Q3 2023 Teva Pharmaceutical Industries Ltd Earnings Call
Operator: Hello and welcome to the Q3 2023 Teva Pharmaceutical Industries earnings Conference call. My name is Alex there'll be coordinating the call today. If you'd like to ask a question at the end of the presentation, you can press star, followed by one on your telephone keypad. If you'd like to remove it, you may press star followed by two. I'll now hand you to your host, Ran Meir, SVP of investor relations. Please, go ahead.
I'd like to ask a question at the end of the presentation you compress style led by one on your telephone keypad.
If you'd like to remove it you May press star two.
How do you hope to your highest Rodman <unk> SVP of Investor Relations. Please go ahead.
Ran Meir: Thank you, Alex. Thank you, everyone for joining us today. We hope you had an opportunity to review our press release, which was issued earlier this morning. A copy of this press release, as well as a copy of the slides being presented on this call, can be found on our website at tevapharm.com.
We hope you all have an opportunity to review our press.
The release, which was issued earlier this morning.
Okay.
A copy of the slides presented on this call can be found on our website. They have a farm that calls.
Ran Meir: Please review our forward-looking statements on Slide number 2. Additional information regarding these statements and our non-GAAP financial measures is available on our earnings release and in our SEC Forms 10-K and 10-Q. To begin today's call, Richard Francis, Teva's CEO, will provide an overview of Teva's Q3 results and business performance, recent events, and our priorities going forward.
Additional information regarding these statements and our non-GAAP financial measures is available on our earnings release and in our SEC Form 10-K, and thank you.
To begin today's call <unk> will provide an overview of debit.
In digital format.
Recent events and priorities going forward.
Ran Meir: Then, Dr. Eric Hughes, our head of R&D and Chief Medical Officer, will discuss progress on our innovative pipeline. Our CFO, Eli Kalif, will follow up by reviewing the financial results in more detail, including our 2023 financial outlook. Joining Richard, Eric, and Eli on the call today is Sven Dethlefs, Teva's head of North America business, who will be available during the question-and-answer session that will follow the presentation. Please note that today's call will run approximately one hour. And with that, I will now turn the call over to Richard. Richard.
Chief Medical Officer will discuss progress on our pipeline.
Our CFO Ed it'll lead to follow up by reviewing the financial results in more detail, including our FY2023 financial outlook.
Joining Richard Eric and Andy on the call today is David at the end of North America business and will be available during the question and acquisition that we follow the presentation.
Please note that today's call. We ran approximately one hour and with that I will now turn the call over to Richard Richard.
Richard Francis: Thank you, Ran, and thank you, everybody, for joining us today. I'd like to begin by saying that we are deeply saddened by the terror attacks in Israel on October the 7th. Since that day, Teva's board, leadership team, and I have made the safety and well-being of our Israeli colleagues our utmost priority. I visited and met employees at the facilities in Israel immediately after the attack.
I'd like to begin by saying that we are deeply saddened by the terror attacks in Israel on October the seventh.
Since that data of his board leadership team and I have made the safety and wellbeing of Israeli colleagues utmost priority.
I visited and met employees of the facilities in Israel immediately after the attack.
Richard Francis: Many of them have families and friends who have perished or been kidnapped. What really stood out and inspired me was that despite all the difficulties, they are rallying together to bring medicines to the patients who need them, especially now. I am personally humbled by their incredible resilience, care, and sense of purpose. Now, we have increased support of our emergency supply of medicines to hospitals, pharmacies, and patients, and we have partnered with our long-standing partners to donate products and provide other humanitarian aid.
He stood out and inspired me was despite all the difficulties they are running together to bring medicines to the patients who need them, especially now.
I have personally humbled by the incredible resilience.
And sense of purpose.
Now we've increased support of our emergency supply of medicines to hospitals pharmacies and patients and we have partnered with our long standing partners to donate products and provide other humanitarian aid.
Richard Francis: Through it all, our production remains largely unaffected, and gratefully, none of our sites have incurred direct damage as a result of the war. We continue to secure contingency plans to be certain we can maintain our business continuity, while, most importantly, taking care to ensure that our colleagues are safe and well in these difficult times. Now, moving on to Slide 5, I'd like to update you on strong performance in Q3, as we continue to execute our pivot to growth strategy. Now, our strong performance of our growth was delivered by our growth engines, Austedo, Ajovy, and our generics business.
We continue to secure contingency plans to be certain we can maintain our business continuity.
Most importantly, taking care to ensure that our colleagues are safe and well in these difficult times.
Now moving on to slide five I'd like to update you on <unk>.
Strong performance in Q3, as we continued to execute our pivot to growth strategy.
Now I will start with performance of our growth was delivered by our growth engines, instead of the JV and our generics business.
Richard Francis: Revenues were up 7% in U.S and in local currency. Our gross margin continues to improve. We saw it increase by 50 basis points versus Q3 2022. We are pleased to announce the exciting partnership with Sanofi in Q3, the deal to really maximize anti-TL1A asset. Because of these results, I'm pleased to announce that we're going to increase our outlook of revenue to 15.1 billion to 15.5 billion for 2023. Now, to move on to the next slide to continue to maybe update you on our pivot to growth strategy. As you all remember, this was based on four pillars: delivering on growth engines, step up innovation, sustain our generics powerhouse, and focus our business.
Richard Francis: Revenues were up 7% in U.S and in local currency. Our gross margin continues to improve. We saw it increase by 50 basis points versus Q3 2022. We are pleased to announce the exciting partnership with Sanofi in Q3, the deal to really maximize anti-TL1A asset. Because of these results, I'm pleased to announce that we're going to increase our outlook of revenue to 15.1 billion to 15.5 billion for 2023.
Our gross margin continues to improve.
We sold increased by 50 basis points versus Q3 2022.
We are pleased to announce exciting partnership with Sanofi in Q3, the deal to really maximize our tier one asset.
Okay.
Because of these results I'm pleased to announce that we can increase our outlook of revenue to $15 one to $15 5 billion for 2023.
Richard Francis: Now, to move on to the next slide to continue to maybe update you on our pivot to growth strategy. As you all remember, this was based on four pillars: delivering on growth engines, step up innovation, sustain our generics powerhouse, and focus our business.
Now we went to the next slide to continue to maybe update you on our pivot to growth strategy.
As you will remember this was based on four pillars.
To deliver on our growth engines step up innovation.
Sustaining generics powerhouse and focus our business.
Richard Francis: So, we're just going to touch on some of the progress we've made in Q3. As I've just mentioned, Austedo is performing well and is on track to hit 1.2 billion for 2023, and we remain committed and confident of hitting the target of 2.5 billion in 2027. Uzedy was launched earlier in the year, and I'll give you an update on that. And we're pleased to announce with our partner Alvotech that we're doing an FDA inspection in early Q1 in 2024.
As I've just mentioned are setup is performing well and is on track to hit $1 2 billion for 2023.
We remain committed and confident of hitting the target of $2 5 billion in 2027.
You said he was launched earlier in the year I will give you an update on that and we're pleased to announced with our partner Alphatec that with you in an FDA inspection in early Q1 in 2024.
Richard Francis: Raises the opportunity that we might be able to launch Humira next year. With regard to innovation of joined on this call by a Qs youll get some more detail, but a couple of highlights are obviously around olanzapine a long acting treatment for schizophrenia phase III study. This is progressing really well and ahead of schedule. So we're confident we'll be able to report results in that in the second half of next year. Two questions. Talbot generics powerhouse, we made good progress and as Youll see we have growth across all of our regions.
Richard Francis: It raises the opportunity that we may be able to launch Humira next year. With regard to innovation, I'm joined on this call by Eric Hughes, who'll go into more detail, but a couple of highlights are obviously around olanzapine, our long-acting treatment for schizophrenia in a phase 3 study. This is progressing really well and ahead of schedule, so we're confident we'll be able to report results in that in the second half of next year. To have a generics powerhouse, we made good progress.
Richard Francis: It raises the opportunity that we may be able to launch Humira next year. With regard to innovation, I'm joined on this call by Eric Hughes, who'll go into more detail, but a couple of highlights are obviously around olanzapine, our long-acting treatment for schizophrenia in a phase 3 study. This is progressing really well and ahead of schedule, so we're confident we'll be able to report results in that in the second half of next year.
With regard to innovation of joined on this call by a Qs youll get some more detail, but a couple of highlights are obviously around olanzapine a long acting treatment for schizophrenia phase III study. This is progressing really well and ahead of schedule. So we're confident we'll be able to report results in that in the second half of next year.
Two questions.
Richard Francis: To have a generics powerhouse, we made good progress, and as you will see, we have growth across all of our regions. And then finally, on pillar four, focus our business, we continue to do the work to create a stand-alone business unit for Tapi and pleased to announce the appointment of our CEO for that business, that allows them to compete in the global market. And moving on to the next slide, just to touch upon one of the news we had in Q3, that exciting collaboration with Sanofi. I'm pleased with this collaboration because it really strengthens our pivot to growth strategy.
Talbot generics powerhouse, we made good progress and as Youll see we have growth across all of our regions.
Richard Francis: and as Youll see we have growth across all of our regions.
And then finally on pillar four focus of our business.
We continue to do the work to create a standalone business unit. The taffy I'm pleased to announce the appointment of a CEO for that business that allows them to compete in the global market.
And moving onto the next slide.
Just to touch upon one of that that the news we had in Q3 of exciting collaboration with Sanofi.
I'm pleased with this collaboration because it really strengthens our pivot to growth strategy.
Richard Francis: It allows us to partner with a global leader in immunology, both from an R&D and commercial perspective, while retaining 50% of the economics going forward, which is important, as we want to drive long-term growth for Teva. We see this asset as an asset that can drive long-term growth because of the size of the market we'll be operating in. I'll come to that a bit later on. Now, back to performance, on the next slide.
We see this asset is an asset that can drive.
Long term growth because of the size of the market will be operating it and I'll come to that a bit later on.
Now back to performance on the next slide.
Richard Francis: As I said, we had strong performance in Q3. Revenue was 3.9 billion, up 7%. That was driven by both our innovative business, as well as our generics business. Austedo continued its impressive growth, up 30%, while Ajovy continues to grow well at 22%. Pleased to show that we saw growth across all of our regions, with particularly strong performance in the U.S and international markets. Now, to double-click and dive a bit deeper, I'd like to move on to Austedo. Austedo, once again, we confirm that we're committed to the US$1.2 billion target for 2023.
<unk> continued its impressive growth up 30%, while Adobe continues to grow well at 22%.
Richard Francis: Pleased to show that we saw growth across all of our regions, with particularly strong performance in the U.S and international markets. Now, to double-click and dive a bit deeper, I'd like to move on to Austedo. Austedo, once again, we confirm that we're committed to the US$1.2 billion target for 2023.
Now the Doubleclick and dive a bit deeper I would like to move onto a setup.
Instead of once again, we confirm that committed to the $1 2 billion target for 2023.
Richard Francis: Revenue was up, the US$339 million for Q3, up 30%, and supported and underpinned by good strong TRx growth of 29%. Now, on the next slide, I want to reiterate our commitment to the US$2.5 billion target for 2027. We're doing this by investing in our brand and building capability in the company. As we mentioned earlier in the year, we have increased our sales force, we have invested in improving our patient support services, as well as looking to launch this brand into the European market by 2026.
Now on the next slide I want to reiterate our commitment to the $2 5 billion target for 2027.
We are doing this by investing in our brand and building capability of the company.
As we mentioned earlier in the year, we have increased our sales force we have invested.
Improving our patient support services as well as looking too.
Launched this brand into the European market by 2026.
Richard Francis: Now, we see the opportunity not only because we're investing in building capability, but there's a significant unmet medical need, when it comes to patients suffering from tardive dyskinesia. And tragically, there's a lot of patients who still need to benefit from Austedo, so, we have work to do there and an ability to improve patients' lives. Now, moving on to the next slide, Ajovy. We're on track to reach or even exceed the US$400 million for 2023, with good growth in Q3 and revenues of US$114 million.
Tragically there is a lot of patients who still need to benefit from instead of so we have work to do that.
Each improve patients' lives.
Now moving onto the next slide Adobe.
We are on track to reach or even exceed the $400 million for 2023 with good growth in Q3 revenues of $114 million.
Richard Francis: As I said, revenue - sorry, as I said, growth was 22%. What I like about Ajovy is not the fact that we're just growing in all of our regions, but we remain very competitive in what is a competitive sector and segment of the market, highlighting our sales and marketing and medical and commercial capabilities. Now, moving on to the next slide. The newest member of our innovative family is Uzedy, a long-acting treatment for risperidone, launched in May of this year.
Now moving on to the next slide the newest member of our innovative family is setting a long acting treatment for spirit launched in May of this year.
Richard Francis: Now we're pleased with the launch. As you can see you said, it's capturing over 55% of all NPR acts in the spirit of the long acting market. And this is driven by. The strong feedback. <unk> from physicians and patients physicians patients. Obviously appreciate the subcutaneous injection versus intramuscular and I think the physicians find the fact that you said he can which reached therapeutic doses within six months to 24 hours to be really helpful. When they're treating patients who have a relapse. This market is an attractive market, it's a $4 billion market and we think you said he will have a real.
Richard Francis: Now, we're pleased with the launch. And as you can see, Uzedy is capturing over 55% of all NBRX in the risperidone long-acting market, and this is driven by the strong feedback we're receiving from physicians and patients. Patients, obviously, appreciate the subcutaneous injection versus intramuscular, and I think the physicians find the fact that Uzedy can reach therapeutic doses within six to 24 hours to be really helpful when they're treating patients who have a relapse. This market is an attractive market.
As you can see you said, it's capturing over 55% of all NPR acts in the spirit of the long acting market.
And this is driven by.
The strong feedback.
<unk> from physicians and patients physicians patients. Obviously appreciate the subcutaneous injection versus intramuscular and I think the physicians find the fact that you said he can which reached therapeutic doses within six months to 24 hours to be really helpful. When they're treating patients who have a relapse.
