Bitfarms Q3 2024 Earnings Call Transcript

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Provided by Quartr
November 7, 2024
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Operator

Good morning, everyone, and welcome to the Viatris Q3 twenty twenty four Earnings Call. All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask questions. Please also note, today's event is being recorded. At this time, I'd like to turn the floor over to Bill Ciebluski, Head of Capital Markets.

Operator

Please go ahead.

Bill Szablewski
Bill Szablewski
Head of Capital Market at Viatris

Good morning, everyone. Welcome to our Q3 2024 earnings call. With us today is our CEO, Scott Smith CFO, Doretta Mistress Chief R and D Officer, Philippe Martine and Chief Commercial Officer, Kareen O'Gaugh. 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.

Bill Szablewski
Bill Szablewski
Head of Capital Market at Viatris

We will also be 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 actual or reported results, we will be making certain comparisons to 2023 actual or reported 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 will be making certain comparisons to 2024 actual or reported results on a divestiture adjusted operational basis, which excludes the impact of foreign currency rates. We may refer to those as changes on an operational basis.

Bill Szablewski
Bill Szablewski
Head of Capital Market at Viatris

With that, I'll hand the call over to our CEO, Scott Smith.

Scott Smith
Scott Smith
CEO at Viatris

Good morning, everyone, and welcome to our Q3 earnings call. I'm very pleased to report that we had an outstanding quarter, continuing the strong momentum we've seen all year. We have achieved our 6th consecutive quarter of operational revenue growth and have delivered growth across adjusted EBITDA and adjusted earnings per share. In addition, we made significant strides in all three of our strategic pillars we laid out earlier this year. Our diversified and growing base business, our financial strength and significant cash flow and our expanding innovative portfolio.

Scott Smith
Scott Smith
CEO at Viatris

Beatrice is not only stronger and more streamlined, but more importantly, our future direction is now clear and more focused. We are in a period of consistent base business growth and we expect this momentum to continue into next year. I'm happy to report that in the Q3, we delivered total revenues of $3,800,000,000 which represents operational revenue growth of approximately 3%, adjusted EBITDA of $1,300,000,000 growing approximately 4% from a year ago and adjusted EPS of $0.75 per share, growing approximately 6%. We had a very strong quarter of free cash flow generating $866,000,000 excluding the impact of transaction costs and taxes. New product revenues were also strong at $133,000,000 in the quarter.

Scott Smith
Scott Smith
CEO at Viatris

We delivered on our commitment to use the proceeds from our divestitures to pay down debt, repaying approximately $1,900,000,000 in debt and putting us firmly on track to achieve our long term gross leverage target. With this milestone, the company is operating from a position of strength and has a clear and focused outlook that centers on capital allocation. We believe that how we prioritize capital allocation going forward will be the single most critical factor in optimizing and maximizing shareholder value and in driving future growth. Returning value to shareholders through dividends and share repurchases will remain a central element of our plan. In 2025, we expect to be more aggressive on share buybacks given our current valuation level.

Scott Smith
Scott Smith
CEO at Viatris

This will be balanced with making disciplined investments in commercialized or late stage assets through regional and global business development that leverage our unique commercial and R and D infrastructure to drive our future growth. We expanded our innovative portfolio of patent protected assets by entering into an exclusive licensing agreement with Lexicon Pharmaceuticals for sotagliflozin in all markets outside of the U. S. And Europe. With this licensing agreement, we are continuing to build on our strong presence in cardiovascular disease, which already includes approximately $2,500,000,000 in annual revenue as well as solategrel, which we licensed earlier this year.

Scott Smith
Scott Smith
CEO at Viatris

This agreement leverages our global healthcare gateway, which provides partners with access to our unique global infrastructure. We believe we will be able to leverage our experience in cardiovascular disease our infrastructure to execute on the potential of soda. This quarter is a great demonstration of the power of a stronger, more streamlined Viatris. We are seeing good performance from our base business as demonstrated by our strong track record of delivering new product revenues and by our operational revenue growth over the past few quarters. We expect this momentum to continue into 2025.

