Viatris Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
August 8, 2024

Key Takeaways

  • Viatris reported Q2 2024 operational revenue growth of ~2% (its fifth consecutive quarter), with adjusted EBITDA up ~2%, EPS of $0.69, $426 million in free cash flow, and raised its 2024 new product revenue guidance to $500–$600 million.
  • The company completed its divestiture process in July, paid down ~$800 million of debt in Q2, holds over $3 billion in available cash, and expects to achieve a long-term 3x leverage target by year-end.
  • Viatris outlined three strategic pillars—its diversified base business, sector-leading cash flow for debt reduction and shareholder returns, and an expanding innovative portfolio featuring Selatogrel and Cenerimod advancing into FDA-fast-tracked Phase 3 trials.
  • It maintains a robust pipeline of over 250 generic and complex product candidates under development or review, supporting confidence in sustained new product revenue beyond 2024.
  • Government-mandated price cuts in Japan and Australia and lower EpiPen volumes due to formulary changes continue to pressure branded revenues in those markets.
AI Generated. May Contain Errors.
Earnings Conference Call
Viatris Q2 2024
00:00 / 00:00

There are 12 speakers on the call.

Operator

Good morning, everyone, and welcome to the Viatris Q2 2024 Earnings Call. All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask Please Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Bill Ciebliewski, Head of Investor Relations and Capital Markets. Please go ahead.

Speaker 1

Good morning, everyone. Welcome to our Q2 2024 earnings call. With us today is our CEO, Scott Smith CFO, Doretta Mistress Chief R and D Officer, Philippe Martin and Chief Commercial Officer, Kareem Olgaaf. During today's call, we will be making forward looking statements on a number of matters, including our financial guidance for 2024 and various strategic initiatives. These statements are subject to risks and uncertainties.

Speaker 1

We're also referring to certain actual and projected non GAAP financial measures. Please refer to today's slide presentation and our SEC filings for more information, including reconciliations of those non GAAP measures to the most directly comparable GAAP measures. When discussing 2024 results, we may concern comparisons to 2023 results on a divestiture adjusted operational basis, which excludes the impact of foreign currency rates and also excludes the proportionate results from the divestitures that closed in 20242023 from the 2023 period. When discussing our expectations for 2024, we'll be making certain comparisons to 2024 results on a divestiture adjusted operational basis, which excludes the impact of foreign currency rates and also excludes from guidance the results from the date of closing until the end of the period of the divestitures that closed in 2024. With that, I'll hand the call over to our CEO, Scott Smith.

Speaker 2

Good morning, everyone, and welcome to our Q2 earnings call. I'm pleased to announce we reported another strong quarter, our 5th consecutive quarter of operational revenue growth. We've had a great start to 2024 and with the completion of our in July, we are now an important inflection point for our company. 4 years ago, Beatrice embarked on a journey to build a new kind of healthcare company. By combining Mylan, a strong global generics company and Upjohn, a division of Pfizer with 20 of the most iconic off patent brands, Our goal was to build a unique global pharmaceutical company with the scale to bring patients access to high quality medicines worldwide.

Speaker 2

The team has done an outstanding job of executing the plan that was laid out when the 2 companies were brought together. Among the many accomplishments, we have integrated 2 global companies, simplified and streamlined the business by completing our divestitures, return the base business to growth, strengthened our balance sheet through significant debt pay down, return capital to shareholders through dividends and share repurchases, And importantly, we've already started to build our portfolio of innovative assets. As we move forward in the second half of the year and beyond, we want to accelerate growth and shareholder return by building on the strength of our base business with an expanding portfolio of innovative, best in class patent protected assets that have the potential for meaningful revenue growth and patient impact. I believe we have all the components necessary to successfully execute our vision, including an extensive global footprint that reaches 1,000,000,000 patients annually, a globally integrated company with deep capabilities in manufacturing, medical and regulatory affairs and commercialization, a robust development engine across a number of therapeutic areas sector leading cash flow generation from our base business to fund our vision and continue returning capital to shareholders. And we have added new skills, new capabilities and new areas of expertise to our already strong and talented executive leadership team.

