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

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Now with regard to the spread on the revenue, I’ll let Eli take that and I think your comments are about you understand the FX, you understand the biosimilars, but what else is driving that. So Eli, if you could help you clarity there?

Eli Kalif : Yes. So Balaji, thanks for the question. Yes, when you drive the kind of range when you start the year, you look on — mostly on programs that require risk adjustments. So in addition to Humira in the U.S. generics, we have a few of them that risk adjusted. So they might come and be better than what we expect. So this is part of that range and also the solid business that we have with Europe generics and OTC even considering, I would say, the average of current run rate in ’22 that we see this one, also with a great potential. So this is — those two elements, I would say, also part of those range.

Operator: We will now take our next question. This is from the line of Elliot Wilbur from Raymond James.

Elliot Wilbur : Maybe I could ask Sven to just follow up on the last question with respect to sort of the range of possibilities within the North American Generics segment in 2023 and specifically thinking about new product launch opportunities. If there’s anything you can highlight in terms of date certain items or launches with certainty pursuant to settlements, and then maybe specifically just some of the complex generics that could enter the equation in 2023? I know we’ve — I feel like we’ve been talking about teriparatide and cyclosporine for three presidential administrations here. And obviously, the FDA has been slow on complex generics, but any additional clarity you could add there with respect to the new product dynamic in 2023 would be helpful.

And then for Richard, outside of the reiteration of the company’s prior long-term financial targets, wondering if the strategic review or the updated strategic plan, in fact, could modify any of those parameters and thinking specifically about the 2027 debt-to-EBITDA target of 2x. Certainly seems like financial markets, equity holders will be much more comfortable with a higher leverage ratio, 2.5x to 3x and if they were comfortable with the company’s use of discretionary capital in terms of pursuing pipeline enhancement initiatives in additional strategic investments. So I’m wondering if there’s maybe some flexibility, particularly with respect to that parameter would free up quite a bit of cash flow for reinvestment into pipeline and longer-term growth assets

Richard Francis : Thanks for the two questions, Elliot, So look, I’ll go in the order you deliver them. So I’ll ask Sven to answer one around the almost complex generics approvals that you’ve been experiencing through the last three presidential campaigns.

Sven Dethlefs : Yes. So the usual suspects — thanks for the question, Elliot. So U.S. generics this year, overall, we’ll see a weak patent expiring year. So this year doesn’t have a lot of, let’s say, launches that are naturally driven by patent expiry dates. It will be more driven by FDA approvals and settlement entries. As you also pointed out, Humira, we already talked about. For TO, we received this year that we answered to the FDA. We are working with them closely to sort out this issue. Just as a reminder, this product has been launched many years ago in Europe already with EMA approval and we know how to manufacture it, of course. And I believe the product is high quality and that we will get the FDA around to give us approval.

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