Viatris - Q1 2023

Transcript

Operator (participant)

Good morning. My name is Gretchen, and I will be your conference operator today. At this time, I would like to welcome everyone to the Viatris 2023 1st quarter earnings call and webcast. All participant lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer period. If you'd like to ask a question at that time, please press star one on your telephone keypad. If you need to ask further questions, you may re-enter the queue. Lastly, if you should require operator assistance, please press star 0. Thank you. I will now turn the call over to Bill Szablewski, Head of Global Capital Markets. Please go ahead.

Bill Szablewski (Head of Capital Markets)

Good morning, everyone. It is my pleasure to welcome you to our first quarter 2023 earnings call. With us today is our CEO, Scott Smith, President Rajiv Malik, CFO Sanjeev Narula, and Jeff Nau from our Eye Care division. 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 forward-looking 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 and the limits applicable to forward-looking statements. We will 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 slide presentation. 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, it is my pleasure to welcome our CEO, Scott Smith.

Scott Smith (CEO)

Good morning, everyone. I'm excited to speak to you today officially as the CEO of Viatris. It's been a busy and productive first month. Viatris is a special company. I knew that from the moment I joined the board in December. I appreciate it even more today. It begins with our ability to sustainably deliver access to high-quality medicines at scale to people, regardless of geography or circumstance. Since becoming CEO, I have met with colleagues all over the globe. I've had the opportunity to spend time with each business segment. I have seen firsthand the unique combination of passion, dedication, and skills of the people of Viatris. Their unwavering commitment to our mission is infectious. I'm honored to be part of this amazing organization. I'm extremely impressed by everything that has been accomplished to date.

In addition to our historically strong regulatory, clinical, and manufacturing capabilities, I've also been very impressed with the company's global commercial infrastructure and the talented people we have there. I look forward to finding additional ways to leverage these capabilities to deliver more access to more medicines to more patients around the world. I want to reiterate that I firmly believe in the strategic plan announced in November of last year. I believe that executing this plan will ensure that we are able to solidify our unique place in the global healthcare landscape. A critical part of my job is to enhance the already strong execution of the company and ideally accelerate our well-crafted strategy. From what I've already seen and experienced, I believe we are positioned well to be set up for success in phase two of our strategic plan.

I believe that Viatris has the strong financial profile and financial flexibility to accelerate growth in the coming years, and I am fully aligned with the future capital allocation priorities that the company laid out in November. Namely that, although we are not giving guidance beyond 2023, beginning in 2024, we expect the reshaped, rebased company to generate at least $2.3 billion of free cash flows per year, excluding transaction costs and taxes. In phase two, we intend to earmark approximately 50% of our free cash flows annually to be returned to shareholders in the form of dividends and share repurchases. With the remaining 50%, we intend to identify and be able to reinvest further in our businesses organically and inorganically with value-creating strategic transactions.

While I will leave the discussion of details of our first quarter results to Rajiv and Sanjeev, I am very pleased to report that Viatris has had a great start to the year with yet another quarter of strong operational performance that gives us further confidence in our ability to return to growth as we enter phase II of our strategic plan in 2024. In the first quarter, we delivered total revenues of $3.73 billion, adjusted EBITDA of $1.34 billion, and free cash flow of $923 million. Based on the strong performance, we are reaffirming our financial guidance for 2023. We are also laser-focused on executing our pipeline, especially our three franchises with the potential to reach $1 billion each in peak sales by 2028: complex injectables, novel and complex products, and eye care.

On our planned divestitures, I think it is important to note that we are in a position of strength. Executing these planned divestitures is a matter of strategic choice, not a necessity, that we believe will accelerate our ability to move up the value chain and lay a solid foundation for our return to growth in phase two. We have been engaged in productive discussions with a number of interested parties to determine the right fit for these well-performing assets. We continue to believe that these divestitures will unlock meaningful value for the company, and we remain on track with our stated goals, including announcing the transactions in 2023. I expect to be able to announce one or more of these transactions early in the second half of the year.