Speaker 2

Doretta Mistress, our Chief Financial Officer Philippe Martin, our Chief R and D Officer and Corinne Legoff, our Chief Commercial Officer joined the team within the last year and are on today's call. All the great work over the last several years has put the company in a position to deliver on our future vision. As we move forward, we will focus on 3 strategic pillars. First, our diversified and growing base business. As we said, our extensive global footprint already reaches more than 1,000,000,000 patients every year.

Speaker 2

Our continued success in this part of our business comes from our large and diversified portfolio of generics and off patent brands that extends across markets and therapeutic areas. Here, we have a clear legacy of deep product knowledge and extensive commercialization and development expertise. 2nd, our financial strength and significant cash flow. Our strong balance sheet and sector leading cash flow generation differentiate us from our peers. Continue to deliver on our financial commitments, including debt reduction and returning capital to shareholders through dividends and share repurchases.

Speaker 2

With divestiture proceeds now in hand, we have a clear line of sight to meet our long term leverage target. And 3rd, our expanding innovative portfolio. This area represents an increasing focus on efforts to identify, vet and secure best in class patented assets. We are looking for assets that target significant unmet medical need in areas in which the company can be successful. By expanding in cardiovascular disease and immunology with solatego and cinerimod.

Speaker 2

We are making significant progress in accelerating the development of these assets. Additional leadership and scientific expertise we have brought in along with the impressive core of competencies in key areas such as global manufacturing, medical affairs, regulatory, legal and commercialization will all drive the success of this innovative portfolio. We are already making progress on these three pillars as evidenced by our strong results this quarter. I am pleased to report that in the 2nd quarter, we delivered total revenues of $3,800,000,000 and operational revenue growth of approximately 2%. Adjusted EBITDA was $1,200,000,000 and growing approximately 2% from a year ago.

Speaker 2

Adjusted EPS was $0.69 per share. 2nd quarter free cash flow was $426,000,000 excluding the impact of transaction costs and taxes. It is important to note that we delivered new product revenue of $210,000,000 in the quarter. With a strong second quarter results, we see momentum heading into the second half. As a result, we continue to expect 2024 year over year operational revenue growth of 2% and are raising our expected 2024 new product revenue range to $500,000,000 to $600,000,000 Now I'd like to turn the call over to Karen to share some of her observations from her first few months at Beatrice.

Speaker 3

Karen? Thank you, Scott. I have been with the company for about 4 months now. And based on what I've seen, I'm very excited about the opportunity ahead of us. I would like to share a few observations as I've gotten to know the global commercial organization.

Speaker 3

Our strong performance is a result of many puts and takes that only the diversity and the strength of our portfolio across geographies can allow. Our global commercial footprint is extensive. We have a presence in 165 countries and territories, which is an incredible platform to leverage as we continue to grow our base business and expand our innovative portfolio. We have a broad knowledge across many therapeutic areas and many of our branded and generic products are today's standards of care all over the world. This is a real differentiator as it demonstrates our unique ability to continue to drive volume and expand patient access at scale.

Speaker 3

As we prepare for additional innovative opportunities, we have a lot to build from. For example, if I think about Selatogrel, we are already leaders at rescue and emergency medicines in COPD, in asthma, in anaphylaxis. We have years of experience in educating patients to identify an attack and act in the moment. Plus, we have deep expertise in cardiovascular with a portfolio that treats a very large patient population from CV risk factors to CV events like thrombosis, MI and stroke. Finally, I love what I'm seeing in our teams.

Speaker 3

I am impressed with the agility and efficiency of the commercial organization. And I also see incredible energy, entrepreneurial spirit and proactivity to seize opportunities and make a difference in patients' lives. I am excited to continue to work with the entire team at Viatris on the tremendous opportunities ahead.

