Hello. My name is Travis, and I will be your conference operator today. At this time, I would like to welcome everyone to the Viatris 2023 Third Quarter Earnings Call and Webcast. All participant lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer period. I will now turn the call over to Bill Szablewski, Head of Global Capital Markets. Please go ahead, sir.

Good evening, everyone. Welcome to our third quarter 2023 earnings call. With us today is our CEO, Scott Smith; President, Rajiv Malik; and CFO, Sanjeev Narula. During today's call, we will be making forward-looking statements on a number of matters, including our financial guidance for 2023 and various strategic initiatives. These statements are subject to risks and uncertainties that could cause future results or events to differ materially from today's projections. Please refer to today's slide presentation and our SEC filings for a fuller explanation of those risks and uncertainties. We will also be referring to certain actual and projected non-GAAP financial measures to supplement investors' understanding and assessment of our financial performance. Reconciliations of those non-GAAP measures to the most directly comparable GAAP measures are available on our website and in the appendix of today's discussion. We will be making certain comparisons of results on an operational basis, which excludes the impact of foreign currency rates versus the plan that supports our prior period results, which also exclude the results from the divested biosimilar business. An archived copy of today's presentation and other earnings materials will be available on our website at investor.viatris.com following the conclusion of today's call. With that, I'll hand the call over to our CEO, Scott Smith.

Good afternoon. I'm pleased to report that Viatris had another outstanding quarter in Q3. We achieved our second consecutive quarter of year-over-year operational revenue growth and our 11th quarter of positive operating results and consistent operational metrics. All are evidence that we continue to build momentum as we bring Phase 1 of our strategic plan to successful completion. In the third quarter, we delivered total revenues of $3.94 billion, representing approximately 1% year-over-year growth, and adjusted EBITDA of $1.36 billion and free cash flow of $738 million, both of which, as you will hear more about from Sanjeev later, were above our expectations. Based on our strong operational performance in the first nine months of the year, we are reaffirming our 2023 financial guidance ranges for adjusted EBITDA and free cash flow. The Company is delivering strong operational revenues in line with our expectations. However, the impact of foreign exchange headwinds requires that we make a modest adjustment to our 2023 total revenue guidance range due solely to these FX headwinds. In addition, at the end of the third quarter, we were pleased to announce that we entered into agreements on all our planned divestitures. Announcing these transactions marked the achievement of an important milestone in the execution of our Phase 1 strategic plan. We ran a strong and competitive process, and we were able to sign agreements to divest substantially all of our over-the-counter business, our women's healthcare business, our API business in India, and commercialization rights in certain non-core markets that were acquired as part of the Upjohn transaction, all within our previously announced timelines and valuation ranges. We anticipate closing all these transactions by the end of the first half of 2024. As we look to 2024 and beyond, the momentum we see in the business gives us continued confidence that we are on track to meet our previously stated long-term goals. Specifically, we believe our existing business is well-positioned. We continue to believe that adding new avenues for growth to the stable base business will help ensure that we reach our goal of accelerating growth in the future. As we move into 2024, we remain confident that with the proceeds from our planned divestitures and our ability to generate at least $2.3 billion in free cash flow per year, excluding transaction costs and taxes, we have a clear line of sight to hitting our leverage target ratio of 3 times, while also returning capital to shareholders through dividends and share buybacks and investing significantly to accelerate the growth of our business. We believe our focus on returning capital to shareholders and on investing in our business will be important levers to put the company on the path to achieve our long-term goals of revenue and earnings per share growth, two measures that we believe will be critical to valuing our company in the future. We plan to make investments both in our base business and in business development activities that give us the greatest potential for growth, patient impact, and shareholder value. From a business development perspective, I am optimistic that we will be able to execute high-quality agreements that will capitalize on the strength of our global platform. We are focusing our efforts on M&A, strategic licensing, and partnerships. We are looking for innovative high-growth assets focused on areas of unmet medical need that align with our vision of addressing global healthcare needs and bringing access to high-quality medicines to more patients worldwide. Before I turn the call over to Rajiv to provide you with an update on our operations and our pipeline, I want to acknowledge the recent announcement that Rajiv will be retiring as an Executive of the company next April. It has been a privilege to get to know and to work with Rajiv during this past year. I could not have asked for a better partner during my onboarding at the company. I wish him nothing but the best in his eventual retirement, and I look forward to working closely together in the months ahead as we complete our planned divestitures and prepare the organization for the future. And to his continued partnership as a member of the Board of Directors.