This market is an attractive market, it's a $4 billion market and we think you said he will have a real.
Richard Francis: It's a US$4 billion market, and we think Uzedy will have a real part to play in that market. Now, as I've said before, 2023 is a setup year for 2024. We need to make sure we get access, formulary inclusions in our hospitals, and we're making very good progress on that. So, look forward to updating you on Uzedy as we near the end of the year.
To play in that market now as I've said before 2023 is a setup for 2024.
We need to make sure we get access formulary inclusion in our hospitals and we're making very good progress on that.
So look forward to updating you on your study.
As we near the end of the year.
Richard Francis: Now, moving away from our innovative portfolio to our generics business. And as I said earlier, I'm pleased to show that we're growing our generics business across all of our regions, U.S included. And as you can see, strong growth in the U.S at 15%, solid growth in Europe, and good growth in emerging markets and local currencies of 17%. Now, to move on to our pipeline, which is obviously a key pillar of our strategy, our pivot to growth strategy and step up innovation, just to look at the late stage assets we have. I've talked about olanzapine and how encouraged we are with the recruitment of our patients into that phase III trial. And we look to be announcing - Eric and his team will look to be announcing those results in the second half of next year.
Richard Francis: Now, moving away from our innovative portfolio to our generics business. And as I said earlier, I'm pleased to show that we're growing our generics business across all of our regions, U.S included. And as you can see, strong growth in the U.S at 15%, solid growth in Europe, and good growth in emerging markets and local currencies of 17%.
Failure to our generics business and as I said earlier I'm pleased to share that we've grown in our generics business across all of our regions.
U S included and as you can see strong growth in the U S, 15% solid growth in Europe, and good growth in emerging markets in local currencies of 17%.
Richard Francis: Now, to move on to our pipeline, which is obviously a key pillar of our strategy, our pivot to growth strategy and step up innovation, just to look at the late stage assets we have. I've talked about olanzapine and how encouraged we are with the recruitment of our patients into that phase III trial. And we look to be announcing - Eric and his team will look to be announcing those results in the second half of next year.
Now.
To move on to our pipeline, which is obviously a key pillar of <unk>.
Strategy, a pivot to growth strategy and step up innovation.
Just to look at the late stage assets, we have I've talked about olanzapine.
<unk>.
I would encourage we are with the recruitment of patients into that phase III.
Trial, and we look to be announcing what Eric and his team will look to be announcing those results in the second half of next year. Once again to reiterate this is a significant market and with Olanzapine that really isn't a satisfactory and long acting version of this product. This molecule in the market. So we are excited about this and the help we can bring to this.
Trial, and we look to be announcing what Eric and his team will look to be announcing those results in the second half of next year.
Richard Francis: Once again to reiterate this is a significant market and with Olanzapine that really isn't a satisfactory and long acting version of this product. This molecule in the market. So we are excited about this and the help we can bring to this. Patient population. Moving onto Ics Saba. Another product that entered phase III clinical trials in Q3, we started to acute patients already. This is a significant opportunity as I mentioned on previous calls.
Richard Francis: Once again, to reiterate, this is a significant market. And with olanzapine, there really isn't a satisfactory and long-acting version of this product, this molecule in the market, so, we're excited about this and the help we can bring to this patient population. Moving on to ICS/SABA, another product that entered phase III clinical trials in Q3. We've started to recruit patients already, and this is a significant opportunity.
Patient population.
Moving onto Ics Saba.
Another product that entered phase III clinical trials in Q3, we started to acute patients already.
This is a significant opportunity as I mentioned on previous calls.
Richard Francis: as I mentioned on previous calls. Based on the guidelines in the U S. There are 10 million patients who should be on in Ics have a combination and so if you just take 30% of the market is still significant significantly to 5 billion. So a real opportunity to continue to drive growth to Teva. Business. And then finally. <unk> spoken a bit about it but I'm sure Eric will touch on this as well, but just to highlight the size of the opportunity in UC and CD, which we see is around $28 billion for what we think we have a best in class products.
Richard Francis: As I mentioned on previous calls, based on the guidelines in the U.S, there are 10 million patients who should be on an ICS/SABA combination. And so, if you just take 30% of these, the market is still significant at US$2.5 billion. So, a real opportunity to continue to drive growth for Teva in our innovative business. And then finally, on anti-TL1A, I've spoken a bit about it, and I'm sure Eric will touch on this as well.
Based on the guidelines in the U S. There are 10 million patients who should be on in Ics have a combination and so if you just take 30% of the market is still significant significantly to 5 billion. So a real opportunity to continue to drive growth to Teva.
Business.
And then finally.
<unk> spoken a bit about it but I'm sure Eric will touch on this as well, but just to highlight the size of the opportunity in UC and CD, which we see is around $28 billion for what we think we have a best in class products.
Richard Francis: but just to highlight the size of the opportunity in UC and CD, which we see is around $28 billion for what we think we have a best in class products. Sure. And then in my final slide I'd, just like to close out with our recent progress on our ESG strategy and initiatives. In Q3, we made good progress in executing our ESG strategy and we made good progress against some of our ESG targets. And I'm pleased to announce on behalf of the team for the company. Some awards, we were winner of the Best Company ESG reporting in the health care sector.
Richard Francis: But just to highlight the size of the opportunity in UC and CD, which we see is around US$28 billion for what we think we have a best-in-class product. And then on my final slide, I'd just like to close out with our recent progress on our ESG strategy and initiatives. In Q3, we made good progress on executing our ESG strategy and we made good progress against some of our ESG targets. And I'm pleased to announce on behalf of the team that the company received some awards.
Sure.
And then in my final slide I'd, just like to close out with our recent progress on our ESG strategy and initiatives.
In Q3, we made good progress in executing our ESG strategy and we made good progress against some of our ESG targets.
And I'm pleased to announce on behalf of the team for the company.
Some awards, we were winner of the Best Company ESG reporting in the health care sector.
Richard Francis: We were the winner of the best company for ESG reporting in the healthcare sector and also in 2023 Best Corporate Social Responsibility initiative. So, really highlighting the work and the progress we've made on our ESG strategy. Now, with that, I would like to hand over to my colleague, Eric Hughes, who will walk you through some of our pipeline news.
And also in 2023, best corporate social social responsibility initiatives.
Highlighting the work and the progress we've made on our ESG strategy.
Now with that I would like to hand over to my colleague <unk>, who will walk you through some of our pipeline use.
Eric A. Hughes: Thank you, Richard. Can I have the next slide? So, as Richard mentioned, we're excited by the improved sales of Austedo, which is a testament to Austedo's safety and efficacy. To build upon what we've already achieved with Austedo, we want to make sure that the flexibility and the convenience of Austedo is improved with our patients, and we're happy to present this data from our real-world studies called Start. This study was a real-world study to look at how our four-week titration pack is used.
So.
As Richard mentioned, we're excited by the improved the improved sales at a steady which is a testament to a set of safety and efficacy.
<unk>.
To build upon what we've already achieved a instead of we want to make sure that the flexibility and the convenience of a setup has improved with our patients and we are happy to.
Present, this data from our real World studies called start.
This study was a real world study to look at how our four week titration pack is used what.
Eric A. Hughes: What we see in this study is that 78% of the subjects completed the study, 97% were adherent to the medication, 76% reached the optimal dose, and 95% reached a dose greater than 24 milligrams per day. But why is this important? Well, the important thing is to get patients on the right dose that's optimal for them, use the flexibility of Austedo, and maintain patients on effective treatment. And you can see that in this study, we had actually a very good response rate in the abnormal involuntary movement scale of about 4.8, which is actually numerically better than our pivotal studies. So, we believe with the titration pack, the flexibility of the dosing, and these adherence rates that we see in our Start study, we will maximize the ability of patients to receive and obtain the proper dose and stay on treatment.
Eric A. Hughes: What we see in this study is that 78% of the subjects completed the study, 97% were adherent to the medication, 76% reached the optimal dose, and 95% reached a dose greater than 24 milligrams per day. But why is this important? Well, the important thing is to get patients on the right dose that's optimal for them, use the flexibility of Austedo, and maintain patients on effective treatment.
Inherent to the medication 76 reached the optimal dose and 95% are reached a dose greater than 24 milligrams per day.
But why is this important well the important thing is to get patients on the right dose that's optimal for them use the flexibility of our setup and maintain patients on effective treatment and you can see that in this study we had actually a very good response.
Eric A. Hughes: And you can see that in this study, we had actually a very good response rate in the abnormal involuntary movement scale of about 4.8, which is actually numerically better than our pivotal studies. So, we believe with the titration pack, the flexibility of the dosing, and these adherence rates that we see in our Start study, we will maximize the ability of patients to receive and obtain the proper dose and stay on treatment.
The response rate and the abnormal involuntary movement scale of about four eight which is actually a numerically better than our pivotal studies. So we believe with the titration pack the flexibility of the dosing and these adherence rates that we see in our start study, we will maximize the ability of patients to receive and obtain the proper.
Does it stay on treatment.
Eric A. Hughes: Got it excellent. Yes. As Richard mentioned, we're also excited to see the improvement improved sales of Adobe Adobe is a. A program that we have for migraine and we can recapitulate, our phase II or phase III studies. And its effect on the monthly migraine days that we improve so in this study called unite. Prospective study, but the uniqueness of this study was that we looked at patients with migraine, who also had a depressive symptoms and this is important because depression of the comorbidity with migraine.
Eric A. Hughes: Come next slide. As Richard mentioned, we're also excited to see the improved sales of Ajovy. Ajovy is a program that we have for migraine, and we can recapitulate our phase III studies and its effect on the monthly migraine days that we improve. So, in this study called Unite, that's a prospective study, but the uniqueness of this study was that we looked at patients with migraine who also had depressive symptoms.
Yes.
As Richard mentioned, we're also excited to see the improvement improved sales of Adobe Adobe is a.
A program that we have for migraine and we can recapitulate, our phase II or phase III studies.
And its effect on the monthly migraine days that we improve so in this study called unite.
Prospective study, but the uniqueness of this study was that we looked at patients with migraine, who also had a depressive symptoms and this is important because depression of the comorbidity with migraine.
Eric A. Hughes: and this is important because depression of the comorbidity with migraine. Chronic migraine increasing. Increased disabilities and decreases in quality of life. So we designed unite to. Prospectively look at both the effects on monthly migraine treatment and as well as depressive symptoms and we're pleased to show that the primary endpoint was achieved in recapitulated are good results and the monthly migraine rates, but also in the secondary endpoint on depressive symptoms. So this is the first study to show in fact that we have a significant effect not only on monthly migraine, but also on depressive symptoms and of CERP either subcutaneous oral so very excited to see this I think there is a great benefit to patients.
Eric A. Hughes: And this is important because depression is a comorbidity with migraine that leads to chronic migraine, increased disabilities, and decreases in quality of life. So, we designed Unite to prospectively look at both the effects on monthly migraine treatment and as well as depressive symptoms. And we're pleased to show that the primary endpoint was achieved and recapitulated our good results in the monthly migraine rates, but also in the secondary endpoint on depressive symptoms. So, this is the first study to show, in fact, that we have a significant effect, not only on monthly migraine, but also on depressive symptoms in a CGRP, either subcutaneous or oral.
Eric A. Hughes: And this is important because depression is a comorbidity with migraine that leads to chronic migraine, increased disabilities, and decreases in quality of life. So, we designed Unite to prospectively look at both the effects on monthly migraine treatment and as well as depressive symptoms. And we're pleased to show that the primary endpoint was achieved and recapitulated our good results in the monthly migraine rates, but also in the secondary endpoint on depressive symptoms.
Chronic migraine increasing.
Increased disabilities and decreases in quality of life. So we designed unite to.
Prospectively look at both the effects on monthly migraine treatment and as well as depressive symptoms and we're pleased to show that the primary endpoint was achieved in recapitulated are good results and the monthly migraine rates, but also in the secondary endpoint on depressive symptoms.
Eric A. Hughes: So, this is the first study to show, in fact, that we have a significant effect, not only on monthly migraine, but also on depressive symptoms in a CGRP, either subcutaneous or oral. So, we're very excited to see this. I think there's a great benefit to patients. Come to the next slide. Now, we're also excited to present more data on Uzedy from our pivotal studies and the sub analysis.
So this is the first study to show in fact that we have a significant effect not only on monthly migraine, but also on depressive symptoms and of CERP either subcutaneous oral so very excited to see this I think there is a great benefit to patients.
Eric A. Hughes: so very excited to see this I think there is a great benefit to patients. Got it excellent. Now we're also excited to present more data on <unk> from our pivotal studies and the sub analysis and the rise study our pivotal study we looked at the disease duration across all the patients that we enroll and here you can see that we had patients that were less than five years, all the way up to greater than 20 years.
Eric A. Hughes: So, we're very excited to see this. I think there's a great benefit to patients. Come to the next slide. Now, we're also excited to present more data on Uzedy from our pivotal studies and the sub analysis.
Got it excellent.
Now we're also excited to present more data on <unk> from our pivotal studies and the sub analysis and the rise study our pivotal study we looked at the disease duration across all the patients that we enroll and here you can see that we had patients that were less than five years, all the way up to greater than 20 years.
Eric A. Hughes: and the rise study our pivotal study we looked at the disease duration across all the patients that we enroll and here you can see that we had patients that were less than five years, all the way up to greater than 20 years. And why is this stuff analysis important well there is the thought that after many years of greater than 20 years. Treatment of schizophrenia, schizophrenia becomes slightly resistant to treatment, but here, we can see that clearly there is no impact on disease. Duration on the effectiveness of the Zurich, so greater than 20 years is very good.
Eric A. Hughes: In the Rise study, our pivotal study, we looked at the disease duration across all the patients that we enrolled. And here you can see that we had patients that were less than five years, all the way up to greater than 20 years. And why is this sub analysis important? There is the thought that after many years of, you know, greater than 20 years, the treatment of schizophrenia becomes slightly resistant to treatment. But here we can see that, clearly, there's no impact on disease duration on the effectiveness of Uzedy.
And why is this stuff analysis important well there is the thought that after many years of greater than 20 years.