Speaker 2

Thank you, Karen. Your wealth of experience and global perspective have been invaluable as we continue to build the truly unique company we have envisioned. Now I'd like to turn the call over to Philippe to talk about our approach to R and D, both our base business and our innovative portfolio. Philippe?

Speaker 4

Thanks, Scott. I share the team's excitement about where we are today and where we are headed. I've had the opportunity to fully evaluate our R and D organization and further define our approach to innovation and growth. Our R and D strategy is driven by our deep in house development capabilities and 2 engines to fuel our growth, our base business pipeline and our innovative pipeline. Our base business pipeline provides Beatrice with a diverse and resilient growth engine.

Speaker 4

We anticipate a steady flow of core generics and an ever increasing flow of complex generics in novel 505(2) like product. This strong pipeline gives us confidence in achieving our new product revenue goals. Our focus for innovative pipeline is on expanding our patent protected portfolio of assets that have the potential for meaningful patient impact and the ability to address significant unmet medical need. I'm very impressed with the core competencies and talent we have at Viatris. In particular, our strong preclinical, clinical development and medical affairs teams across multiple therapeutic areas, our experienced manufacturing and device teams over a wide range of dosage forms and our proven regulatory, pharmacovigilance, legal and IP skills.

Speaker 4

This foundation is especially critical as we expand our innovative portfolio. We are identifying assets where we can leverage our expertise and global network and are assessing each opportunities based on specific criteria. We are looking for the ARIST innovative assets that address significant unmetical need. This includes having a validated mechanism of action, a strong clinical proof of concept and a clear path to regulatory approval. Xeladogrel and SINERMO are two great examples.

Speaker 4

Seladogrel has the potential to relieve the high disease burden of acute MI and specifically address the dire need for early intervention at the onset of symptoms. B2Y12 inhibition is a well established target in the treatment of MI with multiple products approved for chronic treatment. Our differentiated pharmacokinetic profile and unique mode of administration together with our robust Phase 2 data gives us high confidence in selatogrel as a self administered emergency treatment for recurrent MI. Our comprehensive, but simple Phase 3 study, SOS MI, has a special protocol assessment in place with the FDA and receive fast track designation. DENERIMO also has the potential to address a significant unmet medical need.

Speaker 4

SLE is a chronic and progressive autoimmune disease with limited treatment option and significant morbidity. Lenarimod, a novel S1P antagonist, has a unique mechanism of action targeting multiple aspects of lupus pathogenesis. A robust proof of concept was achieved in Phase 2 with data showing a highly differentiated safety and efficacy profile in a moderate to severe SLE patient population, similar to the patient population we expect to enroll in Phase 3. Cenerimod also has been granted fast track designation by the FDA and we have 3 comprehensive Phase 3 studies currently enrolling patients. With selatogrel and cenerimod now part of Beatrice, we're able to leverage our global R and D network to accelerate clinical trial recruitment.

Speaker 4

We've already significantly increased the number of sites we are targeting for both programs, adding approximately 250 clinical sites. We've also significantly expanded the geographic footprint, adding key countries like China, India and Japan to ensure a steady flow of patients. The team has been working hard to initiate these high recruiting sites and we anticipate that most sites should be able to recruit patients by the end of this year, early next year, which could shorten development timelines. The medical affairs team is also working hard to deepen relationship with KOLs and increase cinereimod and seladelgrav's presence at key medical meetings around the world like EHC, AACR and Aplar. And we are pleased to announce that the senerimod manuscript for the Phase 2 case study has been officially accepted for publication in the Lancet rheumatology.