Scott Smith
Scott Smith
CEO at Viatris

Now, I'd like to turn the call over to Philippe to share an update on our pipeline. Philippe?

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Thanks, Scott. Our strong track record in delivering on our new product revenue is driven by the reliability of our base business pipeline. This diverse growth engine generates a steady flow of core generics, complex generics and novel products. Our focused execution on this robust pipeline gives us confidence in our ability to continue to grow our base business and address unmet medical needs. Effexor is a great example.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Last month, we announced positive top line results that demonstrated the efficacy and safety of Effexor for the treatment of generalized anxiety disorder or GAD in Japanese patients with moderate to severe disease. We believe this significant life cycle opportunity has the potential to be a meaningful treatment option for patients with GAD, a condition which currently does not have any approved treatment available in Japan. We are targeting to submit our application to the Japanese health authorities in 2025. The growth of our base business is critical for us to be able to reinvest in our innovative pipeline as we look for opportunities which can make a meaningful difference in patients' lives. We also have the unique opportunity to leverage our global development expertise and broad commercial infrastructure.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Sets like setagliflozin or Impefa represent a good strategic fit for us. IMpefa was previously approved by FDA to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visits in adults with heart failure or type 2 diabetes, chronic kidney disease and other cardiovascular risk factors. We believe that Impeza is a differentiated asset that offers a broader label compared to SGLT2 inhibitors and a unique mechanism of action with dual SGLT inhibition potentially contributing to the unique safety and efficacy profile of the drug. Our plan is to leverage the FDA approval as a reference in certain ex U. S.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Markets and conduct clinical studies where needed to expand patients reach. We also believe there is a potential for expansion into further indications, which could include hypertrophic cardiac biopathies. Further, Beatrice has a strong legacy in cardiovascular diseases through our portfolio that expands across the overall cardiovascular continuum from reducing risk factors to improving patient outcomes with well known products like Lipitor, Norvasc and CADUET, in addition to our expertise in the area of thrombosis with products like Arextera and Fraxiparin. With this legacy and broad portfolio also comes very strong relationship the medical community, which we're tapping into as we progress our selatogrel program. I've provided details about selatogrel in sineremod on our last call, but let me share a brief status update.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Our recruitment effort for both our ASMI clinical trials and our OPUS clinical trial are progressing well. The development for each asset is on track and aligned to our previous communicated timelines. In addition, we are working on expanding sineiimod indications by initiating a registration program in lupus nephritis. And finally, as part of our innovative pipeline, we are continuing to advance our ophthalmology program with 3 key registrational relays expected in 2025. I'm proud of the work to date across our entire R and D platform and believe we'll continue to make an impact for many years to come by harnessing the combination of both our base business and innovative pipeline.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

And with that, I'll turn it over to Loretta.

Doretta Mistras
Doretta Mistras
CFO at Viatris

Thank you, Philippe, and good morning, everyone. Building on Scott's earlier comments, this has been an exceptionally strong quarter and our 1st full quarter on an ex divestiture basis, the results of which are highly encouraging and indicative of the strong momentum we anticipate carrying into the New Year. We're pleased to report our diversified base business grew 3% year over year, marking our 6th consecutive quarter of operational revenue growth. This performance also carried through to adjusted EBITDA and adjusted earnings per share, which grew approximately 4% and 6%, respectively. We generated significant free cash flow of $866,000,000 excluding the impact of transaction costs and taxes, which enabled us to continue strengthening the balance sheet by paying down debt.

Doretta Mistras
Doretta Mistras
CFO at Viatris

Going forward, we have a strong foundation to execute on our 3 strategic pillars. As I review the highlights for the quarter, to note, my commentary on segment performance will be on a divestiture adjusted operational basis. Growth of our base business revenue was up 3% year over year. And once again, all of our segments grew versus the prior year. We had strong performance from brands, up 2% and from generics, up 4%.

