Viatris Inc (VTRS) 2021 Q2 法說會逐字稿

Good morning. My name is Christie, and I will be your conference operator today. At this time, I would like to welcome everyone to the Viatris 2021 Second Quarter Earnings Call and Webcast. (Operator Instructions) Thank you.

I will now turn the call over to Melissa Trombetta, Head of Global Investor Relations. Please go ahead.

Thank you, operator. Good morning, everyone. Welcome to Viatris' Second Quarter 2021 Earnings Conference Call. Joining me on this call are Viatris' Chief Executive Officer, Michael Goettler, President, Rajiv Malik; Chief Financial Officer, Sanjeev Narula; Chief Accounting Officer and Controller, Paul Campbell; and Head of Capital Markets, Bill Szablewski. While some of us are in remote locations, I would ask for your patience, should we encounter any technical difficulties.

During today's call, we will be making forward-looking statements on a number of matters, including our financial guidance for 2021. 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 the earnings release that we furnished to the SEC on Form 8-K earlier today for a fuller explanation of those risks and uncertainties and the limits applicable to forward-looking statements. We also posted supplemental slides on our website at investor.viatris.com. Viatris routinely posts information that may be important to investors on this website, and we use this website address as a means of disclosing material information to the public in a broad, nonexclusionary manner for purposes of the SEC's Regulation Fair Disclosure.

We also will be referring to certain non-GAAP financial measures, including free cash flow and adjusted EBITDA. We will reference such measures in order to supplement your understanding and assessment of our second quarter 2021 financial results and financial guidance for 2021. Non-GAAP measures should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP. The most directly comparable GAAP measures as well as reconciliations of the non-GAAP measures to those GAAP measures are available in our second quarter 2021 earnings release and supplemental earnings slides as well as in the Investors section of our website.

In addition, solely to supplement your understanding and assessment of our second quarter 2021 financial performance, we have provided, in our earnings release and supplemental slides, and will discuss during today's call certain financial measures relating to the second quarter of 2020, including combined results of legacy Mylan and the Upjohn business with indicated adjustments which do not reflect pro forma results in accordance with ASC 805 or Article 11 of Regulation S-X. Such measures also do not reflect the effect of any purchase accounting adjustments.

Let me also remind you that the information discussed during this call, except for the participants' questions, is the property of Viatris and cannot be recorded or rebroadcast without Viatris' expressed written permission. An archived copy of today's call will be available on our website and will remain available for a limited time. With that, I'd like to turn the call over to Michael.

Thank you, Melissa, and good morning, and thank you all for joining us on our second quarterly earnings call as Viatris. I'm pleased to say that the strong execution we showed in the first quarter has continued into the second quarter. We are performing at or above the upper end of our own expectations across the entire business. All 4 of our commercial segments, all 3 of our product categories, our manufacturing operations, our R&D and our enabling function and thereby laying a solid foundation for future performance.

Today's strong results are not only a testament to the flawless execution of our colleagues who have quickly come together as one Viatris team but also validate the vision and the strategy we have in combining the 2 legacy organizations. The combination brought together 2 highly complementary, high-quality, investment-grade companies creating an even stronger, more powerful, unique and differentiated global platform, focused on empowering people worldwide to live healthy at every stage of life by ensuring patient access to safe, effective and high-quality medicines.

Mylan brought Viatris portfolio diversity, a rich R&D pipeline, strong internal scientific capabilities and proven integration expertise. And Upjohn provided strong iconic brands, a global commercial engine and scale in critical markets. The result is an even stronger future-ready and resilient platform with enhanced global scale and geographic reach, a sustainable, diverse and differentiated portfolio and pipeline, a powerful operating platform and strong commercial capabilities with significant future potential and the power to generate strong and sustainable cash flows. And today marks the second consecutive quarter in which we have demonstrated our ability to drive the value of this combination, and we remain confident in our outlook.

Now let me dive into the quarter. In the second quarter, we reported total revenue of USD 4.58 billion, adjusted EBITDA of $1.68 billion and free cash flow of $470 million. For the first half of the year, meaning quarter 1 and quarter 2 combined, we have generated $1.27 billion in free cash flow, more than half of our initial guidance for the full year.

Free cash flow generation continues to be our north star. Our unique global platform has the ability to consistently generate substantial free cash flows, and we anticipate significant increases in the coming years, driven by continued strong performance, a reduction in onetime cost and continued improvements in cash flow conversion. And given how critical cash flow is to our long-term financials, our strategy and commitment to shareholders, the Board has also made it one of the key metrics of management's short- and long-term compensation.