Speaker 4

Another exciting innovative opportunity is with our eye care pipeline and is the enriched tear film gene therapy technology we acquired as part of the Oyster Point acquisition, which has the potential to treat a multitude of ophthalmic diseases. Importantly, this technology is not genome editing, but rather it leverages normal cellular processes and proteins to deliver therapeutics to the tier field. Our most advanced project called MR146 intended for the treatment of neurotrophic keratopathy or NK is reaching the IND stage with a validated therapeutic target for this disease. There is a significant unmet medical need for patients with NK to have a treatment that restores corneal structure and neurological function with minimal treatment burden. These examples from our expanding innovative portfolio combined with our robust base business pipeline energize me about the future and our ability to not only deliver on our vision, but also to address significant medical needs.

Speaker 4

I will now turn the call to Doretta.

Speaker 5

Thank you, Philippe, and good morning, everyone. To echo the comments from the team, we reported a strong quarter, and I want to spend some time walking through the highlights. But before I dive into the details, I want to take a moment to expand on our financial strength and how we think about it in the context of our overall strategy. 1st, we have built an extensive global footprint that already enables us to reach over 1,000,000,000 patients annually. We've successfully stabilized the base business and expect it to be a source of growth.

Speaker 5

And today, we have a broad and diversified portfolio across markets and therapeutic areas. 2nd, we have a strong balance sheet. We are committed to continuing to pay down debt and maintaining our investment grade rating and have a clear line of sight to reach our long term gross leverage target this year. And finally, our ability to generate significant cash flow is sector leading. This gives us the financial agility to fund our vision and continue returning capital to shareholders.

Speaker 5

Now on to the results for the quarter. Our 2nd quarter results demonstrate the power of what our portfolio can deliver. Operational revenue grew for the 5th consecutive quarter, up approximately 2%. This performance also carried through to adjusted EBITDA and adjusted EPS, growing approximately 2% and 3%, respectively. We also generated significant free cash flow of $426,000,000 in the quarter, which was in line with our expectations.

Speaker 5

This excluded transaction costs and taxes from the divestitures. Let's move on to discuss the performance of our base business, which grew operationally on a year over year net sales basis. Both Generics and Brands grew this quarter, up approximately 2%. The growth of our base business included new product revenue that was exceptionally strong with $210,000,000 in the quarter. The year to date performance and outlook give us confidence to increase our expectation for the year to a range of $500,000,000 to 600,000,000 This quarter, all of our segments grew operationally versus the prior year.

Speaker 5

In developed markets, net sales grew 1% and was driven by strong new product performance, including contributions from BRAENA, lisdexamphetamine and other generics in North America and Europe. In Europe, we are seeing durable growth across our diversified business. This is as a result of portfolio breadth across brands and generics, well developed market position and strong performance in key countries such as France. In North America, we saw continued growth in generics, which was up over 3% versus prior year. The portfolio is benefiting from complex products such as Wixela and Brana.

Speaker 5

And within our brands business, net sales continue to be impacted by increased Medicaid utilization in certain non promoted brands as well as lower EpiPen volumes resulting from formulary changes in the previous quarter. In Greater China, net sales growth was approximately 5% over the prior year. This was as a result of strong demand across multiple channels in China, including e commerce, retail and private hospitals. In emerging markets, net sales grew 7%, driven by the expansion of our cardiovascular portfolio in certain Latin American countries as well as strength in our MENA and Eurasia regions. These benefits help to absorb the ongoing impact of the therapy shift in the ARB market.

Speaker 5

And lastly, Jans grew approximately 1% over the prior year, benefiting from new products in Australia and volume growth of our promoted brands in Japan. This served to offset the impact from government price regulations in these countries. Turning to the P and L and free cash flow, this quarter serves as another demonstration of our financial strength and ability to generate significant free cash flow. Our segment and product mix led to stable adjusted gross margin. The performance was in line with our expectations of approximately 58%.