Thanks, Scott. I appreciate it and look forward to working with you to ensure a smooth transition while continuing to support you as we look out into the future, but in a different capacity. I also want to take the opportunity to thank all of our employees who have helped us build this strong global platform. I'm very pleased with where we are today in Viatris’ journey and the strength as well as stability of our core business, which is now nicely set up for the continued growth from here onwards. Moving to our Commercial segment results. We have delivered a second consecutive quarter of year-over-year operational top line growth as we predicted, which further reaffirms that we are standing strong and set up for the future. This quarter, we recorded 1% year-over-year operational growth and are well-positioned to end the full year in line with our expectations. Our well-balanced business of developed markets delivered another strong quarter growing 2% year-over-year operationally. Europe grew 1% versus the prior year on an operational basis, making it the seventh consecutive quarter of year-over-year growth. France and Italy led the growth in the region. A solid performance of generics in Europe was another contributing factor. Our North America business was up 4% year-over-year on an operational basis, in line with our expectations. Our generics portfolio performed better than expected, driven by new launches such as Breyna, the generic for Symbicort, Lisdexamfetamine, and the continued contribution of lenalidomide. Also, some other key products, including glatiramer acetate, vancomycin, and Xulane performed better than expectations. Our brand business was supported by strong demand in YUPELRI, which grew 9% this quarter over last year and in the epinephrine market. Overall, we remain confident that the developed market segment will meet our full year expectations. Emerging markets had another strong quarter and delivered 2% year-over-year operational growth, led by strength across our broader generics portfolio and stronger-than-expected performance from brands like Lyrica, Zoloft, and Effexor. Emerging Asia and Turkey were solid-performing geographies. This segment is well-positioned to deliver mid-single-digit year-over-year growth. Moving to JANZ, where brands performed in line with our expectations, while generics were slightly below expectations primarily due to customer buying patterns. We continue to be on track to deliver full year expectations. Greater China experienced another solid quarter, primarily driven by strong performance of the retail channel in China. Greater China was flat to the prior year, in line with our expectations. We believe that this segment will perform slightly better than our expectations for the full year. I'm also happy to report steady progress we made on our pipeline in this region. We recently received positive top-line results for our Phase III clinical trials of YUPELRI in China, which is consistent with our U.S. clinical data, and we look forward to submitting our NDA mid-'24. We currently have 10 other products under health authority review in China. Moving to the Eye Care division. As a bridge program sunsets, we saw almost 9% non-bridge prescription growth in this quarter. We'll continue to focus on prescription growth in Q4 and into the future, supported by our first direct-to-consumer marketing campaign for Tyrvaya, which we launched in early October. We have recorded $345 million in new product revenue year-to-date and are on track to deliver more than $450 million of revenue from new product launches for the full year. Let me now discuss some key updates for our R&D pipeline. We are excited by the continued progress of our eye care pipeline, which is aimed at addressing a range of vision-related disorders. All the Eye Care development programs remain on track, and we are pleased that we received FDA approval for Ryzumvi for the reversal of pharmacologically induced mydriasis and are looking forward to a commercial launch in the U.S. in the first half of '24. Switching to other pipeline updates, beginning with Glatiramer Acetate. As you recall, the FDA had accepted for review our NDA and it assigned a PDUFA date of March 8, 2024. While we continue to make steady progress regarding the FDA review of our NDA, we are saddened by the tragic situation in Israel and we are working very closely with our partner, Mapi, who remains fully operational. We have recently submitted our registration in Europe and are excited about the potential opportunity to bring this product to patients in Europe. Our Botox biosimilar program is progressing well in terms of development, characterization, and validation of drug substance and drug product prospective. We recently completed the manufacturing of our IND-enabling drug substance batches and are well on our way to complete the drug product contracting. We remain on track to file our IND by the end of this year. We expect to initiate the pivotal clinical studies for this program in the first half of 2024. Our Phase III study for our Xulane Low Dose program in the U.S. remains on track, and we have benefited from an acceleration in the enrollment rate for this study. We now expect to enroll our last patient this December. Additionally, we are closely interacting with the FDA to initiate the Phase III program for our Opioid Sparing Meloxicam novel product in late December. Our Phase III study for Effexor generalized anxiety disorder in Japan continues to progress according to our schedule, and we remain on target to submit the NDA filing in the first half of 2025. Finally, all of our complex injectable programs are moving ahead as planned, and we continue to be very excited about the potential of this important potential $1 billion franchise.

