Takeda Pharmaceutical Company Limited (NYSE:TAK) Q3 2023 Earnings Call Transcript

We are starting with MSA, because it’s a more streamlined Phase 2 and Phase 3 study. We think that we can see efficacy more rapidly in MSA. But we are also considering very seriously moving into Parkinson’s disease as well. And then finally, this program is a partnership with AstraZeneca. The terms of the partnership were that AstraZeneca would manage the Phase 1 program, and starting in Phase 2 and Phase 3, Takeda would take over the market authorization application. Thank you.

Operator: Thank you. The next question is JPMorgan. Wakao-san, please.

Seiji Wakao: Wakao speaking, JPMorgan. Thank you very much. I have two questions. First is TYK2 EBITDA. In March, Phase 2b result will be announced. And looking at this Phase 2b results compared to deucravacitinib of Bristol, can we tell that this is superior? Phase 2 endpoint is, I think PASI 75 and compared to deucravacitinib, can we consider that it is expected that this Nimbus molecule is superior? That’s first question. Second question is about 861. You proceeded to Phase 2. And in TAK-994, there are some safety setbacks, but can you now believe that it’s totally eliminated, or still there is potentially a possibility of the similar risk in Phase 2 and you will monitor it? And I think it is for long-acting molecule. However, in terms of the concept, is it the similar sort of molecules?

Christopher O’Reilly: Thank you. I think both of these for Andy as well. So, the first question on the TYK2 inhibitor. So, we will see Phase 2b data in March. And will that data allow us to see superiority versus the Bristol product in the PASI 75 scores? And then the second question on TAK-861. Does this mean that we have fully overcome the TAK-994 safety issues, or does that possibility remain in Phase 2? And previously, we talked about this €“ about having a longer half-life, a longer duration. And is that still the case with TAK-861? Over to you, Andy?

Andy Plump: So, the TYK2 Phase 2b psoriasis €“ I am sorry, the TYK2 Phase 2b psoriasis data will €“ Nimbus has already disclosed if they intend to present that in March. The hope is that we will be closing the deal this fiscal year, and we will be presenting those data or representing those data at a medical meeting. It’s important to note the study did not include deucra. This was a study that was increasing doses of what we will call TAK-279 against placebo. So, you have to make cross-study comparisons. And when we looked at the data during our diligence, we felt that the study data suggested a high likelihood of a best-in-class profile. The best way to understand the potential of this molecule is to go back and look at some of the deucra Phase 2b data, right.

And look at what you see in terms of clinical efficacy with increasing doses with deucra and then look at the dose that was chosen for Phase 3. So, we believe that deucra left efficacy on the table with their Phase 3 dose, perhaps to optimize the safety profile. But you will have an opportunity to see all of those data next month. With respect to TAK-861, TAK-861 is a distinct molecule to TAK-994. It’s more potent. It has a longer half-life. It’s a very different set of biophysical properties, and it’s dosed at a much lower level than TAK-994 to see equivalent efficacy. We haven’t seen any indication of liver toxicity in our clinical studies. Now, it’s important to note that we have only dosed patients for up to four weeks, but we haven’t seen any signals, which is quite encouraging.

So, we are very excited to move forward with the Phase 2b study, which we will be testing a number of different doses and dose combinations.

Operator: Thank you very much. Moving on to the next question, Morgan Stanley, Mr. Muraoka, please.

Shinichiro Muraoka: Hello. This is Muraoka, Morgan Stanley. I hope you can hear my voice.

Christopher O’Reilly: Yes, we can hear you.