Teva Pharmaceutical Industries Limited (NYSE:TEVA) Q4 2022 Earnings Call Transcript

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Sven Dethlefs : Okay. Humira, our plan and the risk adjustment that we took, I think that was the topic. So first of all, we plan as having an interchangeable product in July, so that we get approval for it. Just as a reminder, the weekly process by the FDA for the interchangeable Humira from our partner, Alvotech, has been concluded and the outstanding issue for approval is now the site inspection that was scheduled for March 6. So we expect if the site inspection will be successful, we get approval for both BLAs that are with the FDA. The guidance that we have. So is there an upside? Of course, there’s an upside if we sign all the contracts, and we have a limited number of competition within these contracts. We are quite confident that we can generate pull-through because of the product profile.

But we have to wait and see for the next step, and I would say we take it step by step. We’re quite confident in approval. We also are quite confident in our ability to supply the market with the required volumes. So that’s all on track.

Richard Francis : Jason, I know that we were down for — it’s okay, is that what you need?

Jason Gerberry : Yes. Thanks.

Operator: So we’ll now move to our next question. This is from Balaji Prasad from Barclays.

Balaji Prasad : Richard, you have articulated the importance of biosimilars for Teva over the next few years. And as I look at the long-term guidance that you provided of mid-single digits, I want to understand the role of specialty segments within this, especially as we look at the pipeline and the late-stage assets in specialty as parts? And secondly, coming to this year’s guidance, excluding FX and biosimilar Humira, are there any other major variables which influenced the $600 million revenue or $400 million EBITDA spread?

Richard Francis : Thanks for the question. I’ll take the first part and then maybe tag team with Eli on the second part. So I think your question was around sort of drive growth to our specialty portfolio going forward. So let me sort of touch a bit upon that. I think I highlighted within the call already that the opportunity we still see around AUSTEDO and AJOVY, particularly when you look about the patient numbers that that still are not being treated, I think the opportunity is significant to bring that therapy to a lot more patients. So I see that as a major driver and AJOVY as a driver that can probably be worthwhile outside the U.S. as we expand more into Europe and the international market because of the introduction of the oral therapies into the U.S. But then I will touch upon the pipeline as well.

So you said the risperidone product, we have olanzapine, that product that’s gone into Phase 3 clinical trials. So I think — and then we have our innovative pipeline which we’ll talk about midyear, which I see more as the medium term. But excited about it. I think that could bring some significant growth going forward, obviously, if that gets through the clinical development phase. So I think we have a number of assets already. And that’s not mentioned some of the complex generics that Sven spoke about earlier, which we’re still waiting for FDA approval. So I think we’re well positioned with our pipeline across specialty, biosimilars and complex generics. Obviously, the challenge always is making sure we get those to markets in a timely fashion, and that’s what we’re going to be working hard on.

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