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| Statement |
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| But the fundamentals of the business appear to be very strong from our perspective |
| So when you model it out, first of all the benefit to people at risk of getting HIV is incredible and the commercial opportunity for us and our shareholders is really exciting |
| And the clinical data is incredibly strong |
| The last two years, you've seen an acceleration -- a reacceleration in base business growth from Gilead, where we grew 7% and 8%, respectively for the year, driven both by our market-leading world-leading HIV business and virology business more broadly as well as our emerging oncology business, which includes cell therapy and Trodelvy an antibody drug conjugate for various forms of solid tumors |
| So, we're making progress and absolutely confident that both on the manufacturing side and the commercial side, we're well-prepared for early approval |
| So the market demand was very strong, both in the US and other markets |
| We're really excited about it |
| And we're really excited about it |
| So we're -- it's an exciting new chapter for Gilead from our perspective |
| So the business remains strong |
| We have an incredible commercial organization |
| As you know that the earlier data that's been shared is really exciting both in terms of the efficacy profile as well as the safety profile |
| So with every six-month subcutaneous injection you would expect to see a significant improvement in the real world over patients who are on the oral pills just not because the medicine is more effective |
| So, we're really excited |
| So, the interesting thing with manufacturing is we're getting better and more efficient at it every year |
| And to put it in context, we see it as a very large growth opportunity |
| And when you look at the incredible data from cell therapy we're comfortable and confident that you're going to see penetration of cell therapy |
| I mean, I think you have to frame it with the cell therapy business overall is really healthy and growing |
| And Trodelvy, our antibody drug conjugate that targets Trop-2 is a $1 billion product and also growing double digits |
| Remember, the cell therapies, we have data that shows an incredible overall survival benefit for patients both at later lines, but also in second-line DLBCL, if you look at the ZUMA-7 study, I mean this is like groundbreaking data in terms of the benefit for patients |
| We have the world's leading COVID antiviral for hospitalized patients where the sales are still very strong, but they fluctuate as you'd expect from time to time |
| I think appropriately it's probably a good thing for us and for patients |
| The -- and remember, again, as I said earlier, both Trodelvy and cell therapy have very long durability in our models in terms of the difficulty of biosimilars, the IP protection that we have around them these can drive value and growth for many, many years to come |
| To round out cell therapy, I want to talk about on either cell Arcellx, a great deal in my opinion the data at ASH looked really good |
| We think we have a really unique TROP2 product |
| It's a -- the Kite team has done an incredible job on kind of both the commercial model and the commercial logistics as well as manufacturing |
| We are clearly the world's leader in cell therapy |
| Both of the cell therapy franchise just like our HIV business are unique in that they have a very long product life cycle |
| That market has been developing over the last 10 years, as we'll talk about later we believe is poised for complete evolution over the next decade with the launch of an every six-month sub cutaneous product called lenacapavir by the end of next year |
| We still believe that we're going to get an attractive return for investors |
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| I mean it really is a huge problem |
| But cell therapy Q4 did experience some weakness |
| During Q4, you guys experienced some weakness in HIV |
| And then the other issue is that with the BCMA cell therapies coming on some of the hospitals don't have enough transplant beds that will resolve it |
| In the United States, there are some temporary headwinds that we've highlighted, that are very different than Europe |
| I don't -- I would -- we didn't experience weakness in HIV |
| The challenge is finding a partner agent for it |
| So when we take the sales in the quarter and you apply the net price across all of the sales, it resulted in a lower realized net price for the quarter |
| It also had other issues related to it from our perspective |
| That market is still in its infancy |
| What we saw was actually sales and it's a little -- HIV market is a little more complicated |
| There was one drug that was approved a handful of years ago that actually makes itch much worse |
| The challenge is that people are at risk of getting HIV don't tend to take the pills every day |
| 60% is still not too bad |
| This year we just made the announcement that our turnaround time in the United States and agreement with the FDA has been reduced from 16 days to 14 days |
| For prevention, it's much less than that |
| It's unpredictable when these large bulk orders will come in |
| This is not unusual in our HIV business |
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