Thank you, and hello, everyone. Before I begin, I would also like to extend my congratulations to Rajiv. It has been a great partnership over the past three years, and I am proud of what we've accomplished together. We trust our colleagues and patients all over the world to benefit from your leadership, expertise, and dedication to our business. Turning to our outlook, I want to reiterate my confidence in the strength of our unique global platform in the continued durability of our significant free cash flow generation. We're pleased with the outcome of our announced divestiture, which, upon closing, will bring the successful conclusion to our Phase 1 commitments and further serves to accelerate our financial flexibility. As we work to finalize the plan for next year, and although we are not providing guidance at this time, we continue to expect at least $2.3 billion in free cash flow in 2024 even when taking into consideration inflation and foreign exchange headwinds to date. This excludes any taxes and transaction costs associated with divestiture. For the second consecutive quarter, the business delivered total operational revenue growth versus prior year. The performance was diversified across regions and categories. The positive mix of brand and new products drove strong gross margins. From a regional perspective, we saw 2% growth in net sales from developed and emerging markets. The growth included the benefit from brands, generics, and new launches. Net sales for the quarter were in line with the expectations and grew 1% versus the prior year. A diverse portfolio of growth drivers included brand performance in emerging markets, Europe, and Greater China. These revenue trends and positive momentum are expected to continue as we exit the year driven by brand strength of our global generic portfolio and new products. New product revenue in the quarter met expectations and included the first quarter of Breyna. Adjusted gross margin was approximately 59% in the quarter and was ahead of our expectations. We continue to see the positive impact from portfolio decisions driving favorable mix. We reported strong adjusted EBITDA, which included investment in SG&A and R&D to advance key programs across eye care, injectable, and complex products. As a result of strong adjusted EBITDA and improved cash conversion, we had an excellent quarter of free cash flow of $786 million excluding the impact of transaction costs, which represents growth of 3% on a reported year-on-year basis. We have generated over $7.2 billion of free cash flow over the last 11 quarters, and as a result, we have been able to pay down approximately $6.1 billion of debt during the same period, and we will pay down the $500 million maturity in Q4 from cash on hand. Additionally, this quarter, we returned approximately $144 million of capital to our shareholders. We expect to absorb this potential FX impact and still cash flow. Now a few updates: We continue to expect adjusted EBITDA to be lower in Q4 than prior quarters driven by two factors. First, low gross margin due to less favorable portfolio and segment mix. Second, SG&A is expected to increase as a result of investment in the Tyrvaya direct-to-consumer campaign and other areas to drive future growth. We anticipate free cash flow in Q4 to be impacted by lower adjusted EBITDA, higher capital expenditure, and timing of biannual interest payments. As a reminder, our free cash flow guidance does not include any transaction costs and taxes associated with biosimilar divestments, the Eye Care acquisition, or the planned divestiture. Additionally, our adjusted EBITDA and free cash flow guidance excludes any acquired IP R&D for unsigned deals. In closing, based on the continued strong underlying fundamentals of our business, we're well-positioned for the remainder of the year, and the outlook for 2024 continues to be positive.

Great. Here was on how envisioning kind of capital deployment and specific verticals that you talked about in the past. I'm trying to get my hands around. Is this something that you’re kind of actively looking at this point? Or do we need to wait for the transactions to close and the sense of being more of a 2025 and beyond kind of event that we think about kind of the redeployment of some of the cash coming in the door? Or just any color you can provide there would be much appreciated?

Thank you, Chris, for the question. Yes, we're looking for innovative high-growth assets that bring in predictable, durable revenue streams and are a good fit for our business that we can leverage the strong global infrastructure we have. You asked about the verticals; we're definitely looking at things in those areas. We're also going to be a little bit agnostic, and if there's a good opportunity that lies outside of those verticals, we will look at that very closely as well. The important thing for me is whatever we do, we want to leverage the global strength that we have as a company. In terms of business development, I look at it in sort of three buckets: M&A, of course, but also licensing is very important and partnership is very important. Some of them are more capital-intensive than others. And in terms of speculating on timing, I won't speculate on timing at this point. I think we're looking at things very actively right now, and we'll see where we get. But we're excited about the opportunities that are out there. I think there's a lot of opportunities where we're going and what we're doing. So I appreciate the question.