Finally, on business development, the company laid out a strategic vision for business development in the area of ophthalmology, GI, and dermatology. Our acquisitions of Oyster Point and Famy Life Sciences earlier in the year are excellent examples of the execution of that strategy, and I am focused on continuing to look for additional significant transaction in these areas and potentially others should the right opportunities arise. I think my combined experience with big biotech, big pharma, and smaller biotech companies will help us accelerate this vision. In summary, I could not be more energized by my time at the company so far, by the people I've met, and by all that I've experienced. I look forward to the exciting path ahead.

I'll now turn the call over to Rajiv to provide you with an update on our operations and our pipeline and then to Sanjeev, who will give you more detail on our financial results and capital deployment activities. Rajiv?

Rajiv Malik (President)

Thanks, Scott. Good morning, everyone. As Scott mentioned, we had another strong start to the year and a strong quarter of operational performance across various segments as well as product categories. Let me now begin by sharing our commercial segment highlights from the quarter. As I do, I will be making certain comparisons on an operational basis, which excludes the negative impact of foreign currency rates versus the plan that supports our financial guidance as relates to Q1 2022 results, which also excludes the results from the divested biosimilars business from Q1 2022. Our well-balanced business of developed markets, where brands make up close to 60% of our net sales, delivered another strong quarter. Europe performed ahead of our expectations with France and Italy driving the strong performance.

The region grew low single digits in Q1 compared to the prior year on an operational basis, making it our fifth consecutive quarter of year-over-year growth. Our key brands like Amitiza, Creon, and Brufen, as well as our generics portfolio, continued to perform strongly in Q1. Our North America business also performed ahead of expectations driven by better than expected performance in our generics portfolio, including lenalidomide and our injectables portfolio. Our brand business was led by stronger performance of Yupelri. We look forward to launching several new products in North America this year, including Breyna, our generic to Symbicort. We and our partner, Kindeva Drug Delivery, have settled the patent litigation with AstraZeneca and expect to launch the product after expiration of regulatory exclusivity.

We anticipate launching Breyna with 180 days first-to-file generic exclusivity subject to FDA's future determination of the issue if and when another ANDA filer becomes eligible for final approval. For the remainder of the year in developed markets, we expect to meet or exceed our expectations of both North America and Europe. Moving to emerging markets, Korea, Malaysia, Thailand, as well as Middle East delivered strong performance. Lipitor, Norvasc, and Viagra performed better than expected. Generics also performed ahead of expectations driven by solid ARE performance. We remain confident for this segment to deliver mid-single-digit growth for the full year, primarily driven by our brand category of this region. In JANZ, the brand category fell slightly behind expectations, primarily due to customer buying patterns in Japan.

We remain confident in our overall outlook for the year due to the projected strong performance of our generics, including authorized generics, as well as our brands like Creon, Amitiza, and Effexor. Greater China performed better than expected with 5% year-over-year growth on an operational basis. We expect another strong year of operational performance in line with our expectations as we continue to focus on the retail segment and growing the self-pay patient base while navigating the evolving policy environment. I'm also pleased to confirm that we have 10 regulatory submissions under review with the SFDA in China. Moving to eye care. Tyrvaya's launch continued to progress as planned in its first quarter as a part of Viatris. March delivered Tyrvaya's highest launch to date monthly prescriber count and total prescriptions.

Furthermore, we remain excited about Tyrvaya's opportunities ahead, including driving prescriptions from the recent Medicare Part D coverage wins, leveraging the Viatris commercial infrastructure, and launching its first direct-to-consumer marketing campaign in Q4, which together provides confidence in our current full-year outlook for Tyrvaya as well as beyond that. We have made significant progress in stabilizing our base business, which we believe is one of the key elements to the successful execution of our phase two strategy in 2024 and beyond. One of the primary drivers to our expected stabilization is the effective management of our brand portfolio, which forms approximately two-thirds of our overall base. I'm pleased to report that for the last several quarters, our branded business has consistently performed at or above our expectations across the various geographies.