Doretta Mistras
Doretta Mistras
CFO at Viatris

Brand performance included expansion of our cardiovascular portfolio in certain Latin American countries and strong growth in Europe and Greater China. Generics growth was attributable to strength in our broader European portfolio, complex products in North America and strong volume performance across the Jans region. New product revenue was $133,000,000 for the quarter, bringing the total to $497,000,000 year to date. We remain confident we will be at the higher end of our range of $500,000,000 to $600,000,000 for the year. In Developed Markets, net sales grew by approximately 3%, driven by robust strength in our generics business.

Doretta Mistras
Doretta Mistras
CFO at Viatris

In Europe, we saw another quarter of durable growth across our diversified business, up 6%, driven by contributions from new products and strong Generics performance in key countries, including France. In North America, we saw another quarter of growth in generics, up 5%, benefiting from complex products such as BRAENA and Wixela as well as from lisdexamphetamine. Within our brands business, net sales declined from the continued impact of Medicaid utilization in certain non promoted brands and lower EpiPen volumes resulting from the formulary changes which occurred earlier in the year. In Greater China, net sales grew approximately 3% over the prior year. This was as a result of continued strong volume growth across multiple channels, including e commerce, retail and hospitals.

Doretta Mistras
Doretta Mistras
CFO at Viatris

In emerging markets, net sales grew 2%, driven by the expansion of our branded cardiovascular portfolio in certain Latin American countries and strength in our MENA and emerging Asia regions. These benefits help to absorb supply chain impacts affecting our ARV generics business. And lastly, Jan's grew approximately 8%, benefiting from new products in Australia and volume growth from our promoted brands in Japan. Turning to the P and L and cash flow. Adjusted gross margin was stable at approximately 58.5% and operating expenses were roughly flat over the prior year, both in line with our expectations.

Doretta Mistras
Doretta Mistras
CFO at Viatris

Free cash flow for the quarter, excluding transaction costs and taxes, grew 10%, driven by higher adjusted EBITDA and lower working capital. This significant free cash flow and cash from divestitures enabled us to continue executing on our debt repayment plan. We repaid $1,900,000,000 of debt, including the $325,000,000 that was repaid in October, bringing our notional debt outstanding below $15,000,000,000 and line of sight to below $14,000,000,000 by year end. Following the upcoming repayment of approximately €1,000,000,000 at maturity in November, we expect to exit the year at approximately 3x gross leverage and we will have successfully completed our deleveraging efforts and achieved meeting our long term growth leverage target at year end. Going forward, we plan to operate within our long range target of 2.8 to 3.2 times.

Doretta Mistras
Doretta Mistras
CFO at Viatris

This positions the company with a meaningfully stronger balance sheet and a continuing investment grade rating, all of which will serve as the foundation of our capital allocation decisions going into next year and beyond. Turning to the remainder of the year. We are reaffirming our outlook with full year 2024 base business operational revenue growth of approximately 2% and flat adjusted EBITDA and adjusted earnings per share versus last year. We have revised these earnings ranges solely to reflect the impact of IP R and D related to the sotagliflozin licensing agreement incurred in October. A few comments on sequential phasing for the Q4.

Doretta Mistras
Doretta Mistras
CFO at Viatris

Total revenue is expected to be lower for the following reasons normal product seasonality in developed markets and Greater China region, phasing of certain generic products in North America and generic entrance in our cardiovascular products in Jans. Adjusted EBITDA and adjusted earnings per share will be impacted by a step down in adjusted gross margin due to normal product and segment mix and an increase in adjusted SG and A due to timing and normal cadence of investment. And lastly, free cash flow in the 4th quarter is also expected to be lower due to the impact from divestiture costs and taxes, higher CapEx and semiannual interest payments. I would note that these trends are all consistent with our expectations and prior periods. In summary, we believe these results demonstrate our encouraging fundamentals from our diversified and growing base business, which continues to produce significant free cash flow.

