Teva Pharmaceutical Industries Limited

Hello and welcome to the Q3 2023 Teva Pharmaceutical Industries Earnings Conference Call. My name is Alex and I'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 it over to your host, Ran Mir, SVP of Investor Relations. Please go ahead.

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 sevafarm.com. Please review our forward-looking statements on slide number two. 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, Tevas CEO, will provide an overview of Tevas Q3 results and business performance, recent events, and our priorities going forward. Then, Dr. Eric Hughes, our head of R&D and chief medical officer, will discuss progress on our innovative pipeline. Our CFO, Eddie Khalif, will follow up by reviewing the financial results in more detail, including our 2023 financial outlook. Joining Richard, Eric, and Elion on the call today is Ben Gitlitz, 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?

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. 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 running 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 longstanding partners to donate products and provide other humanitarian aid. 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 five, 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, Estedo, Jovi, and our generics business. Revenues were up 7% in US and in local currency. Our gross margin continues to improve. We saw an increase by 50 basis points versus Q3 2022. We're pleased to announce an exciting partnership with Sanofi and Q3, a deal to really maximize our TL1A asset. Because of these results, I'm pleased to announce we're going to increase our outlook of revenue to 15.1 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. Deliver on our growth engines, step up innovation, sustain a generics powerhouse, and focus our business. So I'm just going to touch on some of the progress we've made in Q3. As I've just mentioned, Estedo 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. You said he was launched earlier in the year. I'll give you an update on that. And we're pleased to announce with our partner, Alvatech, that we're doing an FDA inspection in early Q1 in 2024, It raises the opportunity that we might be able to launch Humira next year. With regard to innovation, I'm joined on this call by Eric Hughes who will go into more detail, but a couple of highlights are obviously around olanzapine, a long-acting treatment for schizophrenia in 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. To have a generic powerhouse, we make good progress. As you'll 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 standalone business unit for TAPI. I'm 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 of the exciting collaboration with Sanofi. I'm pleased with this collaboration because it really strengthens our pivot to growth strategy. 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. 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. Esteto continued its impressive growth, up 30%, while Adobe continued to grow well at 22%. Pleased to show that we saw growth across all of our regions with particularly strong performance in the US and international markets. Now, to double-click and dive a bit deeper, I'd like to move on to Estedo. Now, Estedo, once again, we confirmed they were committed to the $1.2 billion target for 2023. Revenue was up to $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 $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. And 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 Estedo, so we have work to do there in the ability to improve patients' lives. Now, moving on to the next slide is Jovi. We're on track to reach or even exceed the $400 million for 2023, with good growth in Q3 and revenues of $114 million. As I said, growth was 22%. What I like about Adobe 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 commercial capabilities. Now, moving on to the next slide, the newest member of our innovative family is UCEDD, a long-acting treatment for risperidone launched in May of this year. Now, we're pleased with the launch, and as you can see, UCEDD 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. I think the physicians find the fact that Uceti 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. It's a $4 billion market, and we think Yosedi will have a real part to play in that market. Now, as I've said before, 2023 is a set-up year for 2024. We need to make sure we get access, formal inclusions in our hospitals, and we're making very good progress on that. So, look forward to updating on Yosedi as we near the end of the year. Now, moving away from our innovative portfolio to our generics business. And as I said earlier, I'm pleased to show that we've grown our generics business across all of our regions, U.S. included. And as you can see, strong growth in the U.S. of 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 3 trial, and we look to be announcing, or 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 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 three clinical trials in Q3, we've started to accrue patients already. And this is a significant opportunity. As I mentioned on previous calls, based on the guidelines in the US, there are 10 million patients who should be on an ICS-AVA combination. And so if you just take 30% of these, the market is still significant at 2.5 billion. So a real opportunity to continue to drive growth for Teva in our innovative business. And then finally, on anti-TO1, I have spoken a bit about it, and 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 as around $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. At 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. We were 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 use.