This continued strong performance of our branded category, as well as generics across the segments, combined with our anticipated $500 million+ of new product launches in 2023, gives us tremendous confidence that our base business, excluding the positive impact of our Eye Care Division, will return to growth in the second half of the year versus the prior year. We believe we are headed into the final stages of completing all aspects of our Phase one commitments and will deliver another strong year that we expect will put the company in a very solid position to execute Phase two. Let me now switch to provide noteworthy updates on our pipeline with a focus on the three key buckets we highlighted at the beginning of the year. I will begin with our portfolio of complex injectable products.

We secured the sole first to file position for Wegovy, a weight loss treatment. We can also confirm that we have achieved the sole first to file status for Ozempic eight mg strength. As we have previously disclosed, we have a shared first to file position on the other strengths of Ozempic. We have strengthened this portfolio and submitted our ANDA for Abraxane used in the treatment of breast cancer, as well as advanced our MR-151 product and anticoagulant into its clinical phase of development. Finally, we have also submitted another first to market ANDA to FDA for MR-204, which is indicated for chronic dry eye disease. Within our select novel and complex products pipeline, I'm really excited to announce that we filed our NDA for glatiramer acetate once monthly to FDA.

As we have previously noted, our GA once monthly product has met its primary endpoint of reduction in annual relapse rate in a placebo-controlled phase three study. GA once monthly demonstrated a 30% reduction in ARR compared to placebo. In addition to this, GA once monthly, when compared to placebo, demonstrated clinically relevant superiority on the Expanded Disability Status Scale score that was statistically significant. For meloxicam, we have completed our end of phase II meeting with FDA on May 1st with positive outcomes, and we look forward to initiating our phase three clinical trials in the second half of this year. We are progressing our IND-enabling study for our Botox program and remain on track to making our IND filing this year. Our eye care pipeline is also advancing as planned. We are pleased that we have received positive top-line results for Tyrvaya in China.

We, along with our partner, are now tracking our submission in China to August of this year. Our clinical program for MR-142 for night vision disturbances is progressing well. We also submitted our IND and are Phase III-ready for our MR-148 for dry eye disease. In addition, we aligned with FDA on the phase III study design for our blepharitis program, which will get initiated later this year. We are executing our IND-enabling study for our nerve growth factor product, MR-146, which we hope to progress to treat all stages of neurotrophic keratitis. Before I hand it over to Sanjeev, I want to recognize that our execution has been and continues to be a team effort, and I would like to thank our colleagues around the globe for delivering another strong quarter.

With that, I will now hand the call over to Sanjeev.

Sanjeev Narula (CFO)

Thank you, Rajiv. Good morning, everyone. We're off to a great start to the year and as a team could not be more confident in our strategy to deliver our plan and return the company to growth. As Scott mentioned, 1st quarter was in line or slightly ahead of our expectation. Our business fundamentals are strong, and we are encouraged by continued performance, including the stability of our base business. In the quarter versus prior year, excluding biosimilar, net sales from our Europe emerging market, China businesses grew operationally. New product contributed well. We are looking forward to several exciting launches in the 2nd half of the year. Early in the quarter, we closed the eye care acquisition and our SG&A and R&D expenses for Q1 includes costs associated with the commercial infrastructure and late-stage pipeline of these businesses.

We continue to see benefit from our unique platform and its ability to generate significant cash flow from operations. We feel good about the opportunities ahead that will strengthen our free cash flow generation. Looking at quarter one 2023 highlights, you will see our summarized results versus prior year on a reported basis. It is important to note that for comparison purposes, our reported results for quarter one 2022 included the biosimilar business. Our net sales and adjusted EBITDA walks show sales for the quarter were in line with our expectation. On an operational basis, down slightly versus the prior year. Foreign exchange had a negative impact of approximately 5% on net sales versus the first quarter 2022. The stability of our business was primarily driven by growth in Europe across diverse portfolio, key products in Greater China, and brands in emerging markets.

As mentioned, base business performance was in line with our expectation, and the full year remains on track with the estimate we provided in the February due to ramp of new product and volumes. New product revenues off to a solid start and benefited from sales of additional strength of lenalidomide. Adjusted gross margin of approximately 60% in the quarter exceeded our expectation and was driven by positive portfolio and segment mix, new product launches, the lower impact of inflation on COGS, and the impact of certain positive variances. We reported strong adjusted EBITDA, which included SG&A investment in the eye care franchise and R&D to progress key programs across injectable and complex products. We had another excellent quarter of free cash flow of $923 million. In the quarter, free cash flow conversion continued to improve.