Treatment of schizophrenia, schizophrenia becomes slightly resistant to treatment, but here, we can see that clearly there is no impact on disease.
Duration on the effectiveness of the Zurich, so greater than 20 years is very good.
Eric A. Hughes: So, greater than 20 years is a very good populations, have shown treatment effect then. Equally as important is those patients that are less than five years duration of their treatment. Here, again, even in this population, which has a higher relapse rate early in treatment, we also had a great effect, which is important because in LAIs - this is a continuing theory that LAIs are an effective way of starting treatment. Thank you.
Populations have shown treatment affect them.
As important as those patients that are less than five years.
Duration of their treatment share again, even in this population, which has a higher relapsed rate early in treatment.
We also had a great effect, which is important because it like.
This is a continuing theory that <unk> are an effective way of starting treatment.
Thank you for the question.
Eric A. Hughes: Next slide, please. Now, Richard mentioned the olanzapine LAI study. You know, it's going very well. We've enrolled over 550 patients to date. And I just want to review quickly what the study design is for our phase 3 program. We do have three doses against placebo for eight weeks to the primary endpoint, and then we'll roll those subjects over into three doses again for up to 48 weeks to build our safety database. The study has enrolled very quickly, and I'll go over a timeline of the readout, but we're excited to see that a study enrolls quickly. This is obviously a testament to the capabilities of the R&D organization, as well as the desire of investigators to use an injectable olanzapine.
Eric A. Hughes: Next slide, please. Now, Richard mentioned the olanzapine LAI study. You know, it's going very well. We've enrolled over 550 patients to date. And I just want to review quickly what the study design is for our phase 3 program. We do have three doses against placebo for eight weeks to the primary endpoint, and then we'll roll those subjects over into three doses again for up to 48 weeks to build our safety database.
Now Richard mentioned, the Olanzapine study, it's going very well we've enrolled over 550 patients to date.
And I just wanted to review quickly what the study design is for our phase III program.
We do have three doses against placebo for eight weeks to the primary endpoint and then we will roll those subjects over into three doses again for an up to 48 weeks to build our safety database.
This study has enrolled very quickly.
Eric A. Hughes: The study has enrolled very quickly, and I'll go over a timeline of the readout, but we're excited to see that a study enrolls quickly. This is obviously a testament to the capabilities of the R&D organization, as well as the desire of investigators to use an injectable olanzapine.
Ill go over timelines of the readout, but we're excited to see that study enrolls quickly. This is obviously a testament to the capabilities of the R&D organization as well as the.
The desire of investigators to use an injectable once a team.
Eric A. Hughes: Come to the next slide. Finally, I just want to touch base on our TL1A program. Richard mentioned that we had a deal signed with Sanofi to advance this very important product forward. As I've mentioned many times in the past, this is a very important underserved market.
Finally, I just wanted to touch base on our <unk> program that Richard mentioned that we had.
Deal.
Signed with Sanofi to advance this very important product forward.
As I've mentioned many times in the past is a very important underserved market.
Eric A. Hughes: Over 4 million patients diagnosed about $2 7 million of treated however, the treatments are have good effect that only last for so long people frequently cycle through treatments and many of these patients actually end up still getting surgery. Disease progresses, so more treatments are important in this disease area. We believe we have the best in class potential for <unk>, we have a potent compound with great selectivity. We've shown good safety in our asthma study and we've shown low antidrug antibodies to date.
Eric A. Hughes: There's over 4 million patients diagnosed, about 2.7 million are treated. However, the treatments have good effects that only lasts for so long. People frequently cycle through treatments. And many of these patients actually end up still getting surgery as their disease progresses.
Eric A. Hughes: So, more treatments are important in this disease area. We believe we have the best-in-class potential for TL1As. We have a potent compound with great selectivity. We've shown good safety in our Asthma study, and we've shown low antidrug antibodies to date.
Disease progresses, so more treatments are important in this disease area. We believe we have the best in class potential for <unk>, we have a potent compound with great selectivity. We've shown good safety in our asthma study and we've shown low antidrug antibodies to date.
Eric A. Hughes: The collaboration with Sanofi is going to capitalize on the potential of this target. This target has the potential to go across many different disease indications. It's a pre-atrophic cytokine that affects many different pathways. So, the possibilities are large for this group.
Capitalize on the potential of this target. This target has the potential to go across many different disease indications.
We are trophic cytokines it affects many different pathways. So the possibilities are.
Our large for this group.
Eric A. Hughes: As I've mentioned, we've accelerated the program, and we're putting all our effort on getting our interim analysis read out in 2024. So, looking forward to more in collaboration with Sanofi. And just to review our milestones in development, so, I mentioned TL1A, we're moving forward and we're putting resources and investment in making sure that we achieve our interim analysis in the second half of 2024. I have been talking about olanzapine LAI and its acceleration.
We're putting all our effort on getting our interim analysis read out in 2024.
So looking forward to more in collaboration with Sanofi.
And just to review our milestones and development. So I mentioned Gona, we're moving forward as we were putting our resources and investment in making sure that we achieve our interim analysis within the second half of 2024.
I had been talking about the lines between <unk> and its acceleration.
Eric A. Hughes: We have been reporting that we were going to report the results out in the first half of 2025, but I'm happy to say we've accelerated that to the second half of 2024. We've enrolled patients in our anti-IL15 PoC study for celiac disease, and we will have our PK from our SAD and MAD studies coming up in the second half of 2024. We are well on our path to have our first patient dosed in our anti-PD1-IL2 program in the first half of 2024 when we submit our IND. And as Richard mentioned, ICS/SABA has now launched into our phase 3 program, and we're looking for results in the first half of - or second half of 2026.
Eric A. Hughes: We have been reporting that we were going to report the results out in the first half of 2025, but I'm happy to say we've accelerated that to the second half of 2024. We've enrolled patients in our anti-IL15 PoC study for celiac disease, and we will have our PK from our SAD and MAD studies coming up in the second half of 2024. We are well on our path to have our first patient dosed in our anti-PD1-IL2 program in the first half of 2024 when we submit our IND.
Reporting that we were going to report the results out in the first half of 2025, but I'm happy to say, we've accelerated that to the second half of 2024, we've enrolled patients in our anti IL 15, POC study for celiac disease, and we will have our PK from our BN <unk> study is coming out in the second half of 2010.
Fourth we are well on our path to have our first patient dosed in our NTP one IL two program in the first half of 2004, when we submit our indeed and as Richard mentioned Ics Saba has now launched into our phase III program and we're waiting for our results in first half of our second half of 2020. So.
Eric A. Hughes: And as Richard mentioned, ICS/SABA has now launched into our phase 3 program, and we're looking for results in the first half of - or second half of 2026. So, lots of things going on. I'm glad to see that we're accelerating our programs and keeping to our timelines. And with that, I'm going to pass it off to Eli.
Lots of things going on I am glad to see that we're accelerating our programs and keeping to our timelines and with that I'm going to pass it off to <unk>.
Eli Kalif: Thank you, Eric, and good morning and good afternoon to everyone. I'll begin my review of our Q3 2023 financial results with Slide 25, starting with our GAAP performance. Revenues in the third quarter of '23 were 3.9 billion, representing an increase of 7% compared to Q3 2022, both in reported terms and in local currency. To provide you some color on our revenue performance by region, in North America, we had overall strong performance with 11% growth in Q3 2023 compared to third quarter last year.
Begin my review of our Q3 2023 financial result, with slide 25.
Starting with our GAAP performance.
Revenues in the third quarter of 2000.
Three 9 billion, representing an increase of 7% compared to Q3 2022, both in reported terms and in local currency.
To provide you some color on our revenue performance by region.
In North America with overall strong performance with 11% growth in Q3, 2023 compared to third quarter last year.
Eli Kalif: This growth was mainly driven by higher revenue from generics products, Austedo, and Ajovy, partially offset by lower revenue from Bendeka and Treanda. As Richard mentioned, revenues in our generics business in North America increased by 15% in Q3 2023, mainly due to revenues from generics revenues, partially offset by an increase in competition to other generics products. Revenues in our Europe segment were flat in local currency terms. We continue to see strong growth in Ajovy and a solid growth in our generics business in the third quarter.
And Adobe, partially offset by lower revenue from the Nick entry ended.
As Richard mentioned revenue in our generic business in North America increased by 15% in Q3 2023 made you drew revenues from generic revenue, partially offset by increased competition to other generic products.
Revenues in our Europe segment were flat in local currency terms, we continue to see strong growth in Adobe and solid growth in our generic business in the third quarter.
Eli Kalif: This was, however, largely offset by lower revenues from our legacy brands, including Copaxone. Revenues from our international market segment increased by 20% in local currency terms. This was mainly driven by higher revenue from our generics product, largely coming from price increases as measure to offset higher costs due to inflationary pressures. This increase was partially offset by regulatory price reduction and generic competition to off-patent products in Japan.
Revenues from our international market segment increased by 20% in local currency terms. This was mainly driven by higher revenue from our generic products largely coming from price increases as measure to offset higher costs due to inflationary pressures distinct.
This increase was partially offset by regulatory price reductions and generic competition to off patent products in Japan.
Eli Kalif: GAAP operating income was US$365 million in the third quarter of 2023, compared to an operating income of US$419 million in the third quarter of 2022. The lower operating income in the third quarter of 2023 was mainly due to higher legal settlements and loss contingencies, higher R&D and S&M expenses, partially offset by higher gross profit. Our higher R&D expenses in the third quarter of 2023 compared to the third quarter of 2022 were mainly due to an increase to support our late-stage innovation pipeline that Richard and Eric mentioned earlier, in line with our pivot to growth strategy. In addition, last year and in the third quarter of 2022, our R&D expenses were lower due to an adjustment in payments related to a contract with one of our R&D partners.
Eli Kalif: GAAP operating income was US$365 million in the third quarter of 2023, compared to an operating income of US$419 million in the third quarter of 2022. The lower operating income in the third quarter of 2023 was mainly due to higher legal settlements and loss contingencies, higher R&D and S&M expenses, partially offset by higher gross profit.
The lower operating income in the third quarter of 2053 was mainly due to higher legal settlement and loss contingencies.
R&D and <unk> expenses.
Expenses, partially offset by higher gross profit.
Eli Kalif: Our higher R&D expenses in the third quarter of 2023 compared to the third quarter of 2022 were mainly due to an increase to support our late-stage innovation pipeline that Richard and Eric mentioned earlier, in line with our pivot to growth strategy. In addition, last year and in the third quarter of 2022, our R&D expenses were lower due to an adjustment in payments related to a contract with one of our R&D partners.
Our higher R&D expenses in the third quarter of 2023 compared to the third quarter of 2020 due for mainly due to an increase to support our late stage innovation pipeline of 300, and Eric mentioned earlier in.
In line with our pivot to growth strategy.
In addition last year in the first quarter of 2022, our R&D expenses were lower due to an adjustment in payments related to a contract with one of our R&D partners.
Eli Kalif: We also saw an increase in our S&M expenses compared to the third quarter last year, mainly due to promotional activities related to Austedo and Uzedy, as well as exchange rate fluctuations in our Europe segment. We had a GAAP income of US$80 million, compared to the net income of US$56 million in Q3 2022; and a GAAP earnings per share of US$0.07, compared to GAAP earnings per share of US$0.05 in the same period a year ago. The higher net income in the third quarter of 2023 was mainly due to reduced tax expenses in 2023 compared to Q3 2022. Our tax rate in Q3 2023 was mainly affected by increased deferred tax assets resulting IP-related integration plans.
Eli Kalif: We also saw an increase in our S&M expenses compared to the third quarter last year, mainly due to promotional activities related to Austedo and Uzedy, as well as exchange rate fluctuations in our Europe segment. We had a GAAP income of US$80 million, compared to the net income of US$56 million in Q3 2022; and a GAAP earnings per share of US$0.07, compared to GAAP earnings per share of US$0.05 in the same period a year ago.
When a GAAP income of $80 million compared to the net income of $56 million in Q3 2022.
GAAP earnings per share of <unk> <unk> compared to GAAP earnings per share of <unk> in the same period a year ago.
The higher net income in the third quarter of 2023 was mainly due to reduced tax expenses in 2023 compared to Q3 2022.
Eli Kalif: The higher net income in the third quarter of 2023 was mainly due to reduced tax expenses in 2023 compared to Q3 2022. Our tax rate in Q3 2023 was mainly affected by increased deferred tax assets resulting IP-related integration plans.
Our tax rate in Q3, 2023 was mainly affected by increased deferred tax asset, resulting IPO related integration plan.
Eli Kalif: Such integration plans have been adopted, among others, in an effort of addressing the global adoption of OECD Pillar Two minimum effective corporate tax commencing in 2024. The increase in our net income was partially offset by lower operating income, as discussed above. Foreign exchange rate movements during the third quarter of 2023, net of hedging effects, negatively impacted our revenues and GAAP operating income by 9 million and 53 million, respectively, compared to the third quarter of 2022. This was primarily a result of the impact of stronger U.S. dollars against currencies of certain international markets in which we operate, partially offset by the benefit from euro appreciation. Approximately 46% of our revenue in Q3 2023 came from sales denominated in non-U.S. dollar currency. Turning to Slide 26.
Eli Kalif: Such integration plans have been adopted, among others, in an effort of addressing the global adoption of OECD Pillar Two minimum effective corporate tax commencing in 2024. The increase in our net income was partially offset by lower operating income, as discussed above. Foreign exchange rate movements during the third quarter of 2023, net of hedging effects, negatively impacted our revenues and GAAP operating income by US$9 million and US$53 million, respectively, compared to the third quarter of 2022.
<unk> in 2024.
The increase in our net income was partially offset by lower operating income as discussed above.
Foreign exchange rate movement during the third quarter of 2023 net of hedging effects negatively impacted our revenue and GAAP operating income by $9 million and $53 million, respectively compared to the third quarter of 2022.
This was primarily a result.