Speaker 5

With respect to operating expenses, we are continuing to invest behind the business to fund our growth, which includes investments across segments, Eye Care and in R and D. Free cash flow for the quarter was primarily impacted by lower adjusted EBITDA due to the closing of divestitures. Our free cash flow and existing cash on hand allowed us to strengthen our balance sheet with debt pay down of approximately $800,000,000 in the quarter. And as we look towards the rest of the year, we expect to have in excess of $3,000,000,000 in cash available for deployment. This takes into account divestiture proceeds received in the Q3, expected divestiture costs and our latest outlook for free cash flow.

Speaker 5

We expect the significant financial flexibility will allow us to pay down additional debt to reach our long term growth leverage target of approximately 3 times by the end of the year. We also expect to return capital in the form of dividends and will remain opportunistic with potential share repurchases and business development activity. Let's move on to items related to our financial guidance and key metrics for the remainder of the year. We expect our strong momentum to continue and as a result, we expect operational revenue growth of approximately 2% versus 2023 and stable adjusted EBITDA and adjusted EPS. Our expectation for the year is to be at the midpoint of the estimated guidance ranges.

Speaker 5

The assumptions driving total revenue growth include continued growth in developed and emerging markets and better than expected performance in Greater China and Jan and new product revenue of $500,000,000 to $600,000,000 as a result of the strong uptake of generic launches and additional new products. We are adjusting the following metrics across the P and L. Increase in adjusted gross margin range due to better segment mix and SG and A as a percentage of revenue is expected to be higher. This reflects the reduction in total revenues from the divestitures and the impact of dis synergies and costs of providing transition services. We expect certain costs associated with performing the transition services to be included in operating expenses.

Speaker 5

The transition income is expected to be recorded in non operating other income. A few comments on anticipated phasing for the 3rd and 4th quarters. Total revenue is expected to be slightly higher in the 3rd quarter, mainly due to normal product seasonality and adjusted gross margin is expected to moderate in the 4th quarter due to normal product and segment mix. Taking these factors into consideration, we expect adjusted EBITDA, adjusted EPS and free cash flow to be higher in the Q3. To summarize, the results for the quarter demonstrate our solid fundamentals, including our diversified and growing base business and our consistent significant free cash flow generation.

Speaker 5

We are well positioned for a strong second half of the year and expect to deliver on our capital allocation framework in support of the vision Scott laid out at the top of this call. And with that, I'll hand it back to the operator to begin the Q and A.

Operator

And our first question today comes from Ashish Verma from UBS. Please go ahead with your question.

Speaker 6

Hi, good morning. Thanks for taking our question. Congrats on all the progress. So I wanted to talk about 2025 dynamics a little bit. So I think the 2,300,000,000 free cash flow guide that you provided previously, what does that translate into EBITDA?

Speaker 6

Like if you look at the run rate that you've had sort of in the difference between EBITDA and free cash flow, it would roughly translate to $4,500,000,000 to 4.6 $1,000,000,000 Is that something that you would be comfortable with? And then secondly, on the new product revenues, yes, that's good to see you raising the guide there. Just what's driving that? Is that primarily the benefit that you saw VIBRENA or are there more products that you think that you're benefiting from? Thanks.

Speaker 2

Thank you. Thank you, Ash, and good morning. Thank you very much for the question. Sort of 2 parts here, right, talking about new product revenue, which is very important as we move forward here and we're very strong, we saw in the Q2 and we're expecting full year very strong new product revenue. And then also some 25 dynamics.

Speaker 2

I'll turn it over to Doretta to take those 2 for you.

Speaker 5

Great. Thanks, Ash. So yes, on new products, to your point, we feel great about the momentum we've seen from the new product perspective this year. This quarter we did $210,000,000 and then when you add that to the $154,000,000 that we did in the Q1, already year to date we're at $354,000,000 And so that in addition to the momentum that we're seeing broadly across our new product portfolio and it really isn't dependent on one product, one region. We've seen growth to your point in BRAENA and lisdexamphetamine.