The year-on-year decline was driven by lower adjusted EBITDA, the biosimilar divestiture, and the impact of foreign exchange. In the quarter, we incurred approximately $22 million in transaction costs, primarily relating to eye care acquisitions. We continue to deliver on our capital allocation plan and financial commitment. As a result, we remain in a strong balance sheet position with a low coupon fixed rate capital structure. We are committed to our investment-grade rating. We continue to pay down debt to reach our leverage target of 3x. In the quarter, we paid down approximately $550 million of debt for a total of approximately $6 billion since the beginning of 2021. Additionally, we returned approximately $400 million of capital to our shareholders in the quarter.

Before I discuss the 2023 outlook, although we are not providing guidance beyond 2023, especially given the strong start to this year, I have even more confidence in our Phase II outlook beginning in 2024. This includes the expectation of generating at least $2.3 billion in free cash flow from the rebased business before any associated transaction costs and taxes. Coming back to 2023, we are reaffirming our 2023 guidance ranges. We currently expect full-year revenue, adjusted EBITDA, and free cash flow to be at the midpoint of the ranges. While foreign exchange continues to be dynamic, based on current rates, we have assumed a slight headwind in Q2 and minimal to neutral impact for the full year. A few update on our expected phasing for rest of the year.

We continue to expect total revenue to be higher in the second half due to ramp and launch of new products, including Breyna, our generic version of Symbicort, as well as normal product seasonality, particularly in Europe. We now expect adjusted EBITDA to be evenly weighted between the first half and the second half, driven by two factors. Number one, gross margin stepping down in Q2 and moderating in the second half due to portfolio and segment mix. Expected higher COGS because of inflation and expectation that positive variance in the first quarter will not repeat. Number two, SG&A and R&D spending to step up in Q2 and increase sequentially in the second half. This includes the expected DTC invested in Tyrvaya, as well as increased investment in the eye care pipeline and organic R&D.

We expect cash flow to be lower in subsequent quarters, given the expected increase in capital expenditure, one-time cost, and working capital. Specifically, quarter two and quarter four will be lower due to timing of semiannual interest payments. As a reminder, our adjusted EBITDA and free cash flow guidance exclude any future acquired IPR&D for unsigned deals, and our free cash flow does not include any transaction costs and taxes associated with the planned divestiture or the eye care acquisition. In closing, based on the sound fundamentals of our business, we are well positioned for a strong 2023, and nothing has changed with respect to our phase two outlook beginning in 2024. With that, I'll hand it back to the operator to begin the Q&A.

Operator (participant)

At this time, if you'd like to ask a question, please press star one on your telephone keypad. If you wish to remove yourself from the queue, you may do so by pressing star two. We remind you to please pick up your handset and please limit yourself to 1 question. We'll take our first question from Glen Santangelo from Jefferies.

Glen Santangelo (Managing Director)

Yeah. Hi. Thanks. Scott, I just wanted to start with you. It seems it's been a couple months since you've been on board, and you had a chance to look at everything and, you know, encouragingly, you seem to, you know, agree with the strategic plan or comfortable with everything. Could you maybe revisit what you expect the proceeds to be from the three asset sales coming later this year? You know, I think from memory, you said $5 billion-$6 billion pre-tax and what is that after tax? Then, you know, what's the plan for those proceeds? Will 50% of that be returned to shareholders? Because that would imply a share repurchase that's significantly bigger than the authorization you currently have outstanding.

Any more details around the back half of the year as it relates to that capital deployment would be helpful. Thanks.

Scott Smith (CEO)

Good morning and Glen, thank you very much for the question. You said comfortable with the strategic plan. I think I'm more than comfortable. I'm very, very supportive of the strategic plan. You know, as I came in on the board at the end of the year, one of the things I was most impressed with was the plan and the way forward. I think it's a very, very strong plan. I'm very, very much supportive of it. You asked a question about divestitures as well, and I think it's really important to note that we expect to be, as I said in my prepared remarks, we expect to be in the previously announced ranges for both value and for timing.