But performance extends not only to our commercial segments but also to our operations. Even in the midst of a COVID-19 pandemic and our ongoing supply network optimization efforts, we have seen customer service levels that are at or above historic peaks. And I continue to be impressed with our internal R&D engine and scientific capabilities. In July, we received a historic approval from the U.S. Food and Drug Administration for the industry's first-ever interchangeable biosimilar product in the U.S., Semglee or insulin glargine. We're extremely proud of this achievement, which will help broaden access to this important diabetes medicine for patients, for physicians, for payers and for providers.

And as you know from what's said by FDA and policymakers throughout the government, there is significant interest in this approval and what it can mean for patients and the health care system overall, both now and in the future. The interchangeable assembly product, which will allow for substitution for the reference product at the pharmacy counter, will be introduced before the end of the year.

Assembly is not the only advancement in our pipeline this quarter. With regard to our biosimilar and complex products pipeline, we're making steady progress across multiple programs, which Rajiv will discuss in more detail. Overall, we generated $224 million in new product revenue, and we continue to be on track for $690 million in new product revenue for the full year.

This high level of performance enables us to continue to deliver on our commitments. We've paid down $1.15 billion in debt year-to-date, and we're well on track to achieve $6.5 billion in debt repayment by 2023. In June, we returned value to shareholders by paying our first quarterly dividend of $0.11 per share, and the Viatris Board has declared another $0.11 per share dividend for the next quarter. And we're on track to achieve $500 million in synergies this year and on track for at least $1 billion by the end of 2023.

On last quarter's earnings call, I said that we would reassess guidance for the full year. Based on our strong first and second quarter performance, I'm pleased to report that we are raising our guidance across revenue, adjusted EBITDA and free cash flow, which Sanjeev will discuss in more detail. We have strong momentum going to the second half of the year, and we will be once again open to reassessing financial guidance at the end of the third quarter.

Also on last earnings call, I stated that we see $6.2 billion in adjusted EBITDA as a true floor of our business going forward. And with the momentum we have, this is now clearer than ever. We also continue to make good progress in our rigorous bottom-up strategic planning effort. By better understanding how our portfolio will evolve over the next several years and looking at all the strategic levers at our disposal, we will be better able to serve patients, provide increased access to medicine and unlock value for our shareholders. And that work will complete towards the end of the year.

Lastly, and as I've already mentioned, I cannot emphasize enough the impressive R&D engine and scientific capabilities that we have. As we prepare to deliver our strategic plan, you can fully expect that we will continue to add high-value assets to our pipeline and further leverage our scientific expertise and R&D platform. With that said, now let me turn it over to Rajiv for more details about our segment results, pipeline progress and restructuring and integration efforts. Rajiv?

Thank you, Michael, and good morning, everyone. We had another strong quarter and are very pleased with the positive momentum across our entire business, driven by strong commercial performance, supported by excellent customer service levels, continued scientific execution of our diversified pipeline, including a historic first approval of an interchangeable biosimilar to insulin glargine. This was achieved while we continue to successfully integrate fee structure and navigate the COVID-19 pandemic. Our performance would not be possible without the dedication of our global workforce, and I would like to thank them for their continued commitment.

Over the next several slides, I will walk you through the performance in each of our segments and product categories. I will be making certain comparisons to the combined LOE adjusted second quarter 2020 results on a constant currency basis as well as comparisons versus our expectations as included in our initial guidance.

Beginning on Slide 6. Each of our segments and product categories delivered a strong performance. When excluding the impact of Japan's Lyrica and Celebrex LOEs, as seen on the bottom left-hand side of the slide, net sales were up 4% this quarter as compared to the combined LOE adjusted quarter 2 2020 results. Our brand business grew by 3% year-over-year and performed better than our expectations. We are pleased to report that our global biosimilar portfolio grew by 40% this quarter, while our overall complex generics and biosimilars category declined by 8% year-over-year, mainly due to anticipated competition on certain products in our complex generics portfolio.

Our global generics business grew by 8% year-over-year and performed better than our expectations. We delivered $224 million for new launches in the second quarter. And as we look ahead, we remain on track to meet our $690 million target in 2021. We believe that the diversity of our portfolio and commercial reach positions us well to balance the impact of any changes in the market and eliminate our reliance on any one product or geography. Accordingly, we expect our base business to continue to perform strongly.

Turning to Slide 7. Our Developed Markets segment grew by 2% year-over-year. This was primarily driven by brands like Yupelri, Dymista and Creon. Our thrombosis portfolio also performed better than expected, which continues to highlight our ability to effectively manage and grow established brands and expand our presence in the hospital segment. Our biosimilars performed strongly with 47% growth this quarter, which helped offset the negative impact of the previously anticipated competition to Wixela and XULANE. Our generics portfolio also performed better than our expectations, primarily driven by our U.S. injectables portfolio, as well as favorable COVID-related buying patterns in Europe. Having said that, we see our biosimilars portfolio driving continued growth while offsetting anticipated competition in our complex generics space.