Thank you, Richard. Can I have the next slide? So, as Richard mentioned, we're excited by the improved sales of Osteto, which is a testament to Osteto's safety and efficacy. To build upon what we've already achieved with Esteto, we want to make sure that the flexibility and the convenience of Esteto 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. 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 Osteto, 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 pit roll 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. Go to the next slide. As Richard mentioned, we're also excited to see the improvement, improved sales of adjovi. Adjovi is a a program that we have for migraine, and we can recapitulate our Phase 3 studies and its effect on the monthly migraine days that we improve. So in this study called UNITE, there's a prospective study, but the uniqueness of this study was that we looked at patients with migraine who also had depressive symptoms. And this is important because depression is a comorbidity with migraine that leads to 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 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. So very excited to see this. I think this is a great benefit to patients. Go to the next slide. Now, we're also excited to present more data on Uzeti from our pivotal studies in this sub-analysis. 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? Well, there is the thought that after many years, 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 Luzetti. So greater than 20 years is a very good population to have shown treatment effective. 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 LEIs, this is a continuing theory that LEIs are an effective way of starting treatment. Thank you. 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 III 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. This study is enrolled very quickly, and I'll go over, you know, timelines 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 the desire of investigators to use an injectable olanzapine. Go 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. 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. So more treatments are important in this disease area. We believe we have the best in class potential for T01As. We have a potent compound with great selectivity. We've shown good safety in our asthma study. And we've shown low anti-drug antibodies to date. The collaboration with Sanofi is going to capitalize on potential of this target. This target has the potential to go across many different disease indications. It's a pleiotropic cytokine that affects many different pathways, so the possibilities are large for this group. 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 G1A, we're moving forward. 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 LEI and its acceleration. 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-IL-15 POC study for celiac disease, and we will have our PK from our SAD and MAD studies coming out in the second half of 2024. We are well on our path to have our first patient dosed in our anti-PE1 IL-2 program. in the first half of 2024 when we submit our IMD. And as Richard mentioned, ICS SAVA has now launched into our phase three program and we're looking for results in the 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 gonna pass it off to Eli. 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 2023 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. This growth was mainly driven by higher revenue from generic products, Ostedo and Adobe, partially offset by lower revenue from Bendecca and Triandas. As Richard mentioned, revenues in our generic business in North America increased by 15% in Q3 2023, mainly due to revenues from generics revenues, partially offset by increased competition to other generics products. Revenues in our Europe segment were flat in local currency terms. We continue to see strong growth in Ajovi and a solid growth in our generics business in the third quarter. This was, however, largely offset by low 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 high revenue from our generic products, largely coming from price increases as measured 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. GAAP operating income was $365 million in the third quarter of 2023 compared to an operating income of $419 million in the third quarter of 2022. The lower operating income in the third quarter of 2023 was mainly due to higher legal settlement 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, as Richard and Eric mentioned earlier. in line with our Pivot to Growth strategy. In addition, last year and 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. We also saw an increase in our S&M expenses compared to the third quarter last year, mainly due to promotional activities related to OSTEDO and EUSERI, as well as exchange rate fluctuations in our Europe segment. with a gap income of $80 million compared to the net income of $56 million in Q3 2022, and a gap earning per share of $0.07 compared to gap earning per share of $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. Such integration plans have been adopted, among others, in an effort of addressing the global adoption of OECD pillar to 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 movement during the third quarter of 2023 net of hedging effects negatively impacted our revenues and gap 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 the stronger US dollars against currencies of certain international markets in which we operate partially offset by the benefits from Euro appreciation. Approximately 46% of our revenue in Q3 2013 came from sales denominated in non-US dollar currency. Turning to slide 26. You can see that the total NAND gap adjustment in the third quarter of 2023 were approximately $598 million compared to $602 million in Q3 2022. Notable gap adjustments this quarter include legal settlement, loss contingencies of $314 million, mainly related to estimated provisions recorded in connection with certain litigation cases in U.S., Additional notable adjustments included amortization of purchased intangible assets of 145 million, the majority of which is included in cost of sale. Now moving to slide 27 for review of our NANGAP performance. As I mentioned, our third quarter revenue were totaled approximately 3.9 billion, represented 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 a favorable mix of products including higher revenue from USTEDA in our North America segment, partially offset by higher costs due to inflationary and other macroeconomic pressures. 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, 2033, compared to the second quarter of 2023. This sequential improvement in gross margin was driven by continuous shifts towards a more normalized portfolio mix, mainly driven by strong growth in Osteto, 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 2053 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. We ended the third quarter with a NANGAP earning per share of $0.60 compared to $0.59 in Q3 2022, mainly due to a higher NANGAP operating income, partially offset by higher financial expenses in Q3 2023. Now, let's take a look at our spend base on slide 28. As you can see, our quarterly spend 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 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. As we move forward, we expect our operating expenses to be approximately from $1 billion to $1.5 billion in the fourth quarter, including a quarterly run rate of R&D expenses to be in the range of $230 to $250 million as we continue to progress our pipeline, including the late-stage and innovative assets. 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 0.9 billion of free cash flow versus 1.1 billion during the same period last year, a decrease of 200 million. 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 $1.7 to $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 Estedo. 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, tabled to us under the exclusive collaboration with Sanofi for our anti-TL1A, which we announced in October. Turning to slide 30. Our net debt at the end of Q3 2023 was $17.7 billion, compared to $18.4 billion at the end of 2022. Our gross debt was $20 billion compared to $21.2 billion at the end of 2022. The decrease in our gross debt was mainly due to $1.6 billion dinner notes repaid at maturity and $54 million of exchange rate fluctuations, partially offset by $500 million outstanding under the revolving credit facility as of September 30th, 2023. 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. In September 2023, we repaid $200 million, and as of today, $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 movement as well as big 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 towards our long-term financial target of being two times net debt to EBITDA by end of 2027. Turning to slide 31, which presents our upcoming debt maturities. As I mentioned, we have already repaid $1 billion of our 2.8% standard note of maturity in July 2023. So there are currently no additional maturity payments due in 2023. Following our successful refinancing of approximately $2.5 billion of our debt through a sustainability-linked senior 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. We believe we are well positioned to continue to serve our debt and meet these upcoming maturities over the next couple of years with our ongoing cash flow generation. Now, turning to our 2023 Nangap 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 continuous strong momentum in our key growth engines, especially OSTEDO, continued growth in Najobi, as well as solid performance in our core generic business globally. In addition, we are seeing relatively high revenue from Copaxone compared to our initial expectation, which we now expected to be approximately 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 100 million. We are now expected our revenue to be between 15.1 billion to $15.5 billion for the full year of 2023. We also continue to expect sequential improvement in our margins in the fourth quarter. As previously communicated, we are driving and continuing the shift in our portfolio mix, mainly driven by strong growth in OSTEDO, 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 expected 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 tabled to us under the exclusive collaboration with Sanofi for our anti-TL1A, which we announced in October. With that, This concludes my review of the results for the third quarter of 2023, and now I will hand it back to Richard for a summary.

