.

Dietmar BergerChief Medical Officer

There was a clear realization that we want to diversify.

Dietmar BergerChief Medical Officer

That's been our strategy for some time, and we've clearly highlighted, yes, we have a clear stronghold in virology, and there's diversification in virology as well.

Dietmar BergerChief Medical Officer

That's important to us. Then there's really this expansion into oncology and into inflammation.

Dietmar BergerChief Medical Officer

From a portfolio perspective, we have made good progress in all three areas. On the virology side, there is this focus on both HIV treatment and prophylaxis, and we can really talk about how that is progressing. For example, we have just launched the combination of bictegravir and lenacapavir as a daily oral, for a very specific patient population. That is the Bixlenvo launch, where we have presented data on the islatravir-lenacapavir combination as a once-weekly oral. We are also working on longer duration treatment options, all the way up to once every six months treatment options. Then we have obviously the PrEP portfolio, HIV prevention portfolio, where, for example, we have submitted for the once-weekly lenacapavir, we have launched the once every six months, and we have clinical trials for the once every 12 months. Beyond that, we look more broadly at virology and antivirals as an opportunity.

Dietmar BergerChief Medical Officer

Then in oncology, we have to think about that in two ways. One is obviously, the cell therapy portfolio with Kite. That is also one of the acquisitions that you mentioned. That is the Arcellx acquisition that brings anito-cel fully into Gilead. That is where we have strong data in the fourth line plus multiple myeloma setting. We also have a study ongoing in the second to fourth line, and we are also preparing for studies in earlier lines, for example, in the first line setting. We are hoping for approval in this fourth line plus setting towards the end of the year. We think that is a really important opportunity because we feel anito-cel is a very differentiated option. Beyond that, with the Kite portfolio, with the CAR T-cell portfolio, we are also focusing on next generation CAR Ts, for example, bispecific CAR Ts, CD19, CD20.

Dietmar BergerChief Medical Officer

We are also looking at how can we expand that from oncology also into inflammation and neuroinflammation. We are also working on in vivo CAR T as an option, but that is a longer-term perspective, which is important. The current focus and standard of care, and that is where also the opportunity is really the ex vivo autologous. Then on the non-cellular therapy side, that is where we have another acquisition also. That is where we have the Tubulis acquisition that brings TUB-040 into our portfolio, which is ovarian cancer-focused, which had data with a 60% objective response rate at ASCO which really confirms the underlying concept of a new linker technology, also new payload technology, very stable linker, really confirmed with a strong efficacy and also good tolerability. Of course, early days, but we will explore that further, and we want to move that rapidly also into phase III studies in ovarian cancer.

Dietmar BergerChief Medical Officer

There is a whole portfolio behind that of ADCs from Tubulis. Besides that, obviously, we have TRODELVY.

Dietmar BergerChief Medical Officer

with really meaningful growth rates in breast cancer and also additional data coming, for example, in endometrial cancer, for example, in the adjuvant triple-negative breast cancer setting and also in small cell lung cancer and a whole slew of cooperative studies beyond that. In oncology, we are also trying to broaden the portfolio and really focus on tumor drivers, ADCs, some more targeted mechanisms with that portfolio, and we are making good progress there. On the inflam side, and I want to say inflam plus liver side, obviously you have Livdelzi as a marketed product, which is also making good headway from a commercial perspective. We have additional data with the IDEAL study, which takes us into an even earlier treatment paradigm.

Dietmar BergerChief Medical Officer

Also thinks more about normalization of ALT values, normalization of liver function, which we believe can give us a better long-term trajectory and which really increases the market size, roughly doubles the addressable patient population. Beyond that, we have on the inflammation side an array of what I consider really interesting molecules. We have an oral alpha-4 beta-7, where we are looking forward to present data later this year. We have an IRAK4 inhibitor, which we tested in cutaneous lupus, where we also will present the data later this year. We also have an IRAK4 degrader that is in early studies. We are focusing also on STAT6 degradation.

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