Eli Kalif: This was primarily a result of the impact of stronger U.S dollars against currencies of certain international markets in which we operate, partially offset by the benefit from euro appreciation. Approximately 46% of our revenue in Q3 2023 came from sales denominated in non-U.S dollar currency. Turning to Slide 26.
The impact of a stronger U S dollar against currencies of certain international market in which we operate partially offset by the benefits from euro depreciation.
<unk>, 46% of our revenue in Q3 2003 came from sales denominated in non us dollar currency.
Turning to slide 26.
Eli Kalif: You can see that the total non-GAAP adjustment in the third quarter of 2023 were approximately US$598 million, compared to US$602 million in Q3 2022. Notable GAAP adjustment this quarter include legal settlements, loss contingencies of US$314 million, mainly related to estimated provision recorded in connection with certain litigation cases in the U.S. Additional notable adjustments included amortization of purchased intangible assets of US$145 million, the majority of which is included in cost of sale. Now, moving to Slide 27 for review of our non-GAAP performance.
The provision recorded in connection with certain litigation cases in the U S and.
Additional notable adjustments included amortization of purchased intangible assets are financed 145 million. The majority of which is included in cost of sale.
Now moving to slide 27 for a review of our non-GAAP performance.
Eli Kalif: As I mentioned, our third quarter revenue were totaled approximately US$3.9 billion, representing growth of 7% compared to the third quarter of 2022. Now, let's move down to the P&L, starting with the gross profit margin. Our non-GAAP gross profit margin was 53.5% in the third quarter of 2023, compared to 53% in Q3 2022. This improvement in non-GAAP gross profit margin was mainly driven by several mix of products, including higher revenue from Austedo in our North America segment, partially offset by higher costs due to inflationary and other macroeconomic pressures.
Now lets move down to the P&L, starting with gross profit margin.
Our non-GAAP gross profit margin was 53, 5% in the third quarter of 2023 compared to 53% in Q3 2022. This improvement in non-GAAP gross profit margin was mainly driven by favorable mix of products, including higher revenue from our data and our north.
America segment, partially offset by higher costs due to inflationary and other macroeconomic pressures.
Eli Kalif: As I mentioned last quarter and as expected, this was an approximate 130-basis-point sequential improvement in our non-GAAP gross profit margin in Q3 2023 compared to the second quarter of 2023. This sequential improvement in gross margin was driven by continuing to shift toward a more normalized portfolio mix, mainly driven by strong growth in Austedo, continued growth in Ajovy, as well as improvement in our cost of goods sold due to the expected easing of the inflationary pressures and other measures we are taking to drive productivity in our supply chain. Our non-GAAP operating margin in Q3 2023 was 26.5%, versus 27.2% in Q3 2022. This decrease in operating margin was mainly due to an increase in R&D expenses, partially offset by higher gross profit margins, as I just mentioned, as well as lower G&A expenses.
Eli Kalif: As I mentioned last quarter and as expected, this was an approximate 130-basis-point sequential improvement in our non-GAAP gross profit margin in Q3 2023 compared to the second quarter of 2023. This sequential improvement in gross margin was driven by continuing to shift toward a more normalized portfolio mix, mainly driven by strong growth in Austedo, continued growth in Ajovy, as well as improvement in our cost of goods sold due to the expected easing of the inflationary pressures and other measures we are taking to drive productivity in our supply chain.
Profit margin in Q3, 2000, <unk> 53, compared to the second quarter of 2023.
This sequential improvement in gross margin was driven by continuous shift towards a more normalized portfolio mix, mainly driven by strong growth in data.
Continued growth in Adobe as well as improvement in our cost of goods sold due to the expected easing of the inflationary pressures and other measures we are taking to drive productivity in our supply chain.
Our non-GAAP operating margin in Q3, 2023 was 26, 5% versus 27, 2% in Q3 2022.
Eli Kalif: Our non-GAAP operating margin in Q3 2023 was 26.5%, versus 27.2% in Q3 2022. This decrease in operating margin was mainly due to an increase in R&D expenses, partially offset by higher gross profit margins, as I just mentioned, as well as lower G&A expenses.
This decrease in operating margin was mainly due to an increase in R&D expenses, partially offset by higher gross profit margin as I, just mentioned as well as lower G&A expenses.
Eli Kalif: We ended the third quarter with a non-GAAP earnings per share of US$0.60, compared to US$0.59 in Q3 2022, mainly due to a higher non-GAAP operating income, partially offset by higher financial expenses in Q3 2023. Now, let's take a look at our spend based on Slide 28. As you can see, our quarterly spend base increased by US$213 million or US$171 million on a local currency basis. This increase was due to a higher cost of goods sold related to higher revenue compared to the third quarter of 2022, as well as higher operating expenses related to higher R&D and S&M that I just mentioned earlier, partially offset by efficiencies in our G&A expenses.
Eli Kalif: We ended the third quarter with a non-GAAP earnings per share of US$0.60, compared to US$0.59 in Q3 2022, mainly due to a higher non-GAAP operating income, partially offset by higher financial expenses in Q3 2023. Now, let's take a look at our spend based on Slide 28. As you can see, our quarterly spend base increased by US$213 million or US$171 million on a local currency basis.
Now, let's take a look at our spend based on slide 28.
As you can see.
Quarterly fan base increased by $213 million or $171 million on a local currency basis. This increase was due to a higher cost of goods sold related to a higher revenue compared to the third quarter of 2022, as well as higher operating expenses related to higher R&D and <unk>.
Eli Kalif: This increase was due to a higher cost of goods sold related to higher revenue compared to the third quarter of 2022, as well as higher operating expenses related to higher R&D and S&M that I just mentioned earlier, partially offset by efficiencies in our G&A expenses.
Just mentioned earlier.
Partially offset by efficiencies in our G&A expenses.
Eli Kalif: As we move forward, we expect our operating expenses to be approximately from US$1 billion to US$1.05 billion in the fourth quarter, including a quarterly run rate of R&D expenses to be in the range of US$230 million to US$250 million as we continue to progress our pipeline, including the late-stage innovative asset. This is in line with our pivot to growth strategy to position the business for long-term growth and success. Turning to free cash flow on Slide 29. In the first three quarters of 2023, we generated US$0.9 billion of free cash flow versus US$1.1 billion during the same period last year, a decrease of US$200 million.
This is in line with our pivot to growth strategy to position the business for long term growth and success.
Turning to free cash flow on slide 29.
In the first three quarters of 2023, we generated <unk> 9 billion of free cash flow versus $1 1 billion. During the same period last year, a decrease of $200 million.
Eli Kalif: This resulted mainly from changes in working capital items, including an average higher inventory level as well as lower net income as a result of lower gross profit and higher operating and finance expenses. Today, we are reaffirming our 2023 free cash flow guidance, our 2023 free cash flow is expected to be in the range of one seven to $2 1 billion. Our fourth quarter free cash flow expectation include a sequential ramp up in our revenue and profitability with a meaningful contribution from <unk>. In addition, we continue to drive working capital improvement, including significant inventory efficiencies and continuation of the positive impact from accounts payable as a result of.
Eli Kalif: This resulted mainly from changes in working capital items, including, on average, higher inventory levels, as well as lower net income as a result of lower gross profit and higher operating and finance expenses. Today, we are reframing our 2023 free cash flow guidance. Our 2023 free cash flow is expected to be in the range of 1US$.7 billion to US$2.1 billion. Our fourth quarter free cash flow expectation includes a sequential ramp-up in our revenue and profitability, with a meaningful contribution from Austedo.
Today, we are reaffirming our 2023 free cash flow guidance, our 2023 free cash flow is expected to be in the range of one seven to $2 1 billion.
Our fourth quarter free cash flow expectation include a sequential ramp up in our revenue and profitability with a meaningful contribution from <unk>. In addition, we continue to drive working capital improvement, including significant inventory efficiencies and continuation of the positive impact from accounts payable as a result of.
Eli Kalif: In addition, we continue to drive working capital improvements, including significant inventory efficiencies and continuation of the positive impact from accounts payable as a result of expansion in our vendor payment program, which we launched earlier this year. This free cash flow outlook range does not include the first upfront milestone payment payable to us under the exclusive collaboration with Sanofi for our anit-TL1A, which we announced in October. Turning to Slide 30. Our net debt at the end of Q3 2023 was US$17.7 billion, compared to US$18.4 billion at the end of 2022.
Expansion in our vendor payment program, which we launched earlier this year.
This free cash flow outlook range does not include the first upfront milestone payments stable to us under the exclusive collaboration with Sanofi for our anti <unk>, which we announced in October.
Turning to slide 30.
Our net debt at the end of Q3, 2023 was $17 7 million compared to $80 4 million at the end of 2022.
Eli Kalif: Our gross debt was US$20 billion, compared to US$21.2 billion at the end of 2022. The decrease in our gross debt was mainly due to US$1.6 billion senior notes repaid at maturity and US$54 million of exchange rate fluctuation, partially offset by US$500 million outstanding under the revolving credit facility as of September 30, 2023. As I mentioned last quarter, in July 2023, we withdrew a total amount of US$700 million under our US$1.8 billion revolving credit facility. The proceeds of which were used to repay 1 billion of our senior notes at maturity in July.
The decrease in our gross debt was mainly due to $1 6 billion senior notes repaid at maturity and $64 million of exchange rate fluctuation, partially offset by $500 million outstanding under the revolving credit facility as of September 32023.
As I mentioned last quarter.
In July 2023, we withdraw a total amount of $700 million under our $1 8 billion revolving credit facility.
The proceeds of which were used to repay $1 billion of our senior notes at maturity in July.
Eli Kalif: In September 2023, we repaid US$200 million. And as of today, US$500 million is outstanding under the revolving credit facility. Our net debt to EBITDA improved compared to Q2 2023, coming now at 4.03 times for Q3 2023 due to foreign exchange rate movements, as well as free cash flow generation in the third quarter. As part of our capital allocation strategy, debt reduction continues to be our focus, and we expect to continue to work toward our long-term financial target of being two times net debt to EBITDA by end of 2027.
Our net debt to EBITDA improved compared to Q2 2023 coming now at four three times for Q3 2003 due to foreign exchange rate movement as well as free cash flow generation in the third quarter.
As part of our capital allocation strategy debt reduction continues to be our focus and we expect to continue to work toward our long term financial target of being two times net debt to EBITDA by end of 2027.
Eli Kalif: Turning to Slide 31, which presents our upcoming debt maturities. As I mentioned, we have already repaid US$1 billion of our 2.8% senior notes at maturity in July 2023. So, there are currently no additional maturity payments due in 2023. Following our successful refinancing of approximately US$2.5 billion of our debt through our sustainability-linked senior notes during the first quarter of 2023, we have aligned our near-term debt maturities with our annual free cash flow guidance for this year.
Which presents our upcoming debt maturities.
As I mentioned, we have already repaid $1 billion of two 8% senior notes at maturity in July 2023. So there are currently no additional maturity payments do instrument inventory.
Following our successful refinancing of approximately $2 5 billion of our debt through the ability.
Of note during the first quarter of 2023, we have aligned our near term debt maturities with our annual free cash flow guidance for this year.
Eli Kalif: We believe we are well positioned to continue to serve our debt and with these upcoming maturities over the next couple of years with our ongoing cash flow generation. Now, turning to our 2023 non-GAAP outlook on Slide 32. As Richard highlighted earlier, we had a solid third quarter and year-to-date performance, in terms of our revenues across all regions. This includes continued strong momentum in our key growth engines, especially Austedo, continued growth in Ajovy, as well as solid performance in our core generics business globally.
Now turning to our 2023 non-GAAP outlook on slide 32.
As Richard highlighted earlier, we had a solid third quarter and year to date performance in terms of our revenue across all regions. This includes continued strong momentum in our key growth engine, especially with.
Continued growth in the jewelry as well as solid performance in our core generics business globally.
Eli Kalif: In addition, we're seeing relatively higher revenue from copaxone compared to our initial expectation. Which we now expect it to be approximately $550 million for the full year. Terrific. This revenue performance in the first nine months, along with the expected development in the fourth quarter. We're increasing our full year revenue guidance range by $100 million. Now expected our revenue to be between $15 1 billion. $50 5 million four and the full year of 2023. We also continue to expect sequential improvement in our margin. In the fourth quarter as previously communicated we are driving and continue the shift in our portfolio mix, mainly driven by strong growth in <unk> as well as further improvement in our cost of goods sold.
Eli Kalif: In addition, we are seeing relatively higher revenue from Copaxone, compared to our initial expectation, which we now expect it to be approximately US$550 million for the full year. To reflect this revenue performance in the first nine months, along with the expected development in the fourth quarter, we are increasing our full year revenue guidance range by US$100 million. We are now expecting our revenue to be between US$15.1 billion to US$15.5 billion for and the full year of 2023. We also continue to expect sequential improvement in our margins in the fourth quarter.
Which we now expect it to be approximately $550 million for the full year.
Terrific. This revenue performance in the first nine months, along with the expected development in the fourth quarter.
We're increasing our full year revenue guidance range by $100 million.
Now expected our revenue to be between $15 1 billion.
$50 5 million four and the full year of 2023.
We also continue to expect sequential improvement in our margin.
Eli Kalif: As previously communicated, we are driving and continuing the shift in our portfolio mix, mainly driven by strong growth in Austedo, as well as further improvement in our cost of goods sold. To reflect our year-to-date tax performance that I referred earlier, we are now expecting our annual non-GAAP tax rate for the full year 2023 to be in the range of 12% to 15%, and we expect our fully diluted share count to be approximately 1.132 billion shares for the full year of 2023. Today, we are also reaffirming our 2023 non-GAAP outlook for operating income, EBITDA, earnings per share, and free cash flow as provided in February. I want to reiterate that our full year revenue, operating income, adjusted EBITDA, diluted EPS, and free cash flow outlook ranges do not include the first upfront milestone payment payable to us under the exclusive collaboration with Sanofi for our anti-TL1A, which we announced in October.