Speaker 5

We've also seen growth in other generics in North America, but we've also seen new products in Europe and some additions in emerging markets in Jan. So as we look for the full year, the strong performance and the continuation of that really is going to be largely driven by products that we've already launched year to date and that's what gives us confidence in the $500,000,000 to $600,000,000 for the year. With respect to 'twenty five dynamics, listen, it's still early. We feel good about the momentum that we're seeing thus far in 2024. We see kind of the stability of our revenue growth.

Speaker 5

We are going to continue to invest in our business from a kind of R and D and investment perspective to fuel our growth. But the kind of dynamics in terms of what we've seen from our free cash flow, we kind of continue to see the $2,300,000,000 that you mentioned in terms of free cash flow generation and we're going to continue to kind of focus on our EBITDA conversion going forward. But with respect to 'twenty five, I think it's still too early to get into the dynamics specific to 'twenty five.

Operator

And our next question comes from Chris Schott from JPMorgan. Please go ahead with your question.

Speaker 7

Thank you so much. This is Ekaterina on for Chris and thank you for taking your questions. I'll start with a bigger picture one if I may. So just given that you're now done with the divestiture process, can you maybe talk about how you're thinking about the longer term profile of the company, both from a margin standpoint and a top line standpoint? And I guess where you see the most opportunity for the business from here?

Speaker 7

And then second question just on business development. I think you've touched upon this in the prepared remarks, but just what's your latest thinking in terms of business development and balancing development stage and commercial stage deals? And just what do you think makes the most sense for the company and maybe where you're seeing more interesting opportunities? Thank you.

Speaker 2

Yes. Thank you very much, Katrina, for the question. Again, I'll maybe address the second one first. From a BD perspective, we're engaged in a lot of different discussions. We're going to take a disciplined approach.

Speaker 2

As we got through the divestitures, sort of the net effect of that is that we're going to get to we've got line of sight and pay down our debt going into 25 and executing on our capital allocation plan 100 percent where we're giving back to shareholders at least $2,300,000,000 of free cash flow through dividends and share buybacks, but also taking a disciplined approach to business development. We've got a diversified company in terms of the number of therapeutic areas that we're in. We're looking at a number of different assets. We're looking at things which can help us supercharge our growth as we get into 'twenty five and beyond. We're very it's very important to understand that the base business is solid.

Speaker 2

The base business, we're showing operational growth. And then on top of that, we want to add, what I would consider significantly de risk type assets from an innovative perspective, assets that can help us drive growth future that are focused on unmet medical needs, that are patented, have long runways that we can invest in. But we're also going to shore up our base business as well. We're going to look for things currently marketed and different particularly in particular geographies that we can be effective in. And so we're going to do business development to shore up the base and we're also going to do business development to bring in new innovative assets into the company.

Operator

Our next question comes from David Amsellem from Piper Sandler. Please go ahead with your question.

Speaker 8

Hey, thanks. So just a couple from me, and I apologize if you addressed this since I joined late. Can you talk about overall your innovative brand strategy? I mean, you did an important in licensing earlier this year. I guess my question here is how aggressive do you want to be regarding adding innovative brands in the U.

Speaker 8

S. And developed markets broadly speaking. So that's number 1. Then number 2, can you just talk generally about complex generics and how we should think about contribution from complex products or new launches as we move through 2025 and they might be a little bit early to think about that, but wanted to get a sense of what key launches on the complex front that you're flagging or should flag? Thanks.

Speaker 2

Thanks, David. I think you used the language, how aggressive we want to be from a BD perspective. I think what we want to be is we want to be disciplined. There are we're engaged with a lot of companies. There's a lot of inbound that we've got both for things to help build the base business and in new innovative assets that we can take forward.

Speaker 2

And so, we're carefully looking at them all. We're really looking forward to getting into 'twenty five where we've got more capital to apply from a business development perspective. We want to build a pipeline of assets. You mentioned that we already did a deal and in license, Slava and Cinera, two products which will be very, very important to us. And we fully expect either as later in 2024, as we get into 2025, 2020 6, to continue to add assets to the pipeline, both again to shore up and to accelerate the growth that we're seeing in the base business.