Moving to the next slide. Our Emerging Markets segment delivered 12% year-over-year growth and performed better than our expectations. Brands like Viagra and Lyrica drove strong performance as certain countries started recovering from COVID. Our better-than-expected results of our generics business was helped by certain COVID-related products.

The next slide shows that our JANZ segment grew 6% year-over-year and performed in line with our expectations. Our brand portfolio of products like Lyrica and EpiPen primarily contributed to the strong performance of Japan. We continue to be pleased with the growth of our generics business in JANZ, especially the contribution from our expanded authorized generics offering, including authorized generics to Lyrica and Celebrex. It should be noted that approximately half of the overall generics growth is due to the termination of our collaboration with Pfizer from the prior year.

The next slide is our last segment slide and shows that our Greater China business once again delivered a strong performance, which was better than our expectations. Our retail channel showed double-digit growth, and our hospital channel performed better than our expectations while managing the impact of VBP and URP. The 3% year-over-year decline was driven by anticipated VBP implementation of Celebrex and Zoloft. As we look at the rest of the year, we anticipate the full year to be better than our original expectations, although we see the second half being softer than the first because of the implementation of URP.

Now turning to Slide 12, which highlights our proven track record of introducing several first-to-market complex products. Breaking down barriers goes beyond best-in-class science. And right from day 1, our cross-functional team of R&D, regulatory, legal, medical, and policy experts worked diligently and collaboratively with regulators, partners and other stakeholders to seek and create pathways to clear hurdles that enable access. It can take, on average, 7 to 9 years from development to regulatory approval, given the highly complex nature of these molecules. Getting to the finish line requires tremendous perseverance, tenacity and an unwavering commitment to patients. The success stories of receiving the first approval for our Copaxone 40-milligram, Advair, Neulasta, Herceptin, Symbicort, and most recently, the first interchangeable biosimilar to the Lantus, give us great confidence that we are well positioned to deliver on our pipeline. We intend to leverage our deep scientific capabilities to further expand access to the complex products for patients.

I will now walk you through some key pipeline updates starting on Slide 13. As it relates to our biosimilars' key pipeline, I would like to take a moment to echo Michael's remarks and applaud the efforts of so many Viatris colleagues who played a huge role in achieving this historic FDA approval of the first interchangeable biosimilar, Semglee. We look forward to launch this exciting opportunity before the end of the year.

Moving to [F Park], a pre-approval inspection from FDA of Biocon's manufacturing facility in Malaysia is now scheduled for the end of this quarter. Scientifically, we believe we are on track to achieve interchangeability for F Park which should further expand our portfolio of interchangeable insulin.

We remain on schedule for a submission in quarter 4 of this year for EYLEA. Our program for BOTOX is progressing well, and we have a meeting scheduled with the FDA in September of this year to align on our path forward.

Moving to biosimilar to Avastin. While we have no open scientific questions with the FDA, our U.S. approval has been impacted by the delay in a pre-approval inspection due to COVID travel restrictions. The same product has been approved by TGA, MHRA and several other regulators.

As you will see on the next slide, we continue to make steady progress on our complex product programs and have some important upcoming milestones. We submitted our 505(b)(2) application to FDA for our levothyroxine oral solution in June, as planned. For our meloxicam, we expect an IND submission with Phase IIb study planned for quarter 4 this year. We are excited with the progress of our new low-dose formulation of XULANE, and we plan to initiate our clinical dosing for our Phase III program in September.

We also continue to make comprehensive progress on our complex injectable pipeline. We are happy to report that we are first to file on paliperidone once/3 months product if led to Invega TRINZA on the 546-milligram and 829-milligram strengths. The remaining strengths of 410 and 273 milligrams have already been submitted and are pending acceptance from FDA.

Before I conclude, I would like to touch upon our integration and restructuring activities. Since closing the transaction almost 9 months ago, our teams have been hard at work to ensure no business disruption. We remain on track to realize $500 million of cost synergies this year and confident in our overall plans to achieve at least $1 billion of cost synergies by 2023. Let me now turn the call over to Sanjeev. Thank you.

Thank you, and good morning, everyone. As Michael and Rajiv mentioned, we had another strong quarter with better-than-expected revenue, adjusted EBITDA and cash flow generation. These results demonstrate the underlying strength of our business and the momentum we have going into rest of the year. In slides ahead, I will make comparison to prior year Mylan standalone, combined adjusted for Viatris and the factors that are leading to an increase in our 2021 guidance.

On Slide 17, we have summarized our results versus prior year on a reported basis, which reflects Mylan's standalone results for quarter 2 2020.