Eli Kalif: As previously communicated, we are driving and continuing the shift in our portfolio mix, mainly driven by strong growth in Austedo, as well as further improvement in our cost of goods sold. To reflect our year-to-date tax performance that I referred earlier, we are now expecting our annual non-GAAP tax rate for the full year 2023 to be in the range of 12% to 15%, and we expect our fully diluted share count to be approximately US$1.132 billion shares for the full year of 2023.
In the fourth quarter as previously communicated we are driving and continue the shift in our portfolio mix, mainly driven by strong growth in <unk> as well as further improvement in our cost of goods sold.
To reflect our year to date tax performance.
That I referred earlier.
Now expected our annual.
Annual non-GAAP tax rate for the full year 2023 to be in the range of 12% to 15%.
And we expect our fully diluted share count to be approximately $1. One 2 billion shares for the full year of 2023.
Eli Kalif: Today, we are also reaffirming our 2023 non-GAAP outlook for operating income, EBITDA, earnings per share, and free cash flow, as provided in February. I want to reiterate that our full year revenue, operating income, adjusted EBITDA, diluted EPS, and free cash flow outlook ranges do not include the first upfront milestone payment payable to us under the exclusive collaboration with Sanofi for our anti-TL1A, which we announced in October. With that, this concludes my review of Teva's results for the third quarter of 2023. And now, I will hand it back to Richard for a summary.
Today, we are also reaffirming our 2023 non-GAAP outlook for operating income EBITDA earnings per share and free cash flow is provided in February.
I want to reiterate that our full year revenue operating income adjusted EBITDA diluted EPS and free cash flow outlook ranges do not include the first upfront milestone payments payable to us.
Exclusive collaboration with Sanofi for <unk>, which we announced in October.
Eli Kalif: With that, this concludes my review of Teva's results for the third quarter of 2023. And now, I will hand it back to Richard for a summary.
This concludes my review of the of our results for the third quarter of 2023, and now back to Richard for a summary.
Richard Francis: Thank you, Eli, and thank you, Eric. So, in summary, strong Q3 performance, driven by Austedo, the launch of Uzedy and Ajovy, and good performance across our generics business in all three regions. To that, as you heard from Eli, we're increasing our guidance for revenues for this year. And I'm pleased to show that the pivot to growth strategy is starting to get traction, as I've highlighted with Austedo, the collaboration TL1A, with the capability build that Eric and his team have done that allowed us to accelerate olanzapine, our long-acting product in phase III study, as well as with the Teva api with the recruitment of our CEO. With that, I'll hand it over to people to ask questions.
The launch of the <unk>.
Josie.
Performance across our generics business.
Three regions.
Is that as you're familiar we are increasing our guidance for revenues this year.
I'm pleased to show that the pivot to growth strategy is starting to get traction.
As I've highlighted with instead of the collaboration till <unk> with.
With the capability build that Eric and his team have done this allowed us to accelerate olanzapine, although that team productivity phase III studies as well as with the Teva API the equivalent of <unk>.
With that I'll hand, it over to people to ask questions.
Operator: Thank you. As a reminder, if you'd like to ask a question, you can press star followed by one on your telephone keypad. If you'd like to remove your question, you may press star followed by two. Please make sure you aren't muted locally when asking your question. Our first question for today comes from Umer Raffat of Evercore ISI. Your line is now open. Please, go ahead.
Ask a question you can press star followed by one on just how to think.
Pat I.
I'd like to remove your question you May press Star two.
So you're on mute likely when asking your question.
Our first question for today comes from my reference open Evercore ISI your.
Umer Raffat: Hi, guys. Thanks for taking my question. I noticed a dose level C was dropped in your TL1A trial. I'm assuming that was the highest dose. So, I have a two-part question. One, can you confirm that among the dose level A and B that was kept, you have at least a 500-milligram dose in there? And secondly, I understand that the decision to drop the dose level C was informed by optimizing evolving biomarker data. Could you please elaborate on that as well? Thank you.
Hi, guys. Thanks for taking my question.
I noticed a dose level fee was dropped in your <unk> trial.
Assuming that was the highest dose.
So I have a two part question one can you confirm that among the dose level A&P that was capital you have at least a 500 milligram dose in there and secondly, I understand that the decision to drop the dose level was informed by optimizing involving biomarker data could you. Please elaborate on that as well. Thank you.
Richard Francis: Hi, Umer. Thanks for the call and thanks for the question. Eric, I'll hand that one to you.
Hi.
Thanks for the call.
For the question, Eric I'll hand over to you.
Eric A. Hughes: Thank you tomer. Yes, we amended our study design that we drop the dose this was driven largely in part by our comparative in vitro data as I mentioned in our the potency of the compound as we believe is best in class. We think the selectivity drives a lot of our potential biomarker movement. When you were looking at <unk> levels, which I.
Eric A. Hughes: Thank you, Umer. So, yes, we amended our study design and we dropped the dose. This was driven largely, in part, by our comparative in vitro data. As I mentioned, the potency of the compound is - we believe is best-in-class. We think the selectivity drives a lot of our potential biomarker movement. You know, we were looking at three TL1A levels, which I think are important in dose selection. And we use this in combination with our PK and what we've observed in other development programs when we look at exposures in the program. So, we took advantage of this, and we optimized the study by dropping a dose and, you know, increasing, actually, the size slightly in the other arm.
Eric A. Hughes: Thank you, Umer. So, yes, we amended our study design and we dropped the dose. This was driven largely, in part, by our comparative in vitro data. As I mentioned, the potency of the compound is - we believe is best-in-class. We think the selectivity drives a lot of our potential biomarker movement. You know, we were looking at three TL1A levels, which I think are important in dose selection.
Yes, we amended our study design that we drop the dose this was driven largely in part by our comparative in vitro data as I mentioned in our the potency of the compound as we believe is best in class. We think the selectivity drives a lot of our potential biomarker movement. When you were looking at <unk> levels, which I.
Eric A. Hughes: We think the selectivity drives a lot of our potential biomarker movement. When you were looking at <unk> levels, which I. Think are important and dose selection and we use this in combination with our PK and what we've observed in other development programs and when we look at exposures in the programs. So we took advantage of this so we optimize the study by dropping a dose and <unk>. Increasing actually the size slightly in the other arm. So we're happy with the changes I think that makes the program more efficient and more useful data that will come out of it and I can't comment on dosing or which dose was removed at this time.
Eric A. Hughes: We think the selectivity drives a lot of our potential biomarker movement. You know, we were looking at three TL1A levels, which I think are important in dose selection. And we use this in combination with our PK and what we've observed in other development programs when we look at exposures in the program. So, we took advantage of this, and we optimized the study by dropping a dose and, you know, increasing, actually, the size slightly in the other arm.
Think are important and dose selection and we use this in combination with our PK and what we've observed in other development programs and when we look at exposures in the programs. So we took advantage of this so we optimize the study by dropping a dose and <unk>.
Eric A. Hughes: And we use this in combination with our PK and what we've observed in other development programs when we look at exposures in the program. So, we took advantage of this, and we optimized the study by dropping a dose and, you know, increasing, actually, the size slightly in the other arm.
Increasing actually the size slightly in the other arm. So we're happy with the changes I think that makes the program more efficient and more useful data that will come out of it and I can't comment on dosing or which dose was removed at this time.
Eric A. Hughes: So, we're happy with the changes. I think that makes the program more efficient and more useful data that will come out of it, and I can't comment on dosing or which dose was removed at this time.
Umer Raffat: Thank you.
Operator: Thank you. Our next question comes from Balaji Prasad from specialty pharma equity research. Your line is now open. Please, go ahead.
Balaji V. Prasad: Hi. Good morning. This is Balaji from Barclays. A couple of questions from me. Richard, just want to get your sense if you think that Teva has reached a spot where you are comfortable or actively seeking to expand your pipeline or portfolio either with BD or in-licensing. Secondly, on the guidance, I still see a US$400 million spread so late into the year, which is rather interesting. Is it fair to assume that you are still expecting some large one-offs so late in the year that can still impact to the extent of a few hundred million dollars if approved? Thank you.
Balaji V. Prasad: Hi. Good morning. This is Balaji from Barclays. A couple of questions from me. Richard, just want to get your sense if you think that Teva has reached a spot where you are comfortable or actively seeking to expand your pipeline or portfolio either with BD or in-licensing.
Richard just wanted to get your sense. If you think that <unk> reached a spot where you are comfortable or are actively seeking to expand your pipeline our portfolio, Ed with BD or in licensing.
Balaji V. Prasad: Secondly, on the guidance, I still see a US$400 million spread so late into the year, which is rather interesting. Is it fair to assume that you are still expecting some large one-offs so late in the year that can still impact to the extent of a few hundred million dollars if approved? Thank you.
Secondly, on the guidance I still see a $400 million spread so late into the year, which is rather interesting.
Is it fair to assume that you are still expecting some large one offs.
Late in the year that can still impact the extent of a few hundred million dollars of approach. Thank you.
Richard Francis: Thanks, Roger Thanks for the call and the question I appreciate that. So on the BD. So ask that question, yes, we are actively looking to BD in a license and we started that we have. <unk> been doing that actively I think we.
Richard Francis: Thanks, Balaji. Thanks for the call and the question. Appreciate that. So, on the BD, to answer that question, yes, we are actively looking to do BD and in-license, and we started that and we've been doing that actively. I think we are excited by the products we have in innovation within the market and in our pipeline. That said, as we committed in the pivot to growth, we want to build on that. We think we have capacity to add products, both in our pipeline and also commercially.
So on the BD.
So ask that question, yes, we are actively looking to BD in a license and we started that we have.
<unk> been doing that actively I think we.
Richard Francis: I think we are excited by the products we have in innovation within the market and in our pipeline. That said, as we committed in the pivot to growth, we want to build on that. We think we have capacity to add products, both in our pipeline and also commercially. So, we are actively doing that, but we want to be very selective, make sure it fits to our portfolio, our TA strategy, and so, that does take some time.
Richard Francis: I think we are excited by the products we have in innovation within the market and in our pipeline. That said, as we committed in the pivot to growth, we want to build on that. We think we have capacity to add products, both in our pipeline and also commercially.
Excited by the products, we have an innovation within the market and in our pipeline that said.
As we committed in the pivot to growth and we want to build on that.
We have capacity to add products, both in our pipeline and also commercially. So we are actively dana, but we want to be very selective make sure it fits to our portfolio strategy.
Richard Francis: So, we are actively doing that, but we want to be very selective, make sure it fits to our portfolio, our TA strategy, and so, that does take some time. With regard to the guidance, I think your question was the 15.1 to the 15.5, a bit of a range there, do we expect a one-off to drive that? I'll let Eli answer that. So, over to you Eli.
So that does take some time.
With regards to the guidance I think your question was $50 one to the $15 five.
Or a range that do we expect a one off to drive that.
I'll, let Andy answer that.
So over to Elliot.
Eli Kalif: Yes. Thanks, Balaji, for the call - for the question, sorry. And basically, we are actually keeping the guidance for Austedo so you can actually look on the first three quarters and understand the growth there, year-over-year Q4, just on Austedo. But namely, in terms of the other elements and underlying on the revenue, there is nothing there in specific that are going to be changed versus the current trend, considering this is analogy of Q4 that we have each year. Thanks for the question.
Eli Kalif: Yes. Thanks, Balaji, for the call - for the question, sorry. And basically, we are actually keeping the guidance for Austedo so you can actually look on the first three quarters and understand the growth there, year-over-year Q4, just on Austedo. But namely, in terms of the other elements and underlying on the revenue, there is nothing there in specific that are going to be changed versus the current trend, considering this is analogy of Q4 that we have each year.
For the question.
And basically we are actually keeping the guidance.
Instead of that you can actually look on the first three quarters and understand the growth there.
Year over year, Q4, and just on the schedule.
But namely in terms of the other elements in the underlying on the revenue there is nothing there in specific debt.
Going to be a change versus.
Yes.
Considering the seasonality of Q4 that we have each year.
Richard Francis: Thanks for the question.
Thanks for the question.
Operator: Thank you. Our next question comes from Jason Gerberry of Bank of America. Your line is now open. Please, go ahead.
Our next question comes from Jason <unk> of Bank of America.
Your line is now open. Please go ahead.
Jason Gerberry: Hey, guys. Thank you for taking my questions. I guess, firstly, just on the TL1A partnership, I actually had a follow-up question regarding the US$600 million milestone for starting phase III. Is that contingent just on showing something stat sig as a benefit or do you actually need to generate data that are competitive with the more advanced TL1A programs? Just wondering how much risk there is to kind of capturing that US$600 million milestone and moving forward.
On the <unk> partnership I actually had a follow up question regarding the <unk>.
The $600 million milestone for starting phase III.
Is that contingent on showing something stat, Sig benefit or do you actually need to generate data that are competitive with the more advanced programs. Just wondering how much risk there is to kind of capturing that $600 million milestone and moving forward.
Jason Gerberry: And then, my second question just on your EBITDA guide for the year, I guess to get to the midpoint or the high end of the range, it's a pretty substantial sequential step-up. I get that there's going to be more brand revenue, better mix, better margin in the fourth quarter, but you presumably won't have the generic Revlimid contribution. So, how should we think about opex swings here in fourth quarter, versus sort of the run rate in the three quarters leading into 4Q? Like would we expect a step-down in opex or is there some other factor that can drive this big sequential uptick?
I get that theres going to be more brand revenue better mix better margin in the fourth quarter, but you presumably won't have the generic revlimid contribution.
So how should we think about opex swings here in fourth quarter versus sort of the run rate in the three quarters, leading into <unk> like would we expect a step down in opex or is there. Some other factor that can drive this big sequential uptick.
Richard Francis: OK, Jason. Thanks for the question. I'll start in answering, then I'll let my colleagues contribute. So, on the TL1A, the phase III, there were no conditions around the phase 3. The weather conditions around the phase III the phase III is completing the phase III have a disconnect here. To move into. To complete the phase II and FDA approval to move into the phase III. So. That's what the deal is on this though. Criteria around that. Okay, that's very clear with regard to the EBITDA.
