11/7/2024

speaker
Operator
Conference Call Operator

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. 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 the most directly comparable gap 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 2024 and 2023 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. With that, I'll hand the call over to our CEO, Scott Smith.

speaker
Scott Smith
Chief Executive Officer

Good morning, everyone, and welcome to our third quarter 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 sixth 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. The interest is not only stronger and more streamlined, but more importantly, our future direction is now clearer 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 third quarter, we delivered total revenues of $3.8 billion, which represents operational revenue growth of approximately 3%, adjusted EBITDA of $1.3 billion, growing approximately 4% from a year ago, and adjusted EPS of 75 cents per share, growing approximately 6%. We had a very strong quarter of free cash flow, generating $866 million, excluding the impact of transaction costs and taxes. New product revenues were also strong at $133 million in the quarter. We delivered on our commitment to use the proceeds from our divestitures to pay down debt repaying approximately $1.9 billion 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. 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&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 Sotovaclozin in all markets outside of the US and Europe. With this licensing agreement, we are continuing to build on our strong presence in cardiovascular disease, which already includes approximately $2.5 billion in annual revenue, as well as Saladagrel, which we licensed earlier this year. 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 and our infrastructure to execute on the potential of soda. This quarter is a great demonstration of the power of a stronger, more streamlined Vietris. 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. Now I'd like to turn the call over to Philippe to share an update on our pipeline. Philippe?

speaker
Philippe
Vice President of Research and Development

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. 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 lifecycle 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. TETs like cetagliflozin 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 M-PESA 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-US markets and conduct clinical studies where needed to expand patient's reach. We also believe there is a potential for expansion into further indications, which could include hypertrophic cardiac myopathy. Further, Viatris 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 Arixtra and Fraxiparin. With this legacy and broad portfolio also comes very strong relationship with the medical community, which we're tapping into as we progress our Ciladogrel program. I've provided details about Ciladogrel and Cinerimod on our last call, but let me share a brief status update. Our recruitment efforts 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 scenario modifications by initiating a registration program in Lucas Nephritis. And finally, as part of our innovative pipeline, we are continuing to advance our ophthalmology program with three key registrational readouts expected in 2025. I'm proud of the work to date across our entire R&D platform. and believe will continue to make an impact for many years to come by harnessing the combination of both our base business and innovative pipeline. And with that, I'll turn it over to Dorena.

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