Great. Good afternoon, and thanks for the question. I wanted to ask about the kind of transition to Phase II. You gave some details around the 2022 EBITDA of the announced divestitures. Now I know you don't want to give EBITDA guidance for 2024. But any color you can provide on how those businesses have trended over the past year? And any other considerations from a cost standpoint that we should think about? As we think about the transformation of the business and the acceleration of top line growth, can you help us walk through what the building blocks are to eventually getting the business to that kind of 3% revenue CAGR that you're targeting in Phase II?

Yes. So first of all, yes, to '24, I feel great about where we're going in '24. We've had now two consecutive quarters of operational growth, and we believe we'll finish '23 strong. I think it will set us up very nicely for '24. We have full confidence that we're on track to meet our previously stated long-term goals. I guess really importantly, we expect to have at least $2.3 billion in free cash flow in '24 and beyond. Even when you take into consideration inflation, FX headwinds, etc. I think there's a very strong base to the business, and we expect to grow just with the base business, as you mentioned, in that 3% range. Just off of the base, the business that we have a stable, growing, strong globally right now. But we hope to even achieve a significantly higher growth rate than that from a revenue perspective as we start to invest in business development and other businesses and bring other assets in that can complement the organization that we have in place. And Rajiv, I think there was a question around divestiture.

Yes. No, that was a specific question, Nathan. Can you speak on divestiture?

First of all, from the overall business point of view as well as between the two divestitures, all our businesses are performing as we anticipated or better than we had anticipated, including whether it's geography or whether it's the brands, generics, and those categories. And that holds basically true for also the businesses which we have identified and which are going through the divestiture. But also, Scott, to your point, the 3% growth which we have indicated, just to add on to that, includes our base business, what we have in the pipeline today; that didn't include any more deployment of the capital which may come from '24 onwards, that will be on top of that. So I just wanted to build upon that.

I also want to piggyback off what Rajiv said. As we start to pivot to real growth from a revenue perspective and given our capital allocation plan and our desire to buy back shares, we can move the story to a long-term adjusted EPS growth story, which we're very excited to transition into in the early part.

Hi, guys. Thanks for taking my question. I wanted to focus on the China business for a second. It looks like your China business is holding in broadly fairly stable, except for FX. It appears to be quite different in performance versus what some of your peer companies also with meaningful China businesses have reported. I see that not just in the emerging markets sales reported but also in the product level breakout. I'm just curious, what do you think is tracking different, or is there some timing of revenue recognition that is playing out and maybe we do see some weakness in 4Q? Because it seems like it's a little more industry-wide?

Umer, I can't speak about our peers; I can speak about our China business. Right from ever since we have gone through this evolution around the policy dynamics and all that live through; our 95% business has gone through the VBP. We had gone through the cycles of VBP. We have taken this time to reorient and shift our business more towards a private paid channel. That's what we have seen. We have found that the equilibrium between the hospital and private pay channel, and we have been trying to invest more in that. Investing in the pipeline, for example, even this quarter, just getting the Yupelri positive data because Yupelri and Dymista performance are now going through the approval channels. We cannot be more excited about what we are seeing in the underlying business or the fundamentals of our China business. Extending that to emerging markets, we took our time to figure out how to manage this hybrid business we have between the brand and the generics, and we have found that sweet spot, and you see the emerging markets business; the brand is performing better than expected, and generics are performing better than expected. I can only speak about our business, and we seem very confident and optimistic about this business, and that's what is driving the stability to the base. Coupled with the new launches and new launch revenue, I think that's what is driving the based growth of 1% year-over-year, which you see in that.

Thanks for taking my question. I just wanted to follow up, Rajiv, on some of the comments you were just talking about: that the generics business was performing better than expected. Could you maybe talk about the pricing environment in terms of what you saw in the quarter? And if there's any discernible trends that are worth sort of calling out? Any comments around the sustainability of that recent trend would be helpful.

Glen, after several quarters, I can say that we have seen perhaps a longer stretch of stability after so many years, I would say. I don't see any trend at the moment because it's a generic business that plans for both demand and supply. At this point in time, we still see some supply disruptions going on with some key molecules and key products. It’s about your own portfolio, your own ability to supply, and basically the flexibility in the supply to sometimes respond to the market needs. That's what I think we have set for ourselves, and that's providing us stability. I don't see at the moment in the environment any more trends which we should be concerned about.

