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

Page 3 of 10

And what we focused on and what we’ll continue to focus on is complex generics. Now obviously, they have unpredictability. But when you do get into the market, they are very profitable and sustainable. So I think for me, it’s not so much about getting back to a revenue number. So in that making sure you have a GX business that is profitable, predictable and allows you to get growth in the right areas. And that comes back to profitability. But I’ll hand over to Sven to give his view on those two questions.

Sven Dethlefs : Thanks, Gary. I think you were interested in Humira market formation and the benefit of interchangeability. So in what concerns market formation, I think we will go through three phases. Phase 1 is right now because Amgen already entered the market with a non-interchangeable Humira biosimilar. Then we have the next inflection point, which will be our market entry it’s July 1. And then we see a clear transition towards biosimilars with the formulary changes that come in 2024. So there will be basically three phases for the Humira market formation. I believe we are well positioned. We have discussions with all our customers on the July 1 date. Our customers very well recognize the importance of interchangeability, and I believe it has become even more important since FDA has guided to this year staying on formulary.

And if you have , the originator on formulary, of course, you need an interchangeable biosimilar to really drive uptake of biosimilar generics in this space. And we also did recently market research on the question of pull-through with pharmacists and HCPs. And here, we also saw that interchangeability is actually well known in this professional community and especially HCPs look for interchangeability designation when writing a biosimilar other than Humira. So I believe, overall, our product profile is quite strong. We have high concentration, citrate-free interchangeable product. We are working towards FDA approval. And for that reason, I believe we can participate in this Phase 2 market formation starting in July. And adding to Richard’s comments about the complex generics of the U.S. generics business and our run rate, so the run rate was $3.75 billion in 2021 and $3.55 billion in 2022.

Our focus is now this year on creating a Humira success and, of course, to bring more complex generics to the market because what we’ve seen in our portfolio is despite the hurdles that you have for FDA approval with complex generics, they show themselves to be very resilient and drive longer-term value and especially when we look at our gross margin structure, you can see how important complex generics became over the last years. So for this year, we talk about, especially Forteo as an opportunity, Xulane as a second opportunity and then the other complex generics that we also talked about in the previous years, such as RESTASIS or Sandostatin. And then we have a couple of other complex generics in the pipeline potentially to be launched in 2023 if we get FDA approval.

Operator: We’ll now take our next question. This is from the line of Glen Santangelo from Jefferies.

Page 3 of 10