Richard Francis: OK, Jason. Thanks for the question. I'll start in answering, then I'll let my colleagues contribute. So, on the TL1A, the phase III, there were no conditions around the phase III. The phase III is about completing the phase II and have an FDA approval to move into - sorry, have a phase II, complete the phase II and FDA approval to move into the phase III. So, that's what the deal is on. There's no criteria around that. So, I think, hopefully, that's very clear.
I'll, let my colleagues contribute so on the.
The tailwind to phase III.
The weather conditions around the phase III the phase III is completing the phase III have a disconnect here.
To move into.
To complete the phase II and FDA approval to move into the phase III. So.
That's what the deal is on this though.
Criteria around that.
Okay, that's very clear with regard to the EBITDA.
Richard Francis: With regard to the EBITDA and the range, I think it was, and a bit about opex. So, maybe I'll start this, and then Eli can contribute. So, you have seen and Eli did talk about our opex going up, but this is in line with our strategy. This is in line with what we plan to execute.
The range I think it was in a bit about opex.
So maybe I'll start this and then I think.
Contribute so you have seen it and talk about our opex going up but this is in line with our strategy. This is in line with what we plan to execute.
Richard Francis: We're driving Austedo and making sure that brand is supported appropriately. The same for Uzedy, a product we just launched for schizophrenia. And obviously, Eric and his team have started to hit the ground running, particularly on olanzapine and also TL1A and recruiting, you know, faster than we expected. So, obviously, it incurs costs, but I think that's a good thing, particularly if that's part of our pivot to growth strategy.
Eric and his team started to hit the ground running particularly on Olanzapine and also tier one recruiting.
And we expected that obviously incurred costs, but I think thats a good thing, particularly if that's part of our pivot to growth strategy.
Richard Francis: Those are the reasons why the Opex is probably. It has gone up. The reason why it's gone up but we're pleased with them because it's in line with what we want to do. Now obviously going forward just to give a bit of flex to the opex of the R&D of <unk> in partnership with. Sanofi will have a 50%. Of that cost taken by Sanofi, So as we move into next year, and possibly depending where it closes. This year. It will have a contribution from Sanofi. So I think that we've thought about that that allows us to manage our pipeline and to be.
Richard Francis: So, those are the reasons why the opex is probably has gone up. Those are the reasons why it's gone up, but we're pleased with them because it's in line with what we want to do. Now, obviously, going forward, just to give a bit of flavor to the opex on the R&D, obviously, TL1A in partnership with Sanofi will have a 50% of that cost taken by Sanofi. So, as we move into next year and possibly depending on where it closes this year, we'll have a contribution from Sanofi.
It has gone up.
The reason why it's gone up but we're pleased with them because it's in line with what we want to do.
Now obviously going forward just to give a bit of flex to the opex of the R&D of <unk> in partnership with.
Sanofi will have a 50%.
Of that cost taken by Sanofi, So as we move into next year, and possibly depending where it closes. This year. It will have a contribution from Sanofi. So I think that we've thought about that that allows us to manage our pipeline and to be.
Richard Francis: So, I think that we've thought about that, that allows us to manage our pipeline and to be very thoughtful, but also think big about what we want to do with TL1A now we have this collaboration. So, and then the final part I'll say is, as we've commented before, you know, Revlimid was a contributor in Q3. We see that as a significantly less contributor in Q4, a very, very small part of that. And so, you take that into account. But, Eli, maybe you'd like to add a bit more flavor to that as well.
Very thoughtful but also think big about what we wanted to wait till now we have this collaboration so.
And then the final part of assays.
As we've commented before Revlimid was about the future in Q3, we see that as a significantly less contribution in Q4 very very small part of that so you take that into account.
Ali maybe lights out a bit more flavor to that as well.
Eli Kalif: Yeah. So, thanks, Jason. So, overall, the way we need to think about it, we will end up according to the guidance with higher revenue versus the last year. But we will trend the opex at the level of close to 26% of our revenue.
Overall, the way we need to think about it we will end up.
According to the guidance with higher revenue versus last year.
But who would trend the opex and the level of close to 26% of our revenue.
Eli Kalif: And that's the way to think about it. And another point for you to consider, we're still looking for the 53% gross margin for the year-end, which means there is a step-up in Q4, which is mostly related to a further mix that we have in that quarter, and that will drive our ability to sustain the EBITDA guidance, although obviously still increasing in terms of dollars.
In that quarter and that will drive our ability to sustain the EBIT guidance, although it's been a good thing in terms of dollars.
Richard Francis: Thank you, Jason.
Operator: Thank you. Our next question comes from Nathan Rich of Goldman Sachs. The line is now open. Please, go ahead.
Question comes from Nathan Rich of Goldman Sachs. Your line is.
Is now open. Please go ahead.
Nathan Allen Rich: Great Good morning, and thanks for the questions. You mentioned the higher R&D expense in the quarter I think you kind of expect maybe a bit of a step down in the fourth quarter, but I guess going forward, what's the right way to think about R&D expense as a percent of sales just given the investments youre, making in the in the pipeline does that.
Nathan Allen Rich: Great. Good morning and thanks for the questions. You mentioned the higher R&D expense in the quarter. You know, I think you kind of expect maybe a bit of a step-down in the fourth quarter. But I guess going forward, what's the right way to think about R&D expenses as a percent of sales, just given the investments you're kind of making in the pipeline? Does that, move up a bit over time? And then on Uzedy, you mentioned the positive feedback from providers. I was wondering if you could just elaborate a little bit on that and how that's kind of informed your view on the pace of uptake and how we should be thinking about the revenue contribution from this product as we go into next year?
Nathan Allen Rich: Great. Good morning and thanks for the questions. You mentioned the higher R&D expense in the quarter. You know, I think you kind of expect maybe a bit of a step-down in the fourth quarter. But I guess going forward, what's the right way to think about R&D expenses as a percent of sales, just given the investments you're kind of making in the pipeline? Does that, move up a bit over time?
You mentioned the higher R&D expense in the quarter I think you kind of expect maybe a bit of a step down in the fourth quarter, but I guess going forward, what's the right way to think about R&D expense as a percent of sales just given the investments youre, making in the in the pipeline does that.
Nathan Allen Rich: But I guess going forward, what's the right way to think about R&D expenses as a percent of sales, just given the investments you're kind of making in the pipeline? Does that, move up a bit over time? And then on Uzedy, you mentioned the positive feedback from providers. I was wondering if you could just elaborate a little bit on that and how that's kind of informed your view on the pace of uptake and how we should be thinking about the revenue contribution from this product as we go into next year?
No.
Nathan Allen Rich: And then on Uzedy, you mentioned the positive feedback from providers. I was wondering if you could just elaborate a little bit on that and how that's kind of informed your view on the pace of uptake and how we should be thinking about the revenue contribution from this product as we go into next year?
Move up a bit over time and then on news.
Mentioned the positive feedback from providers I was wondering if you could just elaborate a little bit on that and how thats kind of informed your view on the pace of uptake and what.
How we should be thinking about the revenue contribution from this product as we go into next year.
Richard Francis: Thanks for the question as stated. So just. I'm, sorry, but just to sort of cover on the R&D expense. We don't expect a. <unk> stepped out in Q4, because this is part of our strategy and the strategy is to aggressively move of our innovative pipeline through the clinic and as I said, we have Ics ever phase III, we have olanzapine. Full tilt in phase III, and obviously tailwind. As to which we're moving. Very aggressively so I think that's.
Richard Francis: Thanks for the question, Nathan. So, just to - I'm sorry, but just to sort of comment on the R&D expense, no, we don't expect a step-down in Q4 because this is part of our strategy, and the strategy is to aggressively move our innovative pipeline through the clinic. And as I said, we have ICS/SABA entered phase III. We have olanzapine at full tilt in phase III and, obviously, TL1A in phase II, which we're moving very aggressively.
So just.
I'm, sorry, but just to sort of cover on the R&D expense.
We don't expect a.
<unk> stepped out in Q4, because this is part of our strategy and the strategy is to aggressively move of our innovative pipeline through the clinic and as I said, we have Ics ever phase III, we have olanzapine.
Full tilt in phase III, and obviously tailwind.
As to which we're moving.
Very aggressively so I think that's.
Richard Francis: so I think that's. Thats all purpose and that will continue I'll, let Ali talk a bit about where we will be a percentage of sales, but obviously. One thing to always consider which. It may be slightly new with tablets. Sales, we have shown that we've gotten ourselves for the second quarter in a row. We are moving the business back to growth. So obviously that does allow us some flexibility. I want to show you our focus on expenses is maniacal so. That's just something worth understanding fidelity toward it gives a bit more flavor, yes. So overall the way to think about R&D. We are actually looking to trend just a bit above 6% for the year end.
Richard Francis: So, I think that's on purpose and that will continue. I'll let Eli talk a bit about where we will be in percentage of sales, but obviously, one thing to always consider which may be slightly new with Teva is our sales, we have shown that we've grown our sales for the second quarter in a row and we are moving the business back to growth. And so, obviously, that does allow us some flexibility. Although I want to assure you, our focus on expenses is maniacal. So, that's just a link worth understanding. But, Eli, do you want to give a bit more flavor?
Thats all purpose and that will continue I'll, let Ali talk a bit about where we will be a percentage of sales, but obviously.
One thing to always consider which.
It may be slightly new with tablets.
Sales, we have shown that we've gotten ourselves for the second quarter in a row.
We are moving the business back to growth. So obviously that does allow us some flexibility.
I want to show you our focus on expenses is maniacal so.
That's just something worth understanding fidelity toward it gives a bit more flavor, yes. So overall the way to think about R&D. We are actually looking to trend just a bit above 6% for the year end.
Richard Francis: yes. So overall the way to think about R&D. We are actually looking to trend just a bit above 6% for the year end. Which means that Q4 will still have a step up and as I mentioned in my prepared remarks actually. Providing more transparency here between $2 32 to 50 and that will be by itself is very close to it. I would say to add to the. 6% that we see. In the quarter and for the year. Way to think about it going forward. Of course, we will provide our guidance for 'twenty four on the back of Q4 on February but the way to think about it it will be a range between six to six 5% of our revenue going forward. According to our strategy and this is mostly a really.
Richard Francis: Yes. So, overall, the way to think about R&D, we are actually looking to trend just a bit above 6% for the year-end, which means that Q4 will also have a step-up. And as I mentioned in my prepared remarks, we're actually providing kind of a more transparency here between 230 to 250, and that will be, by itself, very close to, I will say, to the 6% that we see in the quarter and for the year. The way to think about it going forward, of course, we will provide our guidance for '24 on the back of Q4 in February, but the way to think about it, it will be a range between 6% to 6.5% of our revenue going forward according to our strategy.
Richard Francis: Yes. So, overall, the way to think about R&D, we are actually looking to trend just a bit above 6% for the year-end, which means that Q4 will also have a step-up. And as I mentioned in my prepared remarks, we're actually providing kind of a more transparency here between 230 to 250, and that will be, by itself, very close to, I will say, to the 6% that we see in the quarter and for the year.
Which means that Q4 will still have a step up and as I mentioned in my prepared remarks actually.
Providing more transparency here between $2 32 to 50 and that will be by itself is very close to it.
I would say to add to the.
6% that we see.
Richard Francis: The way to think about it going forward, of course, we will provide our guidance for '24 on the back of Q4 in February, but the way to think about it, it will be a range between 6% to 6.5% of our revenue going forward according to our strategy.
In the quarter and for the year.
Way to think about it going forward.
Of course, we will provide our guidance for 'twenty four on the back of Q4 on February but the way to think about it it will be a range between six to six 5% of our revenue going forward.
According to our strategy and this is mostly a really.
Richard Francis: And this is mostly related to the mix inside the innovative feed in the R&D.
Weighted to the mix inside the innovative piece and the R&D.
Richard Francis: Thanks, Eli. And then moving on to Uzedy, and we talked a bit, I think the question was around the positivity we have and then for next year. So, I'll hand that to Sven, head of the North America, to give us some flavor for the excitement in the market.
Positivity, we have in the next year, so I'll hand that to <unk>.
<unk>.
North American give some flavor for the excitement in the market.
Sven Dethlefs: Yes. Thank you, Richard. So, we have a very good uptake. Our launch plan is full on track. We are, of course, now working toward market access. In hospital access, listing on hospital formularies, we are right on plan. Medicaid and Medicare, we are also in discussions here. We have secured on par access with Uzedy and Austedo in a couple of states, and we are working toward this goal with all the remaining states, but also with the Medicare plans so that we are quite confident that we will have a very good market access position going into 2024.
Sven Dethlefs: Yes. Thank you, Richard. So, we have a very good uptake. Our launch plan is full on track. We are, of course, now working toward market access. In hospital access, listing on hospital formularies, we are right on plan. Medicaid and Medicare, we are also in discussions
Most are working towards market access in hospital access listing on hospital Formularies, we are right on plan in Medicaid and Medicare. We are also in discussions here we have secured.
Sven Dethlefs: here. We have secured on par access with Uzedy and Austedo in a couple of states, and we are working toward this goal with all the remaining states, but also with the Medicare plans so that we are quite confident that we will have a very good market access position going into 2024.
On part access with the backup to stand out in a couple of states and we are working towards this goal with all the remaining states, but also with the Medicare plans. So that they are quite confident that we will have a very good market access.
Excess position going into 2024.
Sven Dethlefs: What is very encouraging for us is that the product profile that we're hopeful we'll find that. Good reception with physicians actually plays out as planned we've generated so far about 4000 prescriptions. Please keep in mind that we have a large number of free surplus in the market to get patients started so when we move forward in the future. The Isps samples, we received more paid for prescriptions, but as we get through so today.
Sven Dethlefs: What is very encouraging for us is that the product profile that we hope for will find a good reception with physicians actually plays out as planned. We have generated so far about 4,000 prescriptions. Please keep in mind that we have a large number of free samples in the market to get patients started. So, when we move forward and have utilized these samples, we will see more paid-for prescriptions.
Good reception with physicians actually plays out as planned we've generated so far about 4000 prescriptions.