Speaker 2

And secondly, to add to the innovative portfolio. We plan on doing both and I would say we want to do it in a smart and disciplined way. Philippe?

Speaker 4

Yes, regarding the complex generics, I think we as you can see on this presentation that we've provided, we have over 250 products in the pipeline that are either under development or under regulatory review. So we think we'll be we know we'll have a steady flow of complex generic coming in every year, this year in 2025 and so on. So we feel confident about our complex generic pipeline.

Operator

Our next question comes from Umer Raffat from Evercore. Please go ahead with your question.

Speaker 9

Hi, guys. Thanks for taking my question. I have a 2 part question on just broad investments. First, perhaps on GLP-one. Scott, I'm curious, what are your GLP-one aspirations?

Speaker 9

What's the capacity now? And what type of CapEx investments are you or are you not looking to make? Just thinking about that out loud. And also part 2 was the investment on Senerimod in lupus. I'm curious how you guys are thinking about that in light of some really groundbreaking data we're seeing with CD19 CAR Ts and presumably with bispecifics as well.

Speaker 9

And how do you put that in perspective relative to what we know on Cinerimod? That will be very helpful. And then finally, I think the prior question was on what are your complex generics in 25? I don't think I maybe I misheard. What are the complex generics in 25 launches?

Speaker 2

So thanks for question, Mark. There's sort of 3 parts there, right? Complex generics, cinerimod and how that fits into the therapeutic landscape as we move forward here in advances of the MAIDEN lupus and I think highly differentiated relative to CAR T constructs or bispecifics and other things. And then just a little bit on the overall GLP-one strategy. So I'll kick it over to Philippe from a pipeline and R and D perspective to address those questions.

Speaker 4

Yes. So from a GLP-one point of view, we are looking at developing multiple GLP-1s, semaglutide as well as liraglutide as well as Manjaro. So we are deep into the development of these assets from a supply chain standpoint. As you know, supply chain can be a little tight, but we've secured supply of API for all these assets and certainly have invested in our capability to manufacture these drugs going forward. So we anticipate we'll have a significant role going forward in that GLP-one market.

Speaker 4

Regarding Cinerimod, I think if you were to compare the Cenimod benefit risk profile versus the one we anticipate from the CAR T or the bispecific, you'll see that we anticipate to be in the higher end of efficacy with a safety profile that is clearly differentiated. CAR Ts and bispecific are typically having significant safety baggage. And so we anticipate that our benefit profile will be very different, which will allow us to be placed prior to the use of either a by specific biologics or CAR Ts going forward. I'm not even talking about the convenience factor of having an oral drug versus these CAR Ts that can be quite difficult to administer. And then on the last one on the complex generic, I think I wouldn't highlight one specific product.

Speaker 4

I think it's the breadth of the pipeline that we have that we see will be delivered this year for the rest of the year, 'twenty five percent, 'twenty six percent. So we feel very confident in our new product revenue, as you can see, and we anticipate the same going forward.

Operator

Our next question comes from Balaji Prasad from Barclays. Please go ahead with your question.

Speaker 10

Thank you. Hi, good morning and congratulations on the quarter. A couple of questions from me. Could you comment around the magnitude of the expected base business erosion from government price regulations in Japan and Australia? I presume in Japan, it's the annual price cuts or are there any other dynamics at play?

Speaker 10

2nd, could you comment around the split between the innovative pipeline and non innovative pipeline currently? And with the improvement in cash metrics, how do you see the spend on innovative R and D progressing into the next couple of years? Or do you intend to keep it at a similar percentage? Thanks.