Doretta Mistras
Doretta Mistras
CFO at Viatris

The prudent work we have done on strengthening the balance sheet provides us with a strong foundation as we pivot to a more balanced capital allocation strategy of funding our vision and returning capital to shareholders. But before I conclude, given the level of investor interest in modeling our Salatogrill and Cinerimod assets, we are providing a workbook as part of our Q3 earnings package that can be found on our investor website. And with that, I'll hand it back to the operator to begin the Q and A.

Operator

Ladies and gentlemen, at this time, we will begin the question and answer Our first question today comes from Glenn Santangelo from Jefferies. Please go ahead with your question.

Glen Santangelo
Glen Santangelo
Managing Director at Jefferies Financial Group

Yes. Good morning. Thanks for taking my question. Hey, Scott, I have just two quick questions for you. The first one is a lot of comments around the base business continuing to have strong momentum and that sort of continuing into 'twenty five.

Glen Santangelo
Glen Santangelo
Managing Director at Jefferies Financial Group

And I appreciate you don't want to give any forward guidance, but when we look out over the next couple of years, is that sort of $500,000,000 contribution from new product revenues? You're obviously generating a little more than that this year, but is that sort of the right zip code for us to think about as a starting point for the next couple of years? And then secondly, on the capital allocation, the company said repeatedly that you want to use half the free cash flow for business development and the other half, you want to return to shareholders through repurchases and dividend. Is sort of getting the leverage down to 3x by the end of the year, is that the trigger to start that? And based on what you see in the market with respect to business development versus be interest trading at only 6x EBITDA, does that push you one way or another as you move into 2025?

Glen Santangelo
Glen Santangelo
Managing Director at Jefferies Financial Group

Thanks.

Scott Smith
Scott Smith
CEO at Viatris

Thank you very much for the questions, Glenn. So for the first one, yes, with the base business, we're not guiding into 2025, but we see the base business continuing to generate and continuing to have momentum similar to what we have this year. We think we can generate and we have historically since 2020 generated $450,000,000 to $550,000,000 in new product revenue every year and we expect that to continue. And yes, to your second question on capital allocation, I think getting to 3x is very, very important for us. That will allow us to be able to use $2,300,000,000 in free cash flow at minimum to give half back to shareholders through dividends and share buybacks.

Scott Smith
Scott Smith
CEO at Viatris

We're trying to be more aggressive on share buybacks as we move into 'twenty five and beyond because we'll be at that desired leverage ratio. And we want to also be doing some disciplined business development focusing on in market or near market assets. So, yes, getting into 25%, getting that leverage ratio right really is a springboard for us to be able to execute on our capital allocation strategy in 2025 and beyond.

Operator

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

Jason Gerberry
Jason Gerberry
Analyst at Bank of America

Hey, guys. Thanks for taking my questions. Couple for me. We saw 1 multinational company operating in China recently get investigated regarding some reimbursement matters. I'm just trying to get a sense from your perspective if that's an isolated incident

Jason Gerberry
Jason Gerberry
Analyst at Bank of America

or if

Jason Gerberry
Jason Gerberry
Analyst at Bank of America

this is part of some broader effort around cracking down on different reimbursement practices. It would be helpful if you can just offer any color around that. And then, I didn't apologies if I didn't hear this, but were there any updates just thinking about sandostatin LAR and potential to get that approved in the near term and status of the GA Depot resubmission? Thanks.

Scott Smith
Scott Smith
CEO at Viatris

Thank you, Jason. I will take the first question on China and then Philippe can fill you in on your new product question. So we don't have any direct comment on any investigation that's going on in another country. We as a leadership team were just in China last week and meeting with the affiliate there. As an organization, we hold ourselves to the highest standards possible.

