Sunday, July 28, 2024 6:46:36 PM
Some of the positive comments, especially about Ocrevus ('We expect that Ocrevus subcut represents an incremental CHF2 billion in sales opportunity and we expect this to be increasingly visible in the coming quarters as we are already starting to see some strong pickup in our very early launch countries in the EU.'), may be behind the strong price action lately. From the Roche earnings call:
"Our key brands Vabysmo, Phesgo, Ocrevus, Polivy, Evrysdi, Hemlibra, they delivered an additional almost CHF2 billion in the first half of the year.
....
Phesgo continues to grow very impressively....I want to touch quickly on Tecentriq here, if you sort of scoot down to the bottom part of the chart. So you can see here that the decline in Tecentriq is actually being more than made up for by the growth in international and in Europe. Going forward, we expect Tecentriq to grow in a low-single digit range as we see sort of more increased competition as we begin to reach peak in some of our key indications like HCC and small cell. While we're on the topic of Tecentriq, I'll also mention our subcu formulation, we are seeing good uptake following the EU approval, especially in the UK, where the conversion rate has already reached 32% and we are expecting EU approval -- I'm sorry U.S. approval later this year.
...and Phesgo growing year-to-date by 60%, that strong growth momentum for Phesgo just continues. The global conversion rate currently stands at 41%. You may be looking at that and saying well that looks the same as we saw in Q1 and that is correct. In Q2, we added another five launch countries to the calculation of the global conversion rate, so that's why the rate remains stable. However, if you actually look at the rates in earlier launch countries, we do continue to see that conversion increase. A great example is the U.S., where we are up from 24% percent in Q1 to 26% in Q2. We also continue to see an overall further penetration in HER2 positive breast cancer in general. So if you take Phesgo and Perjeta together, and this bodes well for a scenario in which you see more than 50% of Perjeta sales being converted to Phesgo by 2026.
....
I will just quickly touch here on Lunsumio and the fact that we are excited about the positive phase, the positive data for subcutaneous formulation and third-line follicular lymphoma. The subcu formulation has all the benefits of the already available IV formulation, including no need for hospitalization, fixed treatment duration, but on top of the convenience of administration, it also seems to require less steroid use.
We plan to file Lunsumio subcut in the second half of 2024 with global regulators. (I haven't really looked into this but I am assuming Halo is not involved and I wonder if any other company is.)
Moving on to neurology. Our neurology franchise achieved CHF4.6 billion in sales for the first half, representing an impressive 13% growth. Ocrevus' strong growth momentum continues at 8%, driven by all regions. Not only is Ocrevus the market leader in the U.S. and the EU, but it has also reached a milestone of 1 million patient years of cumulative exposure. Furthermore, our six-month subcutaneous formulation has received EU approval and U.S.
PDUFA is set for the 12th of September. Again, this is 2 times per year, 10 minutes to treat your MS. We expect that Ocrevus subcut represents an incremental CHF2 billion in sales opportunity and we expect this to be increasingly visible in the coming quarters as we are already starting to see some strong pickup in our very early launch countries in the EU.
.....
And again, we are very much focused on the conversion into Phesgo, which provides a lot of stickiness and that we would fully expect Phesgo conversion to be above 50% in many markets.
Bruno Eschli
Okay. Then we move on. The next one would be Simon Baker of Redburn. Simon?
Simon Baker
Thanks very much, Bruno, for taking my questions. Two if I may please. Firstly, Teresa, you mentioned on Tecentriq subcutaneous, the strong reception that's received in the UK. The other strongly received subcutaneous formulation in the UK recently has been Ocrevus, according to the media, there have been suggestions that there is very considerable demand for Ocrevus subcut. So I was just wondering if you could give us an idea of how generalizable that UK experience is? I know the UK has a particular passion for subcut formulations. And what does this mean for Ocrevus subcutaneous beyond the UK, across the world? And do you see maybe the US, ex-US sales split, balancing up between now that we get to a subcut formulation?...