As you know, it's really important to note that we don't need to do these divestitures. We have strong financial performance. These are a matter of strategic choice and not of necessity. You know, these are strongly performing assets. There's a lot of interested parties. We're on track to announce all of them, hopefully by 2023. We hope to be able to announce one or more early in the second half. We're very, very pleased where we are from that perspective. Again, it's really important to note that we don't have to do these divestitures in order to execute on our plan. Our plan is strong and, you know, due to the strong operational and financial performance of the company.

Rajiv Malik (President)

Sanjeev, do you want to talk a little bit? No, I think, Scott, you covered everything. I think just two point to kind of just double-click on that. Glen, to your point about the ranges. We talked about in that net proceeds of about $4.9 billion-$6.1 billion, and that was after the taxes, one-time cost and the Oyster Point acquisition at that point. We stayed within the range. The idea that is, that would be the proceeds that would be available for additional debt pay down, buying back shares, and investing in the business per the capital allocation plan that was already laid out.

Operator (participant)

Our next question comes from Chris Schott from J.P. Morgan.

Chris Schott (Managing Director)

Great. Thanks so much. I'm just following up on the divestiture process. It sounds like things are on track. You mentioned this position of strength. I guess to the extent the current rate environment does not result in valuations that are aligned with your targets, can you still kind of push forward with this capital allocation story and, you know, kind of the targeted acquisitions just given the step-up in free cash flow? Would that part of the plan have to change? I know that's not plan A, but just to the extent that, you know, we weren't able to get all these to goal line, kind of, you know, should we think about there being a different outlook or is the outlook pretty much the same regardless? Thank you.

Scott Smith (CEO)

I think it's... Thank you very much for the question, Chris. I think it's very important to note that due to the strong operational financial performance of the company, we can execute on our financial commitments and on the plan without the divestitures. These are really good, well-performing assets. Yes, there's been some deterioration, I believe, in interest rates in the macroeconomic environment, we don't have to go into any sale that we don't think mimics the value that we see in these important assets. You know, again, having said that, there's a lot of interest in these assets, we believe they're gonna move forward.

I believe they're gonna be, by the time we get to the end of this process, I believe they're gonna be in the previously announced range, both for value and for timing. No, they're not necessary for us to be able to execute on the plan.

Operator (participant)

Our next question comes from Jason Gerberry from Bank of America.

Sabin Patel (Product Manager)

Hey, guys. Thanks for taking our questions. This is Sabin Patel on for Jason. First is on your monthly GA for multiple sclerosis. How do you see the market opportunity there given the decreased use of GA overall? Do you believe you can increase the use of GA with the monthly depot? On Tyrvaya, just early impressions, what do you think is needed to drive the launch curve to look like more successful dry eye launch analogs? Thank you.

Rajiv Malik (President)

Thank you, Jason, for your question. You know, first of all, you know, very happy to announce today the submission of this NDA, very important product for us, with our partner, Mapi. I would say, you know, it's not just a compliance play. We have studied this data very carefully over the last couple of months, deep into the previous studies which are available. The significant treatment effect of the depot product in reducing the ARR strengthened by the MRI endpoint supports the use of the GA Depot for the RMS patients. You know, just put your head around, just as against 1 injection per month, 14 injection is what current treatment is and almost 560 milligram drug against the 40 milligram.

Moreover, you know, not only just was the annual relapse rate, but GA Depot significantly reduced the contrast-enhancing lesions by 28%, as well as new or enlarging T2 hyperintense lesions by 17%, and significantly, you know, helped on the EDSS, which is Expanded Disability Status Scale. So I think with all this, we are looking forward to, you know, GA still. This molecule still has a significant market share, and this product will revive. This product will further revive and boost that, you know, acceleration.

Scott Smith (CEO)

To add, Jeff.

Jeff Nau (President of Eye Care Division)

Sorry.