Scott Smith
Scott Smith
CEO at Viatris

We've got a strong compliance organization in China. We've got strong overall structure in China and a very strong affiliate. We've developed deep and strong partnerships within the healthcare community there. And we feel very, very strongly about our business in China overall.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

And this is Philippe regarding your second question. GA Depot, we have a meeting scheduled with the agency in mid December. And so we'll be in a better place to give you an update of next year once we hear from FDA. And then regarding, I think your question was about Sandostatin. Yes, we are still going through FDA review for this product and we expect we'll be in a position to launch the product next year.

Operator

Our next question comes from Chris Schatz from JPMorgan. Please go ahead with your question.

Ethan Brown
Ethan Brown
Equity Research Analyst at JP Morgan

Hi, this is Ethan on for Chris. Thanks for taking our questions. First off, just if we look at the deals that you've done this year between the Adorsia and the SGLT2 transactions,

Ethan Brown
Ethan Brown
Equity Research Analyst at JP Morgan

is this the type of the deals that

Ethan Brown
Ethan Brown
Equity Research Analyst at JP Morgan

we should expect going forward in terms of size and scale? And then secondly, just looking to 2025, any initial color on your 2025 expectations for EBITDA and how we should be thinking about the pushes and pulls there? Thank you.

Scott Smith
Scott Smith
CEO at Viatris

Yes. Thank you, Ethan, for the question. Good morning. And I'll take the first one and then I'll push to Doretta to talk to you about EBITDA going forward. The Idorsee transaction was a little bit of a transaction of opportunity.

Scott Smith
Scott Smith
CEO at Viatris

It's a little bit of an earlier deal than I think it will be normal for us going forward. These were our products that were in Phase 3 development. I think very, very good positive assets. We felt like we contribute to the continued development of them. We think they've got the potential to be blockbusters if the data comes in positive globally.

Scott Smith
Scott Smith
CEO at Viatris

So that was a deal of opportunity for us. I think we're really focused right now on doing disciplined business development. We want to really focus on in market or near market assets, things with which we can leverage our global healthcare gateway. We've got a very strong global infrastructure, and we want to be able to

Scott Smith
Scott Smith
CEO at Viatris

deliver assets that can drive some

Scott Smith
Scott Smith
CEO at Viatris

revenue in the and we want to be able to deliver assets that can drive some revenue in the 'twenty five, 'twenty six, 'twenty seven timeframe. And in terms of size of the deal, yes, I think that's the type of deal we're looking. I think we're hoping to add multiple different assets over the next couple of years to the pipeline. And again, we're focusing on very disciplined business development with in market or near market assets.

Doretta Mistras
Doretta Mistras
CFO at Viatris

And thanks on 2025 questions. Yes, we're not going to be providing forward looking revenue and EBITDA guidance, but just to your point, just to give you a sense of some of the pushes and pulls. Scott commented earlier on the momentum that we're continuing to see from the base business on the revenue perspective and how we expect that to continue at the top line. From EBITDA and EPS perspective, we are currently working through the adjustments post the divestitures from a stranded cost TSA perspective. But going into next year, we are focused on really prioritizing adjusted EBITDA stability and so we're really balancing the growth of the business but making the necessary investments in R and D and commercial that can drive our future growth.

Doretta Mistras
Doretta Mistras
CFO at Viatris

And I would say we'll continue to work and provide clarity and provide really an apples to apples comparison when we provide our 'twenty five guidance. But we do see things reasonably calibrated in the models and we also feel confident in our cash flow of $2,300,000,000 and we'll provide more color as we get into next year.

Operator

And our next question comes from Ash Verma from UBS. Please go ahead with your question.

Ashwani Verma
Ashwani Verma
Executive Director at UBS Group

Yes. Thanks for taking my questions. Good to see some steady progress here. Just a capital allocation question. So with both the debt pay down that you were sort of driving towards behind you and the stock trading at like sub-4x, a 1000000 gigabytes, like how do you think about balancing business development investments and share repurchases?