Thank you, Eli, and thank you, Eric. So, in summary, strong Q3 performance driven by Stedo, the launch of UCEDD and HOV, and good performance across our generics business in all three regions. With that, as you heard from Eli, we're increasing our guidance for revenues this year. And I'm pleased to show that the Pivot to Growth strategy is starting to get traction, as I've highlighted with Estedo, the collaboration with TIL 1A, with the capability build that Eric and his team have done that's allowed us to accelerate a land screen, a long-acting product in Phase 3 studies, as well as with the TEVA API, the recruitment of our CEO. With that, I'll hand it over to people to ask questions.

Thank you. As a reminder, if you'd like to ask a question, you can press star followed by 1 on your telephone keypad. If you'd like to remove your question, you may press star followed by 2. Please ensure you're unmuted locally when asking your question. Our first question for today comes from Uma Rafat of Evercore ISI. Your line is now open. Please go ahead.

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, Uma. Thanks for the call, and thanks for the question. Eric, I'll hand that one to you.

Thank you, Homer. 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 free T01A levels, which I think are important in dose selection. And we use this in combination with RPK and what we've observed in other development programs when we look at exposures in the programs. So we took advantage of this and we optimized the study by dropping a dose and 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.

Thank you. Thank you. Our next question comes from Balaji Prasad from Specialty Pharma Equity Research. Your line is now open. Please go ahead.

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 $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.

Thanks for the call and the question. I appreciate that. So on the BD, to answer that question, yes, we are actively looking to do BD and in-license. We started that. 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 we are actively doing that, but we want to be very selective. make sure it fits to our portfolio, our TA strategy. So that does take some time. With regard to the guidance, I think the 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 Ellie answer that. So over to you, Ellie.

Yes, thanks Balaji for the call, for the question, sorry. And basically, you know, we are actually keeping the guidance for status so you can actually look on the first three quarters and understand the growth there. year-over-year Q4 just on the schedule. But namely, in terms of the other elements and the other lines on the revenue, there is nothing there in specific that's going to be changed versus considering the seasonality of Q4 that we have each year.

Thanks for the question.

Thank you. Our next question comes from Jason at Gerbery of Bank of America. The line is now open. Please go ahead.

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 $600 million milestone for starting Phase 3. Is that contingent just on showing something stat-stig 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 $600 million milestone and moving forward. 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?