Teresa Graham
Absolutely. And when we look -- so it's a great question on Tecentriq subcut. So I think that in terms of the UK experience, we saw great uptake with Phesgo. We've seen strong uptake with Tecentriq subcut. I think that is quite generalizable for the UK market. I think anything that removes patients from having to go into the system and allows them to go home or to get a faster infusion or a faster injection, that actually frees up chair time and frees up office time, those are going to be very attractive to the UK system, and frankly, attractive to any system that's under financial pressure, which is most global healthcare systems around the world. So I think this is why we are again, really doubling down on devices going forward.
In terms of the Ocrevus subcut, I do believe that bringing the subcut formulation to Europe and to the rest of the world will provide additional opportunities for Ocrevus to reach patients. The initial out-of-the-gate orders for Ocrevus in those countries that have the ability to move quite quickly after approval are already quite strong. Again, you'll start to see the sales for Ocrevus play out of in the coming quarters. But I think this could be something that does equalize that US, EU, rest of world balance as we start getting reimbursement for Ocrevus subcut around the world.
Again, we think that in and of itself, it's a USD2 billion opportunity. And so that's USD2 billion on top of what we've already gotten from the IV space. So this isn't just going to be about cannibalizing our IV business. This is going to be about both in the US and outside the US, expanding to new patient pools. It's very attractive on the Ocrevus side. Just to control expectations a little bit, on the Tecentriq side, I know I mentioned it in my presentation, but we think with Tecentriq, it's largely going to be a conversion strategy. And so that's probably about an incremental USD200 million upside for Tecentriq, while the opportunity for Ocrevus, we believe, is much, much larger.
Simon Baker
Yeah. That was really, really helpful. Just one very quick follow-on going back to Ocrevus subcutaneous. And if you just remind us what the IP situation is? It looks like it's patent-protected to September 2030, but any additional comment on that would be really helpful?
Teresa Graham
Yeah. So I think clearly Ocrevus is sort of end of the decade, but we shouldn't make any broad, sweeping statements about where we think that might go with new formulations and new doses."
"Our key brands Vabysmo, Phesgo, Ocrevus, Polivy, Evrysdi, Hemlibra, they delivered an additional almost CHF2 billion in the first half of the year.
....
Phesgo continues to grow very impressively....I want to touch quickly on Tecentriq here, if you sort of scoot down to the bottom part of the chart. So you can see here that the decline in Tecentriq is actually being more than made up for by the growth in international and in Europe. Going forward, we expect Tecentriq to grow in a low-single digit range as we see sort of more increased competition as we begin to reach peak in some of our key indications like HCC and small cell. While we're on the topic of Tecentriq, I'll also mention our subcu formulation, we are seeing good uptake following the EU approval, especially in the UK, where the conversion rate has already reached 32% and we are expecting EU approval -- I'm sorry U.S. approval later this year.
...and Phesgo growing year-to-date by 60%, that strong growth momentum for Phesgo just continues. The global conversion rate currently stands at 41%. You may be looking at that and saying well that looks the same as we saw in Q1 and that is correct. In Q2, we added another five launch countries to the calculation of the global conversion rate, so that's why the rate remains stable. However, if you actually look at the rates in earlier launch countries, we do continue to see that conversion increase. A great example is the U.S., where we are up from 24% percent in Q1 to 26% in Q2. We also continue to see an overall further penetration in HER2 positive breast cancer in general. So if you take Phesgo and Perjeta together, and this bodes well for a scenario in which you see more than 50% of Perjeta sales being converted to Phesgo by 2026.
....
I will just quickly touch here on Lunsumio and the fact that we are excited about the positive phase, the positive data for subcutaneous formulation and third-line follicular lymphoma. The subcu formulation has all the benefits of the already available IV formulation, including no need for hospitalization, fixed treatment duration, but on top of the convenience of administration, it also seems to require less steroid use.