Ashwani Verma
Ashwani Verma
Executive Director at UBS Group

And then secondly, for emerging markets, yes, I saw this like ARV supply chain impact. I think you have talked about this for a little bit of time. Just curious like when does this start to lap that we don't see this as a drag on the business going forward? Thanks.

Scott Smith
Scott Smith
CEO at Viatris

Thanks, Ash, and good morning. And I'll take your first question again and Doretta can pick up your second question. Yes, we've got line of sight on getting our debt repayment right to the right spot of the target that we have talked about at a leverage ratio of approximately 3% and 3.0%. And we see that very, very closely to us and we've got great line of sight on that. That definitely then allows us to move into our capital allocation, implementing the full capital allocation strategy, minimum of $2,300,000,000 in free cash flow, half of that to shareholders in terms of dividend and share buyback, the other half in terms of business development and building the pipeline, doing that in a disciplined way.

Scott Smith
Scott Smith
CEO at Viatris

I think given the share price and the valuation of the company right now, we might be a little more aggressive on the share buyback side than on the BD side going into 'twenty five. But we're looking at a 3, 4, 5 year period where approximately half going to return to shareholders and half to BD. But I think implicit in your point is this idea of the valuation of the company. And given that, I think we see a nice opportunity as we move into 'twenty five to be more aggressive in terms of share buybacks.

Doretta Mistras
Doretta Mistras
CFO at Viatris

And with respect to the ARB business, historically, we have made comments around just therapy shifts that have been ongoing in the business. However, my comments this quarter were really specific to some delays that we saw in the supply of ARB products and we are currently working to catch up on backlogs across ARB and across our ARB portfolio and that's what we're working through. Those are what my comments were referring to.

Operator

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

David Amsellem
David Amsellem
Sr. Research Analyst at Piper Sandler Companies

Thanks. Well, I don't want to belabor the topic of new launch contribution for 'twenty five and I know that you've sounded a note of confidence regarding impact from new launches. I did want to drill down a little more because it does feel to me that there is less in the way of transparency regarding new products going forward than there has been historically. So one question I had is, you've talked historically about products like Sandostatin LAR, you talked about Victoza as contributors. Can you talk to how much products like that are going to be contributors for next year?

David Amsellem
David Amsellem
Sr. Research Analyst at Piper Sandler Companies

Other products like iron sucrose, Venofer, is that going to be a contributor? You talked about glucagon, injectable glucagon in the past. Is that going to be a contributor? And then also one of your competitors, Teva, has talked about potentially entering the Symbicort market next year. Wondering if you can talk to potential competitive dynamics regarding Symbicort.

David Amsellem
David Amsellem
Sr. Research Analyst at Piper Sandler Companies

So I know there is a lot there on specific products, but hoping to get granularity. Thank you.

Scott Smith
Scott Smith
CEO at Viatris

Thank you, David. Thank you for the question and good morning. Just from a macro level, we feel very good about the new product numbers. Traditionally, we have if you take a look over the last 4 or 5 years, we've delivered $450,000,000 to 5 $50,000,000 in new product revenue every year. This year, we're at the high end of it.

Scott Smith
Scott Smith
CEO at Viatris

We believe we're doing very, very well in terms of the number of submissions and the number of products approved overall, and we feel very confident in those numbers going forward. To get to your sort of specifics around individual products, I'll ask Philippe to comment.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Yes. Thank you, Scott. So I think as Scott said, we are very confident about

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

$450,000,000 to $550,000,000 next year. And this includes carryover from 2024, generic launches in North America and Europe. And to your question specifically, it includes complex products such as glucagon, iron sucrose and liraglutide. So these three products are clearly in the mix for next year. And we are continuing to work on that broad portfolio and bring over a significant number of submissions every year.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

So again, we can only reiterate the fact that we're very confident about this $450,000,000 to $550,000,000 500,000

Corinne Le Goff
Corinne Le Goff
Chief Commercial Officer at Viatris

And David, on your comment on additional generic competition on SYMECOR in this area. What I can say is that first, we are very pleased with the execution and performance of Brenna, which is our complex generic that plays in this market. We have currently about 15% TRx market share, and we expect that Brenna will continue to deliver growth for us going into 2025. So again, a good example of having

Corinne Le Goff
Corinne Le Goff
Chief Commercial Officer at Viatris

had

Corinne Le Goff
Corinne Le Goff
Chief Commercial Officer at Viatris

the possibility to launch early as a complex generic in this market and to be able to deliver more driven and sustainable value.