Moving to Slide 18. We've highlighted the drivers in the quarter compared to combined adjusted Q2 2020 results. This chart reflects the sum of Mylan's standalone results and Upjohn's carve-out financials for a period of April 1, 2020 to June 30, 2020, adjusted for certain LOEs and transaction-related items, including divested products in connection with the combination.

A few key comments on this slide, beginning with Lyrica and Celebrex LOE. While we continue to see anticipated decline versus last year, our commercial teams have done a nice job in managing rate of erosion as the generic penetration levels have come in better than our expectations. Adjusting for LOEs, operationally, total net sales in the quarter were up 4%. This growth was driven by strong demand across Yupelri, Dymista, the thrombosis portfolio, Viagra and the new product revenue.

Base business erosion was driven by price declines in our generic business and was in line with our expectation and also anticipated competition across 3 of our complex products. For example, competition in Wixela, XULANE and PERFOROMIST contributed to base erosion in the quarter. This erosion was partially offset by 40% growth of our global biosimilar portfolio. For the year, we continue to expect base business erosion to be approximately 3% to 4%.

As compared to Q2 2020, COVID had a positive impact in the quarter, primarily due to full recovery in China and partial recovery in emerging market in Europe. Given the evolving COVID situation, for the remainder of the year, we currently expect a slower recovery than originally anticipated across key markets. Lastly, with respect to foreign exchange, the weaker dollar relative to key currencies, such as euro and Chinese renminbi, provided an approximately 4% tailwind compared to our combined adjusted 2020 results.

Moving to Slide 19 which bridges adjusted EBITDA. In the quarter, we had a higher run rate of inventory write-off, which had a negative impact on our gross margin. We don't expect this level of write-offs to continue in the subsequent quarters. As mentioned previously and as expected, base business erosion was predominantly driven by competitive pressure on high-margin complex products, and to a lesser extent, anticipated price decline across rest of the portfolio in North America and Europe. As you look at gross margin, it is down slightly on a sequential basis. This is primarily driven by anticipated product mix and the higher inventory write-offs. Integration and restructuring activities remain on track and SG&A was in line with our expectations.

Turning to Slide 20. For quarter 2 2021, free cash flow generation was strong and better than expected at $470 million. As I highlighted during quarter 1, free cash flow declined versus quarter 1 due to increased onetime cash cost, interest payment in Q2 and increased operational working capital and CapEx. I'm encouraged by higher-than-expected adjusted EBITDA to cash flow conversion and year-to-date cash flow of approximately $1.3 billion. This is net of approximately $800 million in onetime cost. The results reflect the organization focus and company's commitment to cash flow, and we are seeing an early benefit from cash flow improvement initiatives.

Turning to balance sheet. Year-to-date, we have reduced our debt by approximately $1.2 billion, which reflects a repayment of June $2.2 billion maturity, partially offset by lower-than-anticipated increase in our [Q term] short-term balance. In the quarter, cash was used for the European thrombosis transaction and dividend payment to the shareholders. We also extended our $4 billion revolving credit facility to a 5-year term, and for the first time, incorporated the option to include sustainability metrics consistent with our future corporate ESG goals.

Moving to Slide 22. Based on underlying strength of our business, we're raising our full year 2021 guidance for total revenue, adjusted EBITDA and free cash flow. The expected increase in revenue was driven by stronger performance in the underlying business. This includes the lower than previously anticipated full year impact of URP in the Greater China region, year-to-date tailwind from foreign exchange rate, lower generic penetration for Lyrica in Japan and sustained strength from brand. Partially offsetting these positive trends include anticipated competition in North America, lower generic volume in emerging markets and slower COVID recovery.

As a result of increased top line expectation and margin pull-through on these items, we are also raising our adjusted EBITDA guidance. This includes SG&A investment that is now expected to bring us to the high end of the range of 20.5% to 21.5% as a percentage of total revenue. Free cash flow guidance has also been increased as a result of higher adjusted EBITDA, lower cash taxes and continued cash flow improvement initiatives. With respect to key metrics underlying our financial guidance, which are largely unchanged, we have lowered our adjusted effective tax rate to be in the range of 17% to 18% due to the favorable mix of income across our tax jurisdiction.

Now with few comments on second half phasing. We now expect second half revenue to be slightly lower than first half. This is primarily driven by anticipated competition in select brands and complex generics and expected lower sales of COVID-related products. With respect to Greater China, we anticipate slightly lower revenue as a result of VBP and URP timing.

Moving to adjusted EBITDA. While the strength in the base business continues, we'll also expect competition to negatively impact gross margin slightly in the second half of the year. In addition, we are assuming R&D and SG&A investment to sequentially pick up, which we expect will help fuel long-term sustainability and growth of the business. We're also expecting the second half free cash flow phasing will be impacted by timing of capital expenditure. The underlying strength and momentum we see in business and solid execution gives us confidence in the outlook for the back half of 2021 and I believe positions us for a solid starting point heading into 2022.