We plan to file Lunsumio subcut in the second half of 2024 with global regulators. (I haven't really looked into this but I am assuming Halo is not involved and I wonder if any other company is.)
Moving on to neurology. Our neurology franchise achieved CHF4.6 billion in sales for the first half, representing an impressive 13% growth. Ocrevus' strong growth momentum continues at 8%, driven by all regions. Not only is Ocrevus the market leader in the U.S. and the EU, but it has also reached a milestone of 1 million patient years of cumulative exposure. Furthermore, our six-month subcutaneous formulation has received EU approval and U.S.
PDUFA is set for the 12th of September. Again, this is 2 times per year, 10 minutes to treat your MS. We expect that Ocrevus subcut represents an incremental CHF2 billion in sales opportunity and we expect this to be increasingly visible in the coming quarters as we are already starting to see some strong pickup in our very early launch countries in the EU.
.....
And again, we are very much focused on the conversion into Phesgo, which provides a lot of stickiness and that we would fully expect Phesgo conversion to be above 50% in many markets.
Bruno Eschli
Okay. Then we move on. The next one would be Simon Baker of Redburn. Simon?
Simon Baker
Thanks very much, Bruno, for taking my questions. Two if I may please. Firstly, Teresa, you mentioned on Tecentriq subcutaneous, the strong reception that's received in the UK. The other strongly received subcutaneous formulation in the UK recently has been Ocrevus, according to the media, there have been suggestions that there is very considerable demand for Ocrevus subcut. So I was just wondering if you could give us an idea of how generalizable that UK experience is? I know the UK has a particular passion for subcut formulations. And what does this mean for Ocrevus subcutaneous beyond the UK, across the world? And do you see maybe the US, ex-US sales split, balancing up between now that we get to a subcut formulation?...
Teresa Graham
Absolutely. And when we look -- so it's a great question on Tecentriq subcut. So I think that in terms of the UK experience, we saw great uptake with Phesgo. We've seen strong uptake with Tecentriq subcut. I think that is quite generalizable for the UK market. I think anything that removes patients from having to go into the system and allows them to go home or to get a faster infusion or a faster injection, that actually frees up chair time and frees up office time, those are going to be very attractive to the UK system, and frankly, attractive to any system that's under financial pressure, which is most global healthcare systems around the world. So I think this is why we are again, really doubling down on devices going forward.
In terms of the Ocrevus subcut, I do believe that bringing the subcut formulation to Europe and to the rest of the world will provide additional opportunities for Ocrevus to reach patients. The initial out-of-the-gate orders for Ocrevus in those countries that have the ability to move quite quickly after approval are already quite strong. Again, you'll start to see the sales for Ocrevus play out of in the coming quarters. But I think this could be something that does equalize that US, EU, rest of world balance as we start getting reimbursement for Ocrevus subcut around the world.
Again, we think that in and of itself, it's a USD2 billion opportunity. And so that's USD2 billion on top of what we've already gotten from the IV space. So this isn't just going to be about cannibalizing our IV business. This is going to be about both in the US and outside the US, expanding to new patient pools. It's very attractive on the Ocrevus side. Just to control expectations a little bit, on the Tecentriq side, I know I mentioned it in my presentation, but we think with Tecentriq, it's largely going to be a conversion strategy. And so that's probably about an incremental USD200 million upside for Tecentriq, while the opportunity for Ocrevus, we believe, is much, much larger.
Simon Baker
Yeah. That was really, really helpful. Just one very quick follow-on going back to Ocrevus subcutaneous. And if you just remind us what the IP situation is? It looks like it's patent-protected to September 2030, but any additional comment on that would be really helpful?
Teresa Graham
Yeah. So I think clearly Ocrevus is sort of end of the decade, but we shouldn't make any broad, sweeping statements about where we think that might go with new formulations and new doses."
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