Teva Pharmaceutical Industries Limited American Depositary Shares FDA announcement

Good morning and good afternoon, everyone. Thank you for joining us on short notice to discuss the U.S. FDA approval of WELTRUZA, olanzapine LAI. The materials are posted to the website this morning, and the press release is also on our website. Before I turn the call over to Richard Francis, I would like to remind everyone that we will be making forward-looking statements on the call. The company cautions investors that any forward-looking statement involves risks and uncertainties and is not a guarantee of future performance. Actual results may differ materially from those expressed or implied in the forward-looking statement due to a variety of factors. These factors are described in our earnings press release and our most recent forms 10-K and 10-Q filed with the SEC.

Any statements that we make are only valid as of today, and we undertake no obligation to update those statements subsequently. With that, Richard, the floor is yours.

Thank you, Chris. Thank you everybody for joining the call. On the call today will be Eric Hughes, Head of R&D, Chief Medical Officer. For the Q&A, I will be joined by Chris Fox, the EVP, Executive Vice President of U.S. Commercial, and Eddie Ghaeli, Chief Financial Officer. Moving on to the next slide. The next slide, please. Once again, it is great to be having a call with you where we talk about the execution of our Pivot to Grow strategy, a strategy we started back in 2023. A strategy that was designed to move Teva from a pure play, world-class generics company to a world-class biopharmaceutical company. I think we have made incredible progress. If you remember, it was a three-phase strategy. The first was to return to growth. We have done that over the last three years. The second phase was to accelerate growth.

That acceleration was going to come to delivering on our growth engines, our innovative products that we have in the market that we often talk about. It was also about really bringing an exciting pipeline to the market. I am really excited today that we are in a position where we can start to talk about that step-up innovation, and see our pipeline start to materialize. If you go on to the next slide, 2026 has already been a year of acceleration, you could say. We have had a number of milestones already this year. The dupilumab maintenance data, the ecopipam accepted by the FDA and given priority review, the anti-IL-15 you saw some data in vitiligo, and recently in Celiac disease. Today is all about WELTRUZA. It is a special day for patients, for physicians, and for families that some of their members have schizophrenia.

As Teva, we are really proud to be able to bring WELTRUZA to the market to help this patient population in coping with that condition. So exciting for us at Teva. Exciting that it is a year where we keep bringing new data, new opportunities to drive this long-term acceleration of Teva. With that, I know everybody is excited to hear about the data, so I will hand over to Eric.

Thank you, Richard. I really appreciate it. If I could have the first slide. I have to start off by saying we are just delighted by the approval of WELTRUZA by FDA. I just wanted to start off by saying, this begins with the patient. Patients with schizophrenia, it is a devastating disease for patients, and it can be a devastating disease for their families as well. The most important thing is that we do have treatments for schizophrenia. What WELTRUZA will bring, we hope, is that chance of decreasing relapses, because we are going to take advantage of the long-acting injectable for them. This relentless progression, negative, positive cognitive symptoms over years, we want to prevent those relapses, which would cause the hospitalizations and cause the progression of their disease.

We have thought about the patient from day one, and we believe that we are really achieving a great thing for them today. Can I have the next slide? This patient population is not insignificant. There are 2.2 million people in the U.S. About 1.5 million of them get treated, and 20% of all those patients who get treated are on oral olanzapine. Olanzapine is a known treatment for schizophrenia. It has powerful efficacy and a known safety profile. Our Teva commercial organization is set up to succeed here. We have a deep understanding of the patient journey, which is very complex. We have been doing and detailing these patients, and caregivers with our UZEDY program, and we are building upon that great expertise. As I mentioned, olanzapine has a demonstrated safety profile, and we have go-to-market capabilities that are, I think, leading in the industry.

But let's get to the WELTRUZA on the next slide. WELTRUZA really epitomizes the R&D strategy at Teva. We choose unmet medical needs that need to be addressed. We innovate based on the formulation. We brought and built upon the known safety and efficacy of WELTRUZA. We innovated with the formulation by design to differentiate it for the market. We executed the study with high velocity by accelerating the program 6-9 months, and that brought in an on-target submission, which then led to an approval that was right first time. This is our plan. This is how we build upon known science and accelerate it, to bring a treatment for unmet need in patients. We're very proud of this, and I think this is a winning paradigm for our company. Go to the next slide.

So what gets us so delighted and elated at Teva this morning? WELTRUZA builds upon the known efficacy and safety of olanzapine. I said this is a tried and true treatment for schizophrenia, and as I mentioned, that's 20% of the oral market right now for patients. But we innovated on it. We brought a once-monthly subcutaneous dose that this has no loading dose, no oral supplementation, and no post-injection monitoring. These are the critical attributes of what we needed to achieve, and we delivered on that completely with this label that we have gotten approved by the FDA. So I'm very proud of the work that the R&D organization has done and the work that we're collaborating with our commercial colleagues to make sure that we get this treatment to patients as quickly as possible. We're very excited by all the results that we've achieved to date.

And this really fills a long-standing gap in care. There are no other alternatives for long-acting injectables that are viable, compared to WELTRUZA. So we think that we really are addressing an unmet medical need with the innovations from our labs. Go to the next slide. And I want to bring it back to the patient on this last slide. I said that the most important thing is preventing relapse. That's what long-acting injectables continuously show, that when you get rid of the problem of adherence. Adherence is the problem of breakthrough and relapse with these powerful drugs. By bringing an easily used subcutaneous injection that's once a month, we're chipping away at that adherence problem. And you can see in our follow-on study from SOLARIS in Period 2 out to about a 1 year follow-on, only 4% of the patients relapse.

This is a critical element of what we want to help patients do. Get a treatment that's easy to use, well-known, and efficacious, but take away that problem of adherence with a subcutaneous injection once a month. We're very proud of this. We have great hope for patients in the future, and we're looking forward to getting this out as widely as possible. And with that, Richard, I will hand it back to you.

Thank you, Eric. Thank you for walking through that. We finish on this slide. I just want to give you a bit of context for this slide. This is the image that you will be seeing around with regard to WELTRUZA. We are doing a DTC campaign with WELTRUZA, and we're doing this because we believe that we have created a real opportunity for these patients, as Eric has mentioned, and the physicians to start treating their patients differently with this molecule. To do that, we want to make sure people are aware of it. Those physicians are aware of it, patients are aware of it, their loved ones are aware of it. So it gives them the chance to get back into that office and have a discussion with their physician. The physicians are also aware of it.

So be prepared to see this, and for many of you who know us, this builds on the capability that we built with Austedo, where we had to re-mobilize a patient population with tardive dyskinesia and help physicians start to treat those patients differently for the first time in a long time. So, good capabilities that Eric mentioned we already have in schizophrenia, but good capabilities around how do we mobilize this patient population to help them understand there is a new treatment out there. With that, I will now open it up for Q&A.