Please keep in mind that we have a large number of free surplus in the market to get patients started so when we move forward in the future. The Isps samples, we received more paid for prescriptions, but as we get through so today.
Sven Dethlefs: But we get to also today the majority of our patients from switches from oral therapies to Uzedy and then from within the category of switches from other LAIs to Uzedy. We have here sources of revenues that come primarily, of course, from the risperidone market, from Perseris and Consta, but also from the other LAIs. So, we believe what we always hope for, aim for, that this becomes a new standard of care in LAI in the LAI segment will actually materialize. And for that reason, we believe that Uzedy will be then a material contributor to our growth in innovative medicines in 2024 and going forward from there.
Sven Dethlefs: But we get to also today the majority of our patients from switches from oral therapies to Uzedy and then from within the category of switches from other LAIs to Uzedy. We have here sources of revenues that come primarily, of course, from the risperidone market, from Perseris and Consta, but also from the other LAIs.
Majority of our patients from switches from oral therapies to your strategy and then.
Within the category of switches from other Nai's too.
To your city.
Sources of revenues that come.
Primarily of course from the Risperidone market focus areas and Comstock, but also from the other.
Sven Dethlefs: So, we believe what we always hope for, aim for, that this becomes a new standard of care in LAI in the LAI segment will actually materialize. And for that reason, we believe that Uzedy will be then a material contributor to our growth in innovative medicines in 2024 and going forward from there.
So we believe what we always hope for aim for if this becomes the new standard of care in AI in DNI segment with actually materialize. It for that reason, we believe that you said you would be a material contributor to our growth in innovative medicines in 2024.
Going forward from there.
Richard Francis: Thank you, Sven. Thank you, Eli. And thank you for the question, Nathan.
Operator: Thank you. Our next question comes from Ash Verma of UBS. Your line is now open. Please, go ahead.
Next question comes from Ash Birla of UBS. Your line is now open. Please go ahead.
Ashwani Verma: Hi. This is Dee asking question on behalf of Ash. Thanks for taking our questions. So, I have two. The first one is on Austedo. Can you give us some color on where the XR is taking share from? So, it's now run rate, it's at around like 10% of total molecule. So, we just want to understand, is it taking shares from regular Austedo, generics, or Ingrezza? The second question [inaudible], can you give us a rough sense for what's the EBITDA margin for the stand-alone business? Also curious, how that margin profile has been trending for the last few years? Thank you.
The first one.
Al.
Thank you some color on where the XR is taking share from so now run rate.
10% of total molecule.
So I just want to understand is it taking share from reservoir that all generic or in Gaza.
Second question.
Okay. Thank.
Can you give us a rough sense for what is the EBITDA margin for the Standalone business also curious how how does that margin profile has been trending for the last few years. Thank you.
Richard Francis: Well thank you. Push out of SG&A, but thanks for asking the question. Ill. And of the aesthetic question too. You can get a bit more detail on that yeah. Thanks for the question. So it's offtake is strong.
Richard Francis: Well, thank you - sorry, I missed your name, but thank you for asking the question. I'll hand over the Austedo question to Sven, who can give a bit more detail on that.
Push out of SG&A, but thanks for asking the question.
Ill.
And of the aesthetic question too.
You can get a bit more detail on that yeah. Thanks for the question. So it's offtake is strong.
Sven Dethlefs: Yeah. Thanks for the question. So, XR uptake is strong. We have a higher share, actually, in the total business than the 10% that you mentioned. So far, we get around about one-third of our new patient starts on Austedo XR and the other two-thirds on the BID. Of course, that's an annualized figure. It's now ramping up that XR becomes much, much more prominent in new patient starts. And the sources of patients in itself for these patient starts are around about half of them are naive patients that start new on therapy for VMAT2 inhibitor and the other half have come either from BID switches, so, from Austedo BID or from Ingrezza or tetrabenazine.
Sven Dethlefs: Yeah. Thanks for the question. So, XR uptake is strong. We have a higher share, actually, in the total business than the 10% that you mentioned. So far, we get around about one-third of our new patient starts on Austedo XR and the other two-thirds on the BID. Of course, that's an annualized figure. It's now ramping up that XR becomes much, much more prominent in new patient starts.
We have a higher share actually in the total business than the 10% that you mentioned so far we get one to about one third of our new patient starts on <unk> and the other two thirds on Vod of course Thats an annualized.
No ramping up that takes all becomes much much more.
Prominence in new patient starts and the sources of patients.
Sven Dethlefs: And the sources of patients in itself for these patient starts are around about half of them are naive patients that start new on therapy for VMAT2 inhibitor and the other half have come either from BID switches, so, from Austedo BID or from Ingrezza or tetrabenazine.
In the telco these patients thoughts are.
Wrote about half of them on their patients.
Not new on therapy for <unk> inhibitor and the other half will come either from.
Switches for the <unk>.
Sven Dethlefs: So, here, what is encouraging for us is that we have a significant number of new prescribers that have never prescribed Austedo before, that now start prescribing Austedo XR because they value the convenience of a once-daily formulation, and I think that's very good for us because that is a market segment that we could not access before in the absence of a once-daily formulation. So, for that reason here, I think we are right on track in making Austedo a continuous growth driver for our innovative business.
The market segments.
Excess before in the absence of a once daily formulation. So for that reason here I think we are right on track and making a steady continuous growth driver for our innovative business.
Richard Francis: Thank you, Sven. And to your second question about Tapi guidance and EBITDA, both past and present and future, we are not giving any level of detail on EBITDA for Tapi at this moment. Thank you.
Guidance for the EBITDA.
Thoughts to present in future, we are not giving any.
That level of detail on EBITDA for <unk> at this moment.
Thank you.
Operator: Thank you. Our next question comes from Glen Santangelo from Jefferies. Your line is now open. Please, go ahead.
Question comes from Glen Santangelo from Jefferies. Your line is now open. Please go ahead.
Glen Joseph Santangelo: Oh, yes, thanks for taking my questions. Just two quick ones from me, obviously with so much focus on the innovative pipeline generic often get overlooked. Richard It seems like the generics business had a great quarter, particularly in North America, the trend seems to be getting a little bit stronger I was wondering if you could just sort of comment on the competitive and pricing dynamics that that may be driving that trend and then secondly, as it relates to the Alphatec partnership the company made an additional investment there.
Glen Joseph Santangelo: Yeah. Thanks for taking my questions. Just two quick ones from me. Obviously, with so much focus on the innovative pipeline, generics often get overlooked. I mean, you know, Richard, it seems like the generics business had a great quarter, particularly in North America. The trend seems to be getting a little bit stronger. I was wondering if you could just sort of comment on the competitive and pricing dynamics that may be driving that trend.
Richard It seems like the generics business had a great quarter, particularly in North America, the trend seems to be getting a little bit stronger I was wondering if you could just sort of comment on the competitive and pricing dynamics that that may be driving that trend and then secondly, as it relates to the Alphatec partnership the company made an additional investment there.
Glen Joseph Santangelo: And then secondly, as it relates to the Alvotech partnership, the company made an additional investment there, you know, in the wake of a number of CRLs, right, more recently on Stelara. Could you give us an update on that relationship and the biosimilar pipeline, as it relates to that Alvotech partnership? Thanks.
The number of Crlf right more recently on <unk> could you give us an update on that relationship and the Biosimilar pipeline as it relates to that that.
That alphatec partnership.
Richard Francis: Thanks, Glen. Thanks for the question. So, we are pleased about the performance of our generics business. I think this is a journey in our strategy to make sure our generics business is a sustainable powerhouse.
So we are pleased about the performance of our generics business I think this is a journey and our strategy to make sure generics businesses is sustainable.
Richard Francis: And within North America, you've obviously seen a strong quarter there. I think Eli did highlight that, you know, a big contributor to that was Revlimid. What I would say about your sort of more general market conditions around more favorability, and I've been consistent on this, I think to be - the market conditions will change, based on supply, demand, and competition, and that will be constant. And so, as more people come into a market, the prices will go down because the competition will drive that.
Contributed to that with Revlimid.
What I would say.
<unk> is sort of more general market conditions around will favorability.
I've been consistent on this I think to be.
The market conditions will change based on supply demand and competition and that will be constant and so as more people come into a market.
The prices will go down because the competition will drive that I don't see those dynamics changing there'll be quarters, where the pricing pressures lessen there'll be quarters, where the pricing pressure is more I think for our strategy to make sure we could be in control of that we focused our R&D engine onto her accused of making sure we deliver our generics and our complex generics.
The prices will go down because the competition will drive that
Richard Francis: I don't see those dynamics changing. There will be quarters where the pricing pressure is less and there'll be quarters when the pricing pressure is more. I think, for our strategy, to make sure we can be in control of that, we focused our R&D engine under Eric Hughes on making sure we deliver our generics and our complex generics on time and first to the market more than we have done in the past. And that's where we'll drive value creation and will insure ourselves against this volatility within the market.
All time first and first to the market more than we have done in the past and Thats why we will dry by the accretion will ensure ourselves against this volatility within the market. So I think thats, how we think about rapid going forward and how we think about making sure we stay competitive and have a sustainable business.
All time first and first to the market more than we have done in the past and Thats why we will dry by the accretion will ensure ourselves against this volatility within the market.
Richard Francis: So, I think that's how we think about the market going forward and how we think about making sure we stay competitive and have a sustainable business. With regard to Alvotech and the partnership, the relationship is actually very good. I mean, one of the things we did when we invested again into this partnership is - and I've said this before as well, Alvotech is very good when it comes to developing biosimilar, their R&D capability. I think we will have the best product on the market if we launch Humira, both from a device point of view, from a product profile interchangeability, they're very good at that.
With regard to Alphatec in the partnership.
The relationship is actually very good I mean, one of the things we did when we invested again. This partnership is and I've said this before as well I will take is very good when it comes to developing bus.
D capability I think we will have the best product in the market. If we launch humira both from a device point of view from a product profile. Its changeability theyre very good at that what we're doing is working even more closely with them to ensure that from a manufacturing capability.
D capability I think we will have the best product in the market. If we launch humira both from a device point of view from a product profile. Its changeability theyre very good at that
Richard Francis: What we're doing is working even more closely with them to ensure that from a manufacturing capability, we can help them not only get through the FDA inspection but also be able to deliver the volumes that we see will be necessary. And that's something which we're very capable at because we have 53 sites, we have a roughly 30 FDA inspections a year. So, we do know what we're doing. But I think what - maybe to conclude, the relationship is very strong.
We can help them get through the FDA inspection, but also be able to be.
To deliver the bulk of is that we see will be necessary and that's something which we're very capable at because we have 53 sites. We have a roughly 30 FDA inspections of year. So we do know what we do but.
But I think what maybe to conclude the relationship is very strong.
Richard Francis: Our pipeline, we've expanded with them because we see their capability. We continue to build out our pipeline through partnerships. And so, you'll see some announcements on that hopefully in the future because we do believe our strategy is to have a broad portfolio, predominantly through partnerships, and that allows us to go to the market with a portfolio play and also to insure ourselves against the peaks and troughs that are associated with launching biosimilars one year and then maybe not having them the next. So, hopefully that answers your question, Glen. I appreciate the call.
Through partnerships and so youll see some announcements on that hopefully in the future because we do believe our strategy is to have a broad portfolio predominantly through partnerships and that allows us to go to market with a portfolio play and also to ensure ourselves against the peaks and troughs associated with launching Biosimilars one year, maybe go after them.
The next so hopefully that answers your question Glenn and I appreciate the call.
Glen Joseph Santangelo: Yep. Thank you.
Operator: Thank you. Our next question comes from David Amsellem of Piper Sandler. Your line is now open. Please, go ahead.
Thank you. Our next question comes from David <unk> of Piper Sandler.
Your line is now open. Please go ahead.
David Amsellem: Hey. Thanks. So, a couple of high-level questions just on overall strategy. So, you know, with the upfront payment in hand from Sanofi, you have a little more wiggle room here, I should say. And with that in mind, are you focused on assets in neuropsychiatry, where you can leverage your commercial infrastructure that you have in place? Is that the top priority there? And then secondly, as it relates to biosims, just coming back to Viatris, getting out of that business, how do you think about your role in biosims going forward? I know what you're saying in your comments, but is that something you could be opportunistic about going forward, in terms of monetizing that business? Thank you.
David Amsellem: Hey. Thanks. So, a couple of high-level questions just on overall strategy. So, you know, with the upfront payment in hand from Sanofi, you have a little more wiggle room here, I should say. And with that in mind, are you focused on assets in neuropsychiatry, where you can leverage your commercial infrastructure that you have in place? Is that the top priority there? And
David Amsellem: Hey. Thanks. So, a couple of high-level questions just on overall strategy. So, you know, with the upfront payment in hand from Sanofi, you have a little more wiggle room here, I should say. And with that in mind, are you focused on assets in neuropsychiatry, where you can leverage your commercial infrastructure that you have in place? Is that the top priority there?
With the upfront payment.
From Sanofi.
You have a little more.
Room here Wiggle room here I should say.
And with that in mind are you focused on assets in neuropsychiatry, where you can leverage your commercial infrastructure that you have in place is that the top priority there.
David Amsellem: And then secondly, as it relates to biosims, just coming back to Viatris, getting out of that business, how do you think about your role in biosims going forward? I know what you're saying in your comments, but is that something you could be opportunistic about going forward, in terms of monetizing that business? Thank you.
David Amsellem: then secondly, as it relates to biosims, just coming back to Viatris, getting out of that business, how do you think about your role in biosims going forward? I know what you're saying in your comments, but is that something you could be opportunistic about going forward, in terms of monetizing that business? Thank you.
And then secondly.
As it relates to Biosimilars.
Just coming back to <unk> getting out of that business. How do you think about your role in Biosimilars going forward I know, what youre, saying in your comments, but.
Is that something you could be opportunistic about.
Going forward in terms of monetizing that business. Thank you.
Richard Francis: Thanks for the question, David. So, starting with the - I think, basically, you're saying because our financial situation improves with the TL1A deal and the US$500 million upfront, you know, how do we think about BD? So, as I said, we are thinking about BD. We're active. If you're looking, we've hired Angus Grant, a seasoned professional, dare I say, a legend in the industry who's worked in innovative medicines all his life.