Speaker 2

Thank you very much, Bellagio. I'll take the first question over to Doretta to talk about the dynamics that we're seeing in Australia

Speaker 5

and Japan, etcetera. Yes. To your point, Balaji, we aren't seeing anything kind of that it really is driven by the ongoing price normal government price declines that we're seeing in Japan and Australia. Now the offset to that is we actually have seen better volume in Japan as well and given that Japan is actually and the broader Jans region is actually performing better than our expectations for the year.

Speaker 2

And relative to your question on R and D spend and where we're going from an R and D perspective, maybe I'll make a general comment and Philippe can comment as well here. But we're going to continue to invest in both the base business, the base generics, complex generics and others. And in the innovative pipeline, we've already, talked about here, brought in a couple of new innovative assets through our business development activities, through the global healthcare gateway and others. We're going to continue to bring in assets and continue to develop them. So, you might see some movement in the distribution of that spend as we bring in more innovative assets.

Speaker 2

But we're going to continue to invest in all components of the base business and in new innovative assets as we move forward. Okay. Thank you.

Operator

Our next question comes from Jason Gerberry from of America. Please go ahead with your question.

Speaker 11

Hey, guys. This is Bhavan Patel on for Jason Gerberry. My first question is, can you approximate the full year 2024 EBITDA contribution from divestitures that provided partial first half twenty twenty four contribution? Just so that we can understand the RemainCo business profile and model appropriately headed into 2025 and onwards. And then my second question is, given all the changes in the portfolio relative to reported financial results in 20222023, do you see low 30% EBITDA margins similar to certain peers like Organon as a good long run assumption, pending any breakthroughs on the pipeline side, of course.

Speaker 11

And with regards to your pipeline, is there a timeline update based on new enrollment strategies for the Phase 3 solatigrol SOS AMI trial? Thank you.

Speaker 2

So I'll thank you very much for the question. I'll ask Durek to address the first part of your question, then I'll talk about the for Salat Agro and Cinerimod later.

Speaker 5

Great. Thank you. And on the divestitures, I think as we've laid it out when we started the year, the way we've approached it is as we close the divestitures, we've adjusted and taken out the kind of impact from our and provided the impact from our actuals and then also adjusted our guidance going forward to reflect those divestitures. And we'll continue to do that now that the divestitures are behind us as we get through the back half of the year and we look into 2025, we will be providing that additional kind of detail as we move into the rest of the year. But as we had in our earnings presentation and our press release, we do lay out the components of both the divestitures that have closed as well as the impact to our guidance and our results.

Speaker 5

With respect to margins, I mean, I think as we think about the business, we have confidence in both our base business growth as well as the stability of our EBITDA margins as we continue to invest in growth. But as Scott laid out, as we continue to invest in the business, bring in more patent protected innovative assets, we have the opportunity to continue to expand the business. But I think we feel good about the stability of our EBITDA.

Speaker 2

And then relative to pipeline acceleration on the innovative assets, I'll say that we're very, very excited obviously with both Salatogro and Cinerimod. As I said in my prepared remarks, we're already making significant progress and doing the things we need to do to accelerate the development of these assets and move the timelines forward. I don't have a specific update for you on the date. We want to get in and do some remediation further, continue to open new sites, continue to invest in the development. And then by the time we get into the New Year, we'll be able to be in a better position to give you sort of specifics on where we think those timelines are going.

Speaker 2

But we think we're going to significantly be able to help and accelerate the development timelines. And again, we'll look to update those timelines as we get into 2025.

Operator

And ladies and gentlemen, with that, we'll conclude today's question and answer session. I'd like to turn the floor back over to Scott Smith, CEO, for closing remarks.

Speaker 2

Thank you, everybody, and thank you to the operator. In closing, it's been a great year for us so far. With the completion of our divestitures in July, we're the turning point for the company. We have built a strong foundation. We have a bold vision for our future and we have the key ingredients we need to be successful to deliver on our goals.

Speaker 2

Thank you all very much for your attention.

Operator

Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We thank you for joining. You may now disconnect your lines.

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