Okay, Jason, thanks for the question. I'll start in answering them, and I'll let my colleagues contribute. So, on the TL1A, the Phase 3, there were no conditions around the Phase 3. The Phase 3 is about completing the Phase 2 and FDA approval to move into the Phase 3. So, that's what the deal is on. There's no criteria around that. So hopefully that's very clear. 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 Ellie can contribute. So you have seen, and Ellie 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. We're driving Estedo, making sure that brand is supported. appropriately, the same for your study of product we just launched in schizophrenia. And obviously, Eric and his team have started to hit the ground running, particularly on the Lanzapine and also TL1M recruiting, you know, faster than we expected. So that obviously incurs costs, but I think that's a good thing, particularly if that's part of our pivot to growth strategy. So those are the reasons why the OPEX probably has gone up uh there's a reason why it's gone up but we're pleased with them because it's it's in line with what we want to do um now obviously going forward just to give a bit of flavor for the opex on the r d obviously till 1a in partnership with uh sanofi will have a 50 percent of that cost taken by sanofi so as we move into next year and possibly depending where it closes this year we'll have a contribution from sanofi 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 TL18. Now we have this collaboration. And then the final part I'll say is, as we commented before, Revlimid was a contributor in Q3. We see that as a significantly less contributor in Q4, a very, very small part of that. So you take that into account. But, Eli, maybe you'd like to add a bit more flavor to that as well.

Yes.

So thanks, Jason. Overall, the way we need to think about it, we will end up, according to the guidance, with higher revenue versus last year. But we will trend the OPEX at the level of close to 26% of our revenue. And that's the way to think about it. 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 fervor mix that we'll have in that quarter. And that will drive our ability to sustain the EBITDA guidance, although OPEC is still increasing in terms of dollars.

Thank you, Jason.

Thank you. Our next question comes from Nathan Rich of Goldman Sachs. The line is now open. Please go ahead.

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 expenses, the 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 Uzetti, 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.

Thanks for the questions, Nathan. So 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 Abbott into Phase 3. We have Elantabine at full tilt in Phase 3, and obviously TL1A in Phase 2, which we're moving in. uh very aggressively so i think that's on purpose and that will continue i'll let ellie talk a bit about where we will be percentage of sales but obviously one thing to always consider which may be slightly new with tablets our sales we have shown that we've grown ourselves for the second quarter in a row and we are moving the business back to growth so obviously that does allow us some flexibility Although I want to assure you our focus on expenses is maniacal. So that's just something worth understanding. Fideli, do you want to give a bit more flavor?

Yes. So overall, the way to think about R&D, we're 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 more transparency here between 230 to 250, and that will be by itself very close to, I would 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 on February, but the way to think about it, it will be arranged between 6% to 6.5% of our revenue going forward according to our strategy, and this is mostly related to the mix inside the innovative piece in the R&D.

Thanks, Ali. And then moving on to Yosedi, and we talked a bit, I think, the questions around the positivity we have and then the next year. So I'll hand that to Sven, head of North American Gibson Flavor, for the excitement in the market.

Yes, thank you, Richard. So, we have a very good uptake. Our launch plan is full on track. We, of course, are working towards market access in hospital access, listing on hospital formularies. We are right on plan. And Medicaid and Medicare, we are also in discussions here. We have secured on-par access with Inveca Sustena in a couple of states, and we are walking towards 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. What is very encouraging for us is that the product profile that we hope for will find a good reception with positions actually plays out as planned. We've 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 receive more paid for prescriptions. But we get to, so today the majority of our patients from switches from oral therapies to USETI and then from within the category of switches from other LAIs to USETI. We have here sources of revenues that come primarily, of course, from the risperidone market, from Proceris and Constar, 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 the LAI segment will actually materialize. And for that reason, we believe that USETI will be then a material contributor to our in innovative medicines in 2024 and going forward from there.

Thank you, Sven. Thank you, Eli. Thank you for the question, Nathan.

Thank you. Our next question comes from Ash Verma of UBS. Your line is now open. Please go ahead.

Hi. This is Dee asking a question for Ash. Thanks for taking our questions. So I have two. The first one is on Oceto. 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 Offseto, Generics, or Ingresa? The second question is, can you give us a rough sense for what's the EBITDA margin for the standalone business? Also curious how that margin profile has been trending for the last few years. Thank you.

Well, thank you. I apologize I missed your name, but thank you for asking the question. I'll hand over the Estedo question to Sven who can give a bit more detail on that.

Yeah, thanks for the question. So if our 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 OsteoXR and the other two-thirds on 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 of these patient starts are round about half of them are naive patients that start neuron therapy for VMA2 inhibitor, and the other half come either from BID switches from instead of BID, or from Ingretza or tetrabenazine. So here, what is encouraging for us is that we have a significant number of new prescribers that have never prescribed Osteto before. They now start prescribing Osteto 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 Osteto continuous growth driver for our innovative business.