Scott Smith (CEO)

Yeah. On the Tyrvaya side, if we look at Tyrvaya performance in 2022 is predominantly driven by commercial coverage. As we enter into 2023

Jeff Nau (President of Eye Care Division)

We have increased Medicare Part D coverage from single digits now to leaving the quarter about 54% of Medicare Part D cover lives being covered. If you think about the marketplace, approximately half of all dry eye disease prescriptions come from Medicare Part D. We expect that to be a significant tailwind. As we exited the quarter in March, we had the strongest launch to date for prescribers and prescriptions. We expect this to continue as digital advertising ramps, we initiate the DTC campaign in the end of the year. Furthermore, when we leverage Viatris' commercial infrastructure, we feel that's going to drive an additional intermediate and long-term tailwind for Tyrvaya and the overall portfolio.

Scott Smith (CEO)

I'd just like to make a quick comment on Tyrvaya and the eye care business as well. You know, we need to remember that this deal closed in January, so this Q2 is our first full quarter with Oyster Point under the Viatris tent. Both revenue and demand for Tyrvaya were in line with our expectations for Q1, and March had the highest demand as previously noted. We see opportunities for leverage, strong parts of the existing organization, including commercial access and our large development team to help accelerate revenues in the future, including initiating DTC later in this year. I just want to say that, you know, we're very, very excited about not only Tyrvaya, but the eye care business in general.

Operator (participant)

Our next question comes from Balaji Prasad from Barclays.

Balaji Prasad (Director)

Hi, good morning, everyone. Thanks for the questions. Scott, just a couple of questions on the EBITDA side. You called out $2.3 billion of EBITDA for 2024, at least. Can you help us understand what this factors? I would imagine this factors your asset divestments, and maybe some helpful color would be on what is it like for like. Continuing on EBITDA, the cadence implies that Q2 EBITDA is below where the street is currently. Was there any pull-forward of EBITDA from Q2 to Q1? Thanks.

Scott Smith (CEO)

Yes, I did confirm $2.3 billion going forward, but let me kick it to Sanjeev to get into some of the more context around your EBITDA question.

Sanjeev Narula (CFO)

Yes.

Yeah. Yeah. Thank you, Balaji. I will cover both points that you talked about in terms of 2024. Simple way to think about this is the two, what Scott mentioned, minimum $2.3 billion free cash flow for 2024 is after taking out all the divested assets that we have announced. If you talk about today's 2023 guidance that we have, the $2.5 billion, that includes all the divested assets that we have with us. This is to kind of show you the starting point for phase two, which is assuming all the divested assets are out of the numbers, and that's how you get to that $2.3 billion.

Important to note that before any cost for divestments or any taxes, which will obviously be funded through the divestment proceeds on that. We are well on track, and we feel very good about where we are on that particular point. As far as the EBITDA is concerned, again, we had a strong quarter, came in at our expectations, slightly ahead of our expectations. The way to think about EBITDA in terms of the phasing is going to be now evenly phased between first half and second half. That's going on because of there are two factors that is driving it. First is obviously the gross margin, which, you know, first quarter came in ahead of our expectation.

Our gross margin is going to step down in Q2, and then go to moderate in the second half of the year. There's a function of product and portfolio mix, the continued impact of the inflation and non-repeat of certain positive variances that we had in the first quarter. Then you obviously have the SG in R&D stepping up, starting from Q2 and late in the year because the investment that we are making in the eye care division, the R&D pipeline on organic products and the DTC that Scott talked about for Tyrvaya, which is going to kick in at the later part of the year. That's why we feel again great about overall where we are, but that's the cadence that we expect now, but still will be at the midpoint of our EBITDA guidance.

Operator (participant)

Our next question comes from David Amsellem from Piper Sandler.

David Amsellem (Managing Director and Senior Research Analyst)

Thanks. Just wanted to ask a couple of product-specific questions. You still have a lot of exposure to Lipitor and Norvasc. Can you talk about how sticky you think those products can be globally? Then secondly, just in general, how are you thinking about the trajectory of the established brands portfolio over time? Then another question I have is just, this is a high-level philosophical question. As you think about your exposure to regular way generics, oral solid generics, in developed markets in particular, you know, how do you think about the role of that business in the overall organization? I guess more specifically is, you know, are oral solid generics a business that you want to de-emphasize over time? Thank you.