As we mentioned previously, we expect onetime cash cost to decrease significantly over the next 2 years to historical Mylan level of approximately $500 million. With the momentum we have built and what we can see to date, our 3-year cash outlook makes us highly confident that we will meet our stated objectives of potential dividend growth, $6.5 billion of debt paydown by 2023 and increased financial flexibility for the company going forward.

Overall, I am very pleased with the execution I've seen and our ability to deliver on our commitments.

With that, let me open the call for Q&A.

(Operator Instructions) We'll take our first question from Chris Schott of JPMorgan.

I guess my question was just on the branded performance, it looks like you've had a couple of quarters now of stronger-than-expected results. And I'm trying to get my hands around, is this a situation where if the guidance was conservative and you're seeing later-than-expected competitive pressures? Or are you actually seeing improving fundamentals in some of these assets? I'm trying to get my hands around, is this kind of a near-term phenomena or something we should be kind of anticipating could persist longer term if actually some of these underlying assets are outperforming your expectations.

Thank you, Chris. And I think I'll pass the question to Rajiv.

So Chris, it's a great question, and thanks for that. I think our -- you see our confidence in our underlying business. As we put our arms around the business, as the new team has taken over, new country manager and the regional heads, we definitely see the momentum. We definitely see we can do more with the -- as I said, we are taking into consideration while we are looking into our long-term strat plan at what -- how best we can leverage our capabilities now as the 2 teams have come together and get more out of these assets. There are some bright spots, and the pandemic has also played some role.

So I think -- I don't want to jump ahead, but I see wind behind us here. I see the momentum, and I think when we come to you with our strat plan, we'll be able to give you a better appreciation about what we can get out of this branded portfolio. But we are very excited how this, so far, this has played out.

And Chris, the only thing I would add is the performance is no accident, right? This is executing by the team at the highest level. You see better performance on some of the key brands like Viagra, Dymista. The thrombosis business that we took over, Aspen, we're growing it actually. And you see very good execution against our strategy in China and much better results there than we had originally expected. So it's not an accidental result.

Your next question is from Elliot Wilbur of Raymond James.

A question for Michael and for Sanjeev as well. Could you just maybe -- given -- I guess, given all the different moving parts here and the complexities of combining the 2 businesses, could you just maybe walk us through the top 3 to 4 items that led to the upward revision in operating cash flow and your free cash flow outlook for the year?

And look, let me just make a general comment and then pass it over to Sanjeev to walk you through the details. We're -- have 2 quarters on our belt now. We continue to manage this business, and we're getting more and more confident, actually, in our ability, not only to deliver against the plan, but also improve free cash flow conversion, in addition to the strength you get from the underlying business, going forward, the reduction in onetime costs. So we feel very good about our ability to generate cash flow and to grow that over the coming years. And Sanjeev, do you want to give a little bit more (inaudible) the quarter?

Sure. Elliot, thank you for the question. So a couple of things that are going on. Obviously, as you pointed out, the cash flow from operations is improving because we've improved our adjusted EBITDA guidance, so that is clearly helping on that.

The second big part is, which is all the effort that we began as we brought the companies together, is working on all the working capital improvement initiatives. We're looking at all these elements in the balance sheet, AR/AP inventory, and those are beginning to contribute in that.

The third aspect is the modest benefit because of the lower cash tax that we see for the remainder in the year.

So overall, those 3 items are contributing to our increase in free cash flow, not only for rest of the year, but I see that momentum exiting into next year. As Michael pointed out, that -- as we look at 3-year cash flow horizon, as the onetime costs come down, as the strength of base business continues and we continue to work on cash improvement opportunities, I feel highly confident in our ability to pay $6.5 billion of debt and continue to grow the dividend.

Your next question is from Umer Raffat of Evercore.

Congrats on all the progress to date. I wanted to focus on one of your key growth drivers going forward, and you've mentioned an EYLEA biosimilar for -- your expectation is you could be on the market as the first to launch in 2024. If I think about the IP estate, what that basically means is you're assuming EYLEA's composition patent on expires late '23, plus the pediatric exclusivity, which means you basically launch right after the composition patent plus pediatric exclusivity. How confident are you that their non-composition patents won't be relevant to your launch? And can you speak to that?

Okay. So I'll let Rajiv comment on the order of entry and the -- if you want to comment on the IP situation. But Umer, let me just back up and make maybe a general comment here is that EYLEA, to me, this -- the interchangeability on Lantus, I mean, these are all proof points, I think, that we have that our biosimilar portfolio is strong. It's going to be a driver of growth going forward and something to be very proud of, right? The approval of Semglee (inaudible) is historic. And EYLEA, look, we're -- the number of competitors going into it, we're leading right now. And we're the first one to finish clinical trial, and we feel very proud about this. Rajiv, do you want to give some more details?