Thank you, Stan. And to your second question about TAPI and guidance on EBITDA for past and present and future, we are not giving any level of detail on EBITDA for TAPI at this moment. Thank you.

Thank you. Our next question comes from Glenet Santangelo from Jefferies. Your line is now open. Please go ahead.

Oh, yeah. Thanks for taking my questions. Just two quick ones for me. Obviously, with so much focus on the innovative pipeline, you know, generics often get overlooked. I mean, you know, Richard, it seems like the generics business, you know, 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. And then secondly, as it relates to the Alvatech partnership, You know, the company made an additional investment there, you know, in the wake of a number of CRLs, right, more recently on Solar. Could you give us an update, you know, on that relationship and the biosimilar pipeline as it relates to that Alvatech partnership? Thanks.

Thanks, Glenn. 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. And within North America, we've obviously seen a strong quarter there. I think Ellie did highlight that 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. I don't see those dynamics changing. There will be quarters where the pricing pressure is less, and there will 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 under Herrick Hughes on making sure we deliver our generics, 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 we'll ensure ourselves against this volatility within the market. So I think that's how we think about America going forward and how we think about making sure we stay competitive and have a sustainable business. With regard to Alvatech and the partnership, the relationship is actually very good. One of the things we did when we invested again into this partnership is, and I've said this before as well, Alvatech is very good when it comes to developing biosimilar R&D capability. I think we will have the best product on the market if we launch a mirror, both from a device point of view or a product profile interchangeability. They're very good at that. 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 FTA inspection, but also be able to deliver the volumes that we see will be necessary. And that's something which we're very capable of because we have 53 sites and we have roughly 30 FTA inspections a year, so we do know what we're doing. But I think maybe to conclude, the relationship is very strong. 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 the portfolio play, and also to ensure ourselves against the peaks and troughs associated with launching biosimilars one year and then maybe not having them the next. So hopefully that answers your question, Glenn, and I appreciate the call.

Yep, thank you.

Thank you. Our next question comes from David Amsalim of Piper Sandler. Your line is now open. Please go ahead.

Hey, thanks. So a couple of high-level questions just on overall strategy. you know, with the upfront payment in hand from Sanofi. So 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, you know, Beatrice 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.

thanks for the question david um so starting with the i think basically saying because our you know our financial situation improves with the tail one a deal and the five 500 million upfront um you know how do we think about pd so as i said we are thinking about dpd we're active you're looking we've hired angus grant a a seasoned professional, dare I say, legend in the industry who's worked in innovative medicines all his life. And so we really have stepped up that and our capability around that and our focus on that. Now, yes, we are targeting CNS and immunology, and within CNS, you do obviously psychiatry and urology because we see the synergy play there with 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, 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. With regards to the biosims question, I think our strategy is really clear. I think biosimilars has 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 Tuximab, 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 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 Tela. Thanks for your question, David.

Thank you. Our final question for today comes from Chris Schott of J.P. Morgan. Your line is now open. Please go ahead.

Hey, this is Katarina on for Chris. Thank you so much for taking our questions. so first on gross margins i know you're not giving guidance for next year but as we think about marching 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 ostito seems like the product has had a very strong quarter just let us 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 spent next year? Thank you so much.

Thank you, Karina. I'll take a go at both of those and then also allow my colleagues, Sven and Ellie, to contribute. So when we think about margin, the way I think about margin going forward is 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 grow it in areas where it will drive profitability at the top and the bottom line. Now, obviously, I think Elliot has just highlighted, and I highlighted in my comments, that we improved gross margin by 50 basis points. The way we did that primarily was our portfolio mix. So as we drive Esteto, as we drive Ejovi, as we drive Yosetti, as we bring Atlanta Peak to the market, ICS Sabah to 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. I'll let Eli give a bit more flavor if you want to, Eli.

Yeah, so just, you know, we are still actually aligned with our long-term financial targets by 2027 to reach the 30% on OP. which means if you look on our trajectory in OPEC, and as we are very, very cautious on even that we're actually dollar spend higher, but you're turning it always versus revenue this year and last year, and we believe that between 26 and 27% and OPEC going forward, which means that those gross margin of 55 to 57% on the long term should serve our goals.

And then moving on to Stedo. For Stedo, 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 Estedo 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. Let's understand what that takes. And then obviously manage that to 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?

Yes. I think one of the advantages that we have is, of course, that we can make synergistic investment between Osteto and Uceti because some of the prescribers that we target prescribes both of the brands. So we have leveraged 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 I believe the fact that the prescriber base increases as more and more physicians start prescribing VMA2 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.

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 a good evening. Thank you.

Thank you for joining today's call. You may now disconnect your line.