So starting with the.
Maybe I should say because.
Our financial situation improves with the tier one deal in the $500 million upfront how.
How do we think about PD. So as I said, we're all thinking about the PD. We're active we're looking we've hired Argus gone a a seasoned professional dare I say legend in the industry.
Who has worked at innovative medicines all his life.
Richard Francis: And so, we really have stepped up that and our capability around that and our focus on that. Now, yes, we are targeting CNS immunology. And within CNS, obviously, psychiatry and neurology because we see the synergy play there. We're building a capability. In fact, in psychiatry, I think we're seen as one of the leaders in psychiatry now. So, I think it makes sense to look there. That said, you know, as opportunities come along, which may be in a broader CNS, we'll look at them. But right now, we're ensuring we stay focused to make sure we allocate our capital in a way that will be synergistic to our P&L and maximize our opex.
Immunology within CNS, obviously, psychiatry and neurology, because we see the synergy play that we're building a capability in fact in psychiatry I think we've seen as one of the leaders in psychology now so.
It makes sense to look at.
That said as opportunities come along which might be in a broader CNS will look at them right now.
Ensuring we stay focused to make sure we allocate our capital in a way that will be synergistic to our.
P&L and maximize of Opex with.
Richard Francis: With regards to the Biosimilar question. I think our strategy is really clear I think biosimilars is a massive opportunity to generate revenue. That in Europe, I believe that's going to happen in the United States it'll be a bit bumpy in the United States as we've seen in the past, but we've also seen with truck sema.
Richard Francis: With regard to the biosims question, you know, I think our strategy is really clear. I think biosimilars is a massive opportunity to generate revenue. I've seen that in Europe. I believe that's going to happen in the United States. It'll be a bit bumpy in the United States, as we've seen in the past. But we've also seen with Truxima, our biosimilar of rituximab, it's a great revenue generator.
I think our strategy is really clear I think biosimilars is a massive opportunity to generate revenue.
That in Europe, I believe that's going to happen in the United States it'll be a bit bumpy in the United States as we've seen in the past, but we've also seen with truck sema.
Richard Francis: as we've seen in the past, but we've also seen with truck sema. Of Rituximab. A great revenue generator. So the way we address maybe some of that uncertainty is to ensure that we don't allocate huge amount of capital to do that through partnerships and we built a broad portfolio. So with some assets come to market in a timely manner. Some assets over achieve and other assets under achieved peak sales could look like with balancing that out because we have a portfolio approach, but we feel very. Clear on our strategy and committed to our strategy. We think it's the right strategy for a company like Teva.
Richard Francis: It'll be a bit bumpy in the United States, as we've seen in the past. But we've also seen with Truxima, our biosimilar of rituximab, it's a great revenue generator. So, the way we address maybe some of that uncertainty is to ensure that we don't allocate a huge amount of capital to it by doing that through partnerships and we build a broad portfolio, so when some assets come to the market in a timely manner or some assets overachieve and other assets underachieve on what their peak sales could look like, we're balancing that out because we have a portfolio approach. But we feel very clear on our strategy and committed to our strategy.
Richard Francis: It'll be a bit bumpy in the United States, as we've seen in the past. But we've also seen with Truxima, our biosimilar of rituximab, it's a great revenue generator.
Of Rituximab.
A great revenue generator.
Richard Francis: So, the way we address maybe some of that uncertainty is to ensure that we don't allocate a huge amount of capital to it by doing that through partnerships and we build a broad portfolio, so when some assets come to the market in a timely manner or some assets overachieve and other assets underachieve on what their peak sales could look like, we're balancing that out because we have a portfolio approach. But we feel very clear on our strategy and committed to our strategy. We think it's the right strategy for a company like Teva. Thanks for your question, David.
So the way we address maybe some of that uncertainty is to ensure that we don't allocate huge amount of capital to do that through partnerships and we built a broad portfolio. So with some assets come to market in a timely manner.
Some assets over achieve and other assets under achieved peak sales could look like with balancing that out because we have a portfolio approach, but we feel very.
Clear on our strategy and committed to our strategy. We think it's the right strategy for a company like Teva.
Richard Francis: We think it's the right strategy for a company like Teva.
Thanks for your question David.
Operator: Thank you. Our final question for today comes from Chris Schott of J.P. Morgan. Your line is now open. Please go ahead.
Our final question for today comes from Chris Schott of Jpmorgan.
Your line is now open. Please go ahead.
Chris Schott: Hey. This is Carina on for Chris. Thank you so much for taking our questions. So, first, on gross margins, I know you're not given guidance for next year, but as we think about margin trajectory from here and the trends we saw in Q3 and what we're going to see in Q4, is that kind of the correct starting point as we think about gross margin next year or are there any other pushes and pulls we should keep in mind there? And I think second question is just on Austedo.
And I think the second question is just a little still seems like the product has had a very strong quarter, just latest thinking around kind of investing behind that product and support for the asset. How are you thinking about balancing costs versus kind of maximizing the revenue opportunity has that thinking evolved at all in any implications as we think about SG&A spend next year. Thank you so much.
And I think the second question is just a little still
Chris Schott: It seems like the product has had a very strong quarter. Just latest thinking around kind of investing behind that product and support for the asset, how are you thinking about balancing costs versus kind of maximizing the revenue opportunity? Has that thinking evolved at all and any implications as we think about SG&A spend next year? Thank you so much.
Richard Francis: Thank you Karina. I'll take. Both of those and then also allow my colleague Sven Alita. Ali to contribute so when we think about margin when I think about margin going forward, it's aligned to our strategy. So when you think about our pivot to growth strategy. It was to make the company get back to growth that drove it in areas, where it will drive profitability at the top or the bottom line now obviously I think Ali has just highlighted and I highlighted in my comments that we improved gross margin by 50 basis.
Richard Francis: OK, thank you, Carina. I'll take a go at both of those and then also allow my colleagues, Sven and Eli, to contribute. So, when I think about margin going forward, it's aligned to our strategy. So, when you think about our pivot to growth strategy, it was to make the company get back to growth, but growth in areas where it will drive profitability on the top and the bottom line.
I'll take.
Both of those and then also allow my colleague Sven Alita.
Ali to contribute so when we think about margin when I think about margin going forward, it's aligned to our strategy. So when you think about our pivot to growth strategy. It was to make the company get back to growth that drove it in areas, where it will drive profitability at the top or the bottom line now obviously I think Ali has just highlighted and I highlighted in my comments that we improved gross margin by 50 basis.
Richard Francis: Now, obviously, I think Eli has just highlighted and I highlighted in my comments that we improved gross margin by 50 basis points. The way we did that, primarily is our portfolio mix. So, as we drive Austedo, as we drive Ajovy, as we drive Uzedy, as we bring olanzapine into the market, ICS/SABA into the market, those products have a very different gross margin profile than our generics business. And so, that, by definition, will raise our gross margin. So that's sort of the big picture on it. No. I think it will flag if you will too early yes. So just to know we are still.
Richard Francis: Now, obviously, I think Eli has just highlighted and I highlighted in my comments that we improved gross margin by 50 basis points. The way we did that, primarily is our portfolio mix. So, as we drive Austedo, as we drive Ajovy, as we drive Uzedy, as we bring olanzapine into the market, ICS/SABA into the market, those products have a very different gross margin profile than our generics business. And so, that, by definition, will raise our gross margin. So, that's sort of the big picture on it. I'll let Eli give me a bit more flavor if you want to, Eli.
<unk>.
When we did that primarily as a portfolio mix. So as we drive instead of as you drive the Cherokee as you drive your study as we bring allowed to speak to the market Ics up into the market those products have a very different gross margin profile than our generics business. So that by definition will raise our gross margin. So that's sort of the big picture on it.
When we did that primarily as a portfolio mix. So as we drive instead of as you drive the Cherokee as you drive your study as we bring allowed to speak to the market Ics up into the market those products have a very different gross margin profile than our generics business. So that by definition will raise our gross margin.
So that's sort of the big picture on it.
No.
I think it will flag if you will too early yes. So just to know we are still.
Eli Kalif: Yeah. So, just, you know, we are still actually aligned with our long-term financial target by 2027 to reach the 30% on OP, which means if you look on our trajectory in opex and as we are very, very cautious on even that we are actually dollar spend higher, but you're trending it always versus revenue this year and last year, we believe that between 26% to 27% opex going forward, which means that those gross margin of 65% to 67% on the long term should serve our goals.
Fully aligned with our long term financial targets by 2027th to reach the 30% and op.
Which means if you look on our trajectory in <unk> than we are.
Very very cautions on even that were actually built our spend higher but they are trending.
Always versus revenue.
This year than last year, and we believe that between 26% to 27% and.
Opex going forward, which means that those gross margin of 55% to 67% on a long term should serve our goals.
Richard Francis: And then moving on to instead of. <unk>. We have a very important asset. And because of that we ensure that that is funded. Great way and obviously, we have a big cost base at Teva and so for US it's about prioritization and instead of US what are the what are the top priorities. We have in this company and so when it comes to getting resources.
Richard Francis: And then moving on to Austedo, for Austedo we think we have a very important asset here. And because of that, we ensure that that is funded in the appropriate way. And obviously, we have a big cost base at Teva. And so, for us, it's about prioritization, and Austedo is one of the top priorities we have in this company. And so, when it comes to getting resources, obviously, there's a process to do that. It's not quite an open checkbook for Sven and his team, but it's very much, this is an asset we want to maximize.
<unk>.
We have a very important asset.
And because of that we ensure that that is funded.
Great way and obviously, we have a big cost base at Teva and so for US it's about prioritization and instead of US what are the what are the top priorities. We have in this company and so when it comes to getting resources.
Richard Francis: and so when it comes to getting resources. Obviously, there's a process to do that it's still quite an open checkbook for spend and his team, but it's very much. This is an asset we want to maximize let's understand what that takes and then obviously manage that through other aspects of the business cost structure to make sure we can offset that as much as we can to once again. They vary on top of our spend as our revenue grows we want to make sure our profitability goes with it but do you have anything else to add to that yes. And the budgets that we have is of course that we can make synergistic investment between <unk> and <unk> said to you because some of the prescribers.
Richard Francis: And so, when it comes to getting resources, obviously, there's a process to do that. It's not quite an open checkbook for Sven and his team, but it's very much, this is an asset we want to maximize. Let's understand what that takes and then obviously manage that through other aspects of the business cost structure, to make sure we can offset that as much as we can to once again, stay very on top of our spend. As our revenue grows, we want to make sure our profitability grows with it. But, Sven, do you have anything else to add to that?
Richard Francis: And so, when it comes to getting resources, obviously, there's a process to do that. It's not quite an open checkbook for Sven and his team, but it's very much, this is an asset we want to maximize.
Obviously, there's a process to do that it's still quite an open checkbook for spend and his team, but it's very much. This is an asset we want to maximize let's understand what that takes and then obviously manage that through other aspects of the business cost structure to make sure we can offset that as much as we can to once again.
Richard Francis: Let's understand what that takes and then obviously manage that through other aspects of the business cost structure, to make sure we can offset that as much as we can to once again, stay very on top of our spend. As our revenue grows, we want to make sure our profitability grows with it. But, Sven, do you have anything else to add to that?
They vary on top of our spend as our revenue grows we want to make sure our profitability goes with it but do you have anything else to add to that yes.
Sven Dethlefs: yes. And the budgets that we have is of course that we can make synergistic investment between <unk> and <unk> said to you because some of the prescribers. We target. Prescribed both of the brands, so we add leverage. It can create some scale effects. <unk> stepped up our sales force we have increased our long term care team, we've made investments in specialty pharmacy programs to increase our fill rates and we're also working on adherence and I believe.
Sven Dethlefs: Yes. I think one area an advantage that we have is, of course, that we can make synergistic investment between Austedo and Uzedy, because some of the prescribers that we target prescribed both of the brands. So, we have leverage and we can create some scale effects. We have this year stepped up our sales force. We have increased our long-term care team. We have made investments in specialty pharmacy programs to increase our fill rates. And we are also working on adherence.
And the budgets that we have is of course that we can make synergistic investment between <unk> and <unk> said to you because some of the prescribers.
We target.
Prescribed both of the brands, so we add leverage.
It can create some scale effects.
<unk> stepped up our sales force we have increased our long term care team, we've made investments in specialty pharmacy programs to increase our fill rates and we're also working on adherence and I believe.
Sven Dethlefs: We have increased our long-term care team. We have made investments in specialty pharmacy programs to increase our fill rates. And we are also working on adherence. And I believe the fact that the prescriber base increases as more and more physicians start prescribing VMAT2 inhibitors, it naturally leads you to an opportunity to invest more behind sales and patient activation. And that's what we also plan to do for 2024. But as Richard said, of course, we are quite disciplined in analyzing where we want to invest our dollars.
Sven Dethlefs: We have increased our long-term care team. We have made investments in specialty pharmacy programs to increase our fill rates. And we are also working on adherence.
Sven Dethlefs: And I believe the fact that the prescriber base increases as more and more physicians start prescribing VMAT2 inhibitors, it naturally leads you to an opportunity to invest more behind sales and patient activation. And that's what we also plan to do for 2024. But as Richard said, of course, we are quite disciplined in analyzing where we want to invest our dollars.
The fact that prescriber base increases as more and more physicians prescribing <unk> mature inhibitors.
Naturally leads you to the opportunity to invest more behind.
Sales and patient activation and Thats, what we also tended to move towards 2024, but as Richard said of course, we are quite disciplined.
And analyzing where we want to invest our dollars.
Richard Francis: Thank you, Sven. And I'd like to thank everybody for taking the time to listen to our call and to answer the questions. We do appreciate the interest in Teva, and I wish everybody a good day or good evening. Thank you.
Listen to our call in to ask questions. We do appreciate the interest in server.
And I wish everybody.
Good day good evening. Thank you.
Operator: Thank you for joining today's call, you may now disconnect your lines.
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