Yes. Umer, thanks for your question. Umer, If I have to parse your question when it comes to the biosimilars data, and EYLEA falls right there, there are 3 buckets: one is science, which I think we are very proud of and very confident of navigating it successfully. Second is very integral to IP legal spread, which I'm so proud of that if I look back into this biosimilar that which we never knew that when we were 5, 7 years back when we were planning, we had -- we saw this host of patients around there because of the patient linkages. We saw -- the whole thing was evolving around the patient [dance] and all that. When I look into the performance, how we have performed, whether it was insulin, whether it's Herceptin, Neulasta, Hulio, Avastin. And then similarly, as we were doing EYLEA, our IPR is evolving simultaneously, approach of combining it and deploying it IPR strategy or how to do [manage the patient term], all that is evolving, and it will continue to evolve. But that gives us the confidence that, backed by the science and our IP legal strategy, we'll be there to open the market in the first phase, if not the first. We're very confident and are very bullish on this product.

Your next question is from Balaji Prasad of Barclays.

Congratulations. Maybe just following up on biosimilar Avastin. You called out the delay in -- pre-approval restriction is delayed because of delayed travel. Since you're expecting [F Park] inspection at the end of this quarter, I imagine this is an Indian facility that you're expecting approval from. So are there any other key approvals that you're anticipating from yours or Biocon's facilities in India that could be delayed?

Rajiv?

Yes. Thanks, Michael. Balaji, [F Park] is not from Indian location. F Park is from Malaysia, and this pre-approval inspection is already delayed -- sorry, already scheduled. In the next few weeks, we'll be having that. So that's one product. I think Avastin is the only product from the Biocon which has been impacted, and we continue to work closely with Biocon and FDA to act -- how expeditiously we can get it released.

Your next question is from Jason Gerberry of Bank of America.

First, can you confirm now you're at the beyond the 5-year statute limitations on the generic drug price fixing subpoena, which have -- more than 5 years out, but I know there can be tolling agreements and COVID-related delays that could extend upon that. So just curious if you could confirm you're out of the woods with the price fixing matters that are an issue for other generic suppliers.

And then just on China and URP, can you help dimensionalize a little bit what's going on there, like the proportion of your $500 million-plus revenue per quarter run rate right now that is potentially exposed to URP versus the proportion of that that's perhaps growing due to this retail market growth dynamic?

Sure. Jason, thanks for the question. Look, on the price fixing, our position hasn't changed at all. We believe that the claims against us are without merit, and we're going to continue to defend them vigorously as we have. So there's really no change there. On the URP question with China, maybe, Rajiv, you can give a little bit more color to the composition of the revenue that Jason's asking for.

I start going right there. I would just want to go back and compliment the China team for the strong performance. They've done a great job in managing the VBP, the whole of steady how to manage VBP and shift the business and how VBP and URP has been now deployed has given us enough time to implement our own strategy. And that's why you see our business performing better than our expectations over a year. And we will be definitely starting from a better base as we go into '22 in health care consumerism, evolution of private insurance, private hospitals and also the market expansion we are seeing are the other drivers behind that.

So as we know, dimensionalize the URP, as we have already said repeatedly, that URP -- the decline of China business will be determined by how fast and the extent of URP implementation, which has been varying from province to province and all that. We definitely see this decline but maybe much different or lesser rate than what we saw earlier anticipating.

And Jason, one other point, just to kind of -- for you to understand the phasing of this business into this year. We obviously, as both Michael and Rajiv pointed out, are performing better than expected, both in hospital and retail channels. The second half of this year, we're going to see a step-down in the revenue, starting with third quarter for Greater China region, because of the timing of VBP. So that's all anticipated in the guidance, reflected in the guidance. It is doing better than what we had originally anticipated, but you will see a step-down in the second half versus first half.

Right. And we're starting off a higher base as we go into '22.

Your next question is from Nathan Rich of Goldman Sachs.

Sanjeev, maybe just following up on your previous comments in the last question. It seems like the performance, so far, would kind of put you on track to kind of be above the EBITDA range. I know you guys made comments about phasing with respect to competition in China URP and also COVID. But it seems like, I guess, in total, those headwinds would then have to amount to something like $400 million to get you kind of back to the midpoint of your full year guidance. So I was wondering if you could maybe just comment on some of those moving pieces for the back half as we think about sizing them as we do our models for the year.

Yes, yes. So listen, there are a lot of things going on. We're very, very pleased with the performance, strength of the business, all segments, all product grouping and the momentum we have getting into the second half. So there are a couple of things that are going on, and I'll walk you through, both on the revenue and EBITDA lines.