Rajiv Malik (President)

I can start from the second part. I think we never weren't deemphasizing the oral solid business. All we did was diligently looked into our portfolio, looked into where there are multiple options, products are commoditized. There are more than 10, 15 suppliers out there. Access is not an issue. We pruned that portfolio and focused on going up the value chain, focused on access of the more complex, hard-to-make products, because somebody's going to take the lead to bring those products to. I would say that generics are still a very important part of access. Basically, it's all about access, and that's where we have been focusing on bringing access to these hard to make difficult products in this segment across the globe. We're not walking away from that segment. That's the first thing.

Second, from the brand's point of view, established brand's point of view, not just Lipitor and this. You know, these brands, some of these brands were before Upjohn or even the Abbott experience. They were, you know, declining at an accelerated rate. We... Why? Because there was perhaps not enough focus over the last two years. We have... I know what we have to work with, and we are focused on these products. Over last several quarters, six to eight quarters, we have been able to stabilize this bucket very successfully from, you know, initial decline of 4% or 5% to about 1%, now 1%. In fact, this quarter it was flat. Next quarter you will see this segment coming to a little bit of growth.

It's all about stabilization of this bucket, which is leading to the further robustness of this platform. We are very excited with the, you know, work which we have done around this and our ability to manage this portfolio.

Operator (participant)

Our next question comes from Ash Verma from UBS.

Ash Verma (Executive Director of SMID Biotech & Biopharma)

Hi, thanks for taking our questions. I have two on pipeline. One on Botox. Have you received clarity from the FDA? Can you share with us, like, what's gonna be the trial design by similarity, endpoint, et cetera, for this program? Are you pursuing just the therapeutic indications here and not aesthetics? Separately for Xulane low dose, can you elaborate a little bit like what is the value proposition? Does this in any way expand the market opportunity, or is it going to cannibalize the high dose product that you have? Thanks.

Rajiv Malik (President)

You know, on Xulane low dose, Ash, market is already like a commoditized cannibalized. I would not say it's cannibalized, but commoditized with now one, two, three players out there. Xulane low dose actually is a medical need. It's a, you know, unmet need over there. There's been always an ask for a low dose, you know, hormonal product over here. We are well on track. We are phase I studies are now completed, sensitization, irritation, adhesion, and phase III study is underway, targeting about 1,200 women. We are looking forward to bring this product to the market maybe by 2025, 2026... Sorry, 2026 in this case. On as well as the Botox, yes, very early on, maybe almost a year and a half back, we sought the alignment, and we got the alignment with the FDA.

Very clearly what their expectations were on CMC and what on the clinical trials. Like, for example, one of the clinical study, they were looking on a cervical dystonia as well as extensor digitorum brevis. All those studies are well in, you know, all that work is well on track, and we will be submitting our IND later this year for the initiation of phase three studies.

Operator (participant)

Our next question comes from Umer Raffat from Evercore.

Umer Raffat (Senior Managing Director and Senior Analyst of Equity Research)

Hi, guys. Thanks for taking my question. I have two here, if I may. First, it seems like China's been a very good tailwind through the duration of COVID lockdowns. Considering it did so well last year, considering it's doing so well, up 5% in 1Q as well, how are you baking in potential for a restart and implementation of VBP programs across China into back half of this year and especially into next year? Number one. Number two, Symbicort. I know Advair opportunity did not necessarily play out versus your internal expectations, and it perhaps wasn't really a needle mover. In fact, one of the big droppers this quarter is your Wixela product. Why should Symbicort be different? To what extent has the brand discounted on Symbicort already? Thank you very much.

Rajiv Malik (President)

Thanks for the question. Wixela is and Wixela always has been, ever since launch, a very meaningful contributor. Even this quarter, it has been a very decent contributor to our projection or to our numbers and all that. It's a very important product. You know, we have met and exceeded every expectation we had around Wixela, and we expect to leverage what we learned in the market to further leverage the same expertise to leverage in this product. We are very much looking forward to bring this product once the regulatory exclusivity expires, everything is lined up. We anticipate launching this with the 180 day first of file generic exclusivity, unless, as we mentioned, subject to FDA's future determination of this issue when another ANDA filer becomes eligible for final approval. Now let me switch back to China.