Scott Smith
Scott Smith
CEO at Viatris

Thank you, Corinne.

Operator

And we do have an additional question and this comes from Balaji Prasad from Barclays. Please go ahead with your question.

Balaji Prasad
Balaji Prasad
Analyst at Barclays Capital

Hi, good morning. Just two sets of questions for me and apologies if one of them are both have been asked earlier. Firstly, could you comment about sertagliflozin in terms of the contributions and the number of markets that you plan to launch in the next 1 to 2 years? And how should we think about modeling this into our thoughts? Secondly, a big picture thematic question with the new administration, it's likely that we could see a pushback towards making America.

Balaji Prasad
Balaji Prasad
Analyst at Barclays Capital

I want to understand how could that change your priorities towards the U. S. Generics market? Is this something that you will want to refocus or increase in terms

Balaji Prasad
Balaji Prasad
Analyst at Barclays Capital

of

Balaji Prasad
Balaji Prasad
Analyst at Barclays Capital

focus and future revenue contributions from this region? Thanks.

Scott Smith
Scott Smith
CEO at Viatris

Yes. Thank you, Balaji. And I'll take the macro question and then Philippe and Karim can talk a little bit more about sort of the flows. From a macro perspective, far too early for us to be able to fully understand healthcare implications. We're here.

Scott Smith
Scott Smith
CEO at Viatris

We will work positively and productively with the Trump administration as we would with any administration going forward. But it's far too early to understand healthcare implications at this point in time, but we're interested to understand what's ahead and very optimistic about what the years look like for us in 'twenty five and beyond. Thanks.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Regarding soda, I think we are what we're going to do is leverage the US approval and get the drug registered in several large emerging markets, Canada, Australia, New Zealand, for which there's a very clear straightforward path to approval. In Asian markets like Japan and China, it might require another clinical study. And so we'll be discussing with these health authorities over the next few months and put a development plan together for this. So we expect that soda will start contributing to our revenue growth in around 2027, but I'll turn it over to Corinne for more color.

Corinne Le Goff
Corinne Le Goff
Chief Commercial Officer at Viatris

Yes. Thank you. So I'm not going to comment on the overall size of the opportunity, but what I can say is that Stagliflozin fits perfectly with our cardiovascular infrastructure in the regions where we'll be launching this product. I mean, you should know that we have about $2,500,000,000 of annual revenues in cardiovascular diseases. So we have in place the appropriate infrastructure to be able to promote these assets across the region.

Corinne Le Goff
Corinne Le Goff
Chief Commercial Officer at Viatris

And we look at the effect of Bifrostene as a franchise that will as Philippe said, starting revenue in the year 2020, 'twenty seven, but will generate growth through the end of the decade.

Operator

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

Scott Smith
Scott Smith
CEO at Viatris

Thank you very much and thank you for everybody on the call. In closing, it was another great quarter. I'm proud of our team and of our continued strong performance. We have great momentum and I'm looking forward to the future. With our leverage target in sight and the strength of our balance sheet, our company is operating from a position of financial strength and we have a clear and focused outlook that centers on capital allocation.

Scott Smith
Scott Smith
CEO at Viatris

Turning value to shareholders through dividends and share repurchases will remain a central element of optimizing and maximizing shareholder value. We will balance this with making disciplined investments in regional and global business development to drive our future growth. Thank you all.

Operator

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

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