So revenue line, starting with that. So we talked about China, again performing better than our expectation, but we'll expect a step-down in the second half because of the timing of COVID and VBP. The second part we have is the anticipated competition in products like Wixela, XULANE, PERFOROMIST, all reflected in the -- in our guidance, but that will have an impact in the second half versus first half, and that will have an impact on our gross margin as well.

And then you have, to a lesser extent, you have some of the COVID-related buying that happened in quarter 2 that's going to step down in quarter 3, quarter 4. Put all those things together, you will see roughly second half revenue to be lower than the first half, though the underlying strength of the business continues.

Now taking the EBITDA, exactly some of these elements that I mentioned, will have a flow-through impact on the gross margin, even though I expect the gross margin for full year to be in the range of 58% to 59%. The other important item that's having an effect on the EBITDA is the pickup sequentially on SG&A and R&D expenses. And that's all, again, reflected in the guidance. We're expecting the SG&A and R&D to pick up, part of it is COVID, but part of it is deliberate design of investing into the business so that we have, not only achieved our objective for this year, but have a stronger momentum getting into next year. All those are reflecting in the EBITDA for second half to be slightly lower, but again, was strong.

And on the cash flow, again, the performance, strength and everything continues that I mentioned about it, the working capital improvement initiatives, better cash flow from operations and the higher -- the only offsetting on the cash flow side is the higher CapEx that we expect in the second half versus the first half, which is on the timing of that. So that kind of gives you the sense of the rhythm of all 3 items.

And we'll be reassessing again as we see the quarter evolve whether we need to give further updates to the guidance or not.

Your next question is from Greg Fraser of Truist.

On China, can you comment on your expectations for new product introductions from the legacy Mylan portfolio? How should we think about the time line for product submissions and potential approvals?

Yes. Rajiv, can you just comment on the submissions we already made and what's to come?

Yes. I think there are 2 components to that. One is our existing business in China, especially the strength of Upjohn -- legacy Upjohn business, we will be able to get more out of the Mylan legacy portfolio than what Mylan was doing with their limited presence. That's one piece.

The second piece is the new products, which, without losing every time, we have -- as we said, we have identified about 30 products now. Six of them are scheduled for filing over this year. Three have already been filed, so we are very much on the track. And I think from a regulatory point of view, it takes about 2 to 3 years to get these products over the finish line when it comes to China.

Your next question is from Gary Nachman of BMO Capital Markets.

On the interchangeability approval for Semglee, just talk about the challenges getting that done, how difficult for other companies to potentially get that interchangeability as well for insulin? So what are sort of the barriers to entry there? That would be helpful.

And then just talk about the plans for the launch later this year. So how are you thinking about pricing dynamics and formulary acceptance and potential share capture? And how much is factored in the $690 million guidance for new products for Semglee? Is there anything meaningful in there?

Gary, thank you. Before I hand it over to Rajiv, let me just add a few, I would say, a little bit of color to this and what this means because this is really a historic first approval of interchangeability for any biosimilar in the U.S. And the path to that is not always a straight one. The regulatory landscape has evolved. We've evolved with it, and I think we should be so proud of what we have done as a team in enabling this and being tenacious enough to evolve with it and sticking to it and actually getting this done.

There's significant interest, as you know, from policymakers, from advocacy groups, et cetera, and what this potentially can mean for access for patients. And it's, to be honest, meaningful for me on a personal level because, 20 years ago, I led the global marketing effort for (inaudible) launch. So I know what this product can do, how good is [a patient]. We're excited about -- specifically what this means, and we're excited what this potentially means for patients. And I want to ask Rajiv to comment on the commercial potential and the time line also that we see in rolling this out.

Yes. And one other question was about how difficult is interchangeability, and I would say, look, Gary, ideally suited products for interchangeability of a chronically administered biosimilars where disease needs to be relatively stable and with a limited chance of rapid decline, and it's a case by case. And it does include -- the current guidance across for the biosimilars on interchangeability includes pharmacokinetic equivalence after 3 switches of test reference, test versus the reference product. So there is additional work and science involved.

Now coming back to the launch, very excited and very proud of this achievement. It's a new level with the new NDC and FDA has agreed with us a framework to transition in the interchangeable product while transitioning out the non-interchangeable. And we had agreed also in the time frame of a period of about 6 months to manage this, which aligns well with ramping up our supply of interchangeable markets.

From a commercial point of view, if anybody knows this market, this market is not just commercial, driven by the just formularies or PBMs. This is made up of Medicare Part D., the second one controlled by the PBMs. The third one, Medicaid, the government, VA hospital, corrections, cash pay and FFS. And every market channel segment has its own dynamics and nuances, so there is no one silver bullet or one strategy to commercialize.