Thanks for taking my question. Just wanted to inquire about the inflationary pressures on the cost of goods that was flagged last quarter. It appears like either that was maybe not realized this quarter because of mix or perhaps there were some other offsets. Really curious more so just to think about how those inflationary pressures, do you feel like you may see those manifest in Q4 or into next year?

Yes. So Jason, thank you for the question. We had anticipated inflation pressures, and we've talked about that when we made our plan and guidance for that. We're managing our costs very well. So the impact is still there for inflation, and in this quarter, we have an inflation impact, but it is less than what we had anticipated. Clearly, our teams are doing a great job in managing the cost, and you can see that reflected in our gross margin, which is coming in better than we expected. We've actually raised the full year metrics to 58.75% on the strength of mix and us managing the cost, including inflation, better than what we had anticipated.

Thanks for taking my question. So on emerging markets, can you elaborate on the dynamic here a little bit? You mentioned customer buying patterns impacting Q3? I didn't hear you saying that you're going to expect to get to the outlook that you had for the emerging market, although I heard that for other geographies? And second one, I just wanted to understand the FX impact. So Q3 revenue saw a $7 million headwind, but you're lowering your 2023 midpoint by $250 million. Is this all concentrated in just Q4 alone?

I think on emerging markets, some of our key brands, Lyrica, Zoloft, and Effexor region, some of the brands have been performing pretty well. Turkey and also emerging Asia, we call it, which includes geographies like Thailand and other countries, have performed above expectations. I see this trend continuing as I see emerging markets well on track for mid-single-digit year-over-year growth driven by the strength of their portfolio, diversity, and markets that we are seeing that confidence.

So, Ash, on the FX, a couple of comments. We have 70% of our business that is non-U.S. dollar denominated. Fifty percent comes from three currencies: the euro, Japanese yen, and Chinese RMB. What was going on until about September, as you could probably track that. The dollar had strengthened against the Chinese RMB and Japanese yen. The euro was favorable to what we had assumed. But September onwards, the euro started weakening with all the Fed actions that were going on. So whatever the offset that we were seeing in the first half of the year went away. You see the impact is much bigger now starting in September in Q4 than we had anticipated, and that's what we are reflecting in our full year guidance, assuming the October 8 standings. So it's all three currencies and all FX, and operationally it is exactly in line with what we had anticipated. We reaffirmed our guidance on EBITDA and free cash flow, absorbing the FX impact.

So this is Brian Roman, the General Counsel. Thanks for the question. Our company has been an industry leader in challenging improper Orange Book listings for many years. This is an issue that we understand well, take seriously, and frankly, I like to see the issue getting some attention. The FTC hasn't shared with us what concern they have about these particular patents. But I'd add that there has been significant generic competition for our epinephrine auto-injectors for years.

So just a couple of product-specific questions. Can you talk about how you're thinking about the generic Symbicort contribution next year? I know you talked about revenue being below expectations and developed markets because of phasing of that product. So just talk about where that product is heading. Then any update on iron sucrose that would be helpful. And then on business development, what's your willingness to move away from that or look at other therapeutic silos?

So I'll answer the last part of the question first. As I said earlier, those three verticals, we think very highly of in terms of the type of assets that are there. We'll keep our minds open. There are assets outside of those three areas that we find can really help us secure our growth in Phase II, and we'll definitely look at them. Regarding the launch of Breyna generic with the Symbicort, we couldn't be more pleased to launch another complex product to make products as an affordable alternative. We are looking at the pickup of market share. Now it isn't captured for customers, as we can sell to some common entities, veterans, or patients. It doesn't capture. We're exactly how we are modeling. It's going to be a significant contributor because we don't see competition on the horizon at this point for the next year. It's going to be a meaningful contributor. We are very happy to have more than $450 million, and we have already captured $345 million on new launches, and we are on track to do more than $450. Most likely, the launch will be early in the first quarter of next year, and nothing has changed; otherwise, we are exactly on track.

Are there any more questions in line?

No sir. I would now like to turn the call back over to Scott Smith, CEO, to make a few closing remarks.

Thank you very much, and thank you to everybody on the call. In summary, I'm very pleased with the overall execution momentum and the momentum that we have as we bring Phase 1 of our strategic plan to a successful conclusion. I'm very much looking forward to moving into Phase II of our strategic plan, and I fully believe in the future trajectory of Viatris, and I'm very excited for what's to come. Thank you all again for your attention.

This does conclude today's Viatris 2023 third quarter earnings call and webcast. Please disconnect your line at this time and have a wonderful day.