4 years of successful implementation of VBP, China has significantly improved the cost efficiency. First, I will tell you, we don't have any more products to go through the VBP rounds at this point of time. We have gone multiple rounds. The market has evolved towards segmentation of privately paid and government reimbursement paid. What have we done at our end? Commercially, we have aligned, we have continued to make a lot of progress effectively to compete in, especially in the, you know, private paid channel, leverage the brand equity of the products in the private paid channel and reorient ourselves over there. Operationally, what we have done is loaded up the pipeline. We have already 10 products under, you know, active review with the FDA. Sooner than later, this pipeline will start coming up into the add to the growth.

On my last one, I was just there with our management team, as Scott in China to review. I'll tell you, we had a great team. They have been pro-performingly wonderful well during whether the COVID or even during the integration. This was the first time we ended up there after integration. I have nothing to say but the great things, our confidence in that business has been, you know, reconfirmed. Scott, you would like to add something?

Scott Smith (CEO)

Yeah. And just, thank you for the question, and just add to what Rajiv said there. My first international trip on behalf of Viatris was to China and to meet the China team, and I was incredibly impressed by the leadership, by the strength of the leadership team, and the overall strength of the operating affiliate in China. A very strong, particularly commercial organization that we have there. You know, as Rajiv noted, lots of products in the pipeline and really looking forward to the next step with our affiliate in China.

Operator (participant)

Our last question comes from Nathan Rich from Goldman Sachs.

Nathan Rich (Equity Research Analyst)

Great. Thanks for the questions. One high level and then one on the quarter. I guess, Scott, you know, how are you thinking about the best way to prioritize the free cash flow that you're planning to reinvest in the business, either organically or to drive growth inorganically? Any thoughts on therapeutic areas that you think the company should focus on? Then on the quarter, the level of base business erosion was a little bit high relative to the full year guidance. I think complex generics were called out as a soft spot. I guess, could you maybe just talk about how this is expected to trend over the balance of the year? Thank you.

Scott Smith (CEO)

Thank you for the questions. Just relative to the Viatris strategy going forward, you know, what was laid out in November, the areas we were going to focus on were GI, dermatology, and of course, eye care. I am very, very comfortable in all those areas. I've had very significant experience, both development experience and commercialization experience in GI and dermatology, and again, very comfortable moving forward in those areas. I will say, however, though, we will also be opportunistic. If there's something, and we're very open to something outside of these areas, if it fits our business dynamic and is right and will bring the right kind of value to the company. You know, I'm very excited about the strategy going forward. Again, focus, eye care, derm, GI, but opportunistic and open to other opportunities as they come in.

I think if you take a look at the model of the type of acquisitions that we would like to make, take a look at the Oyster Point and Famy Life Sciences that was completed earlier in the year. It's an excellent example of the execution of that strategy. We acquired a company with an approved asset, customer-facing organization, and we were able to marry it with the Famy development assets. I think that's a really good example of the type of deals that we'd like to do going forward.

Rajiv Malik (President)

Yeah. Nate, on the, you know, erosion, everything as we had expected, everything as per expected, it came from the complex generic category, as you noted, largely driven by three products in the North America. one was Restasis, because we had almost exclusivity of Restasis over last year, over this period. We had an initial competition come on Xulane, Amneal, that's first second contributor. The third was with Wixela, where we have seen some hyper competition over there. I think these three products largely contributed to the erosion in the North America in the complex generic category. As we look forward, I think, we're looking forward to, in fact, bringing developed markets back to the growth in the second half of the year.

Scott Smith (CEO)

Okay, guys. I believe that was the last question or the end of the questions. If so, I'd just like to take a moment to say thank you to everybody on the call for your time and attention today. Just wanna say, really proud of the strong operational and financial quarter we had in Q1, a great start to the year, and I really look forward to meeting and spending more time with all of you as we move forward in the future here. Thank you very much.

Operator (participant)

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