Our goal would be to basically drive the excess, and we believe that the substitution at the pharmacy level will help us drive that. And we see, from a timing perspective, we see some -- you will see some uptick in the market share around quarter 4, but the actual and the decent impact of interchangeability to the market share perspective and excess will be seen over the next year.

For us, I see this as a long-term opportunity with a long tail. And interchangeability -- and just one thing I've missed, I think, on your question around how long, we do have 12-month exclusivity for any other interchangeable product to come. So I think I've answered most of your questions.

And, Gary, one of the things -- this has got no bearing on $690 million for this year. That's -- this is going to be, as Rajiv pointed out, bigger impact next year.

Your next question is from Navann Ty of Citi.

Just a follow-up on URP, and thanks for the color you just provided. Do you still expect URP to limit reimbursement to VBP pricing? And can you comment on the early impact or any qualitative comments that you can make for 2022?

Yes. So let me take the '22 question first, and I'll let Rajiv talk about the URP and how we see that rolling out, which is it's heterogeneous. It's province to province, and we're getting more and more clarity on that.

But on the '22 question, let me just reemphasize again what I also said in my prepared remarks is that we really see the $6.2 billion true floor for this business. I think with the performance we have under our belt now from both the first and the second quarter, it's more clear than ever to us that that's the case.

We have really strong momentum coming from both, and that's for EBITDA. Clearly, we see cash flow growing. That's because of the continued performance and where we see EBITDA. It's from reduction in onetime costs, and Sanjeev was very clear about where we see legacy Mylan levels by the end of 2023. So you see the improvement that can come from just that factor.

And then as we've seen in this quarter, I know on capital and cash flow conversion, cash flow very strongly. And then if you ask about revenue, we're not really talking about revenue yet. I mean we are completing the strategy plan that we're doing. That will be completed towards the end of the year. That gives us -- we'll be able to give you much more clarity on the trajectory about where we are. But in summary, we feel good about where we are. Rajiv, do you want to comment on the URP question?

Yes. I think the VBP or URP from the policy point of view is absolutely out and is being gradually implemented. And it's -- Michael said it right. It's heterogenous, and it's also evolving. There a couple of provinces where they have taken it all the way to the VBP price. But the big provinces like Shanghai and Beijing, they are doing it in a gradual way. Maybe there are some provinces are doing -- reducing the price to the 50% of the VBP price. And others, we have seen 30%. So it's evolving, and it's heterogenous.

Your next question is from David Amsellem of Piper Sandler.

So sorry if I missed this, but can you just talk about how you're thinking about the trajectory of EpiPen beyond this year, particularly with the sort of uptick in the market as a result of vaccinations. Are you in front of that and party to that? So just give us your general thoughts on trajectory of that other product-specific questions? Any color on how you're thinking about launch timing or approval timing for iron sucrose and also injected for that would be helpful.

Okay. I think Rajiv, I give that straight to you, EpiPen, a little bit rhythm of the numbers there and then anything on pipeline launches.

Yes. EpiPen has been and will continue to be a meaningful product from our global business point of view. It's just not the U.S. market because, even in U.S., we have been holding on to about mid-30s of the market share despite this being a multiple market now between (inaudible). It will continue to be a meaningful product. Actually, we are more excited how the traction and the market share or the excitement we have seen in Europe and many other emerging markets. So as we expand, as we further build upon this franchise, this is one of the products which will be taking it across other geographies and expanding it globally.

Do you want to hit the question on iron sucrose?

Yes. So iron sucrose is most likely to -- going be a '22 launch.

Very good. Thank you, Rajiv. Operator, last question, please?

And that was your final question. I will now turn the call back to Michael Goettler, CEO, to make a few closing remarks.

Well, thank you for all the questions. And look, in summary, I just want to say again, we're outperforming at or above the upper end of our own expectation across the business. We feel good where we are. We're meeting our financial commitments. That includes the dividend. That includes the debt paydown. We're on track on synergies, and we're delivering very strong and sustainable free cash flow generation. I think this quarter has made that very visible. We'll continue to make good progress on our pipeline, and Rajiv highlighted a few of those, including the historic approvals of assembly interchangeability.

We've raised the guidance for 2021. And I want to reiterate again, $6.2 billion is the true floor of this business in terms of adjusted EBITDA, and that's more kind of at or above that level going forward. And lastly, we've embarked on a robust bottom-up work will complete by the end of the year, and we look really forward to communicating that with you when it's completed.

So thank you very much, and that concludes the call for today. Thank you.

This does conclude today's Viatris 2021 Second Quarter Earnings Call and Webcast. Please disconnect your lines at this time, and have a wonderful day.