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Viatris Q3 2021 Earnings Call Transcript

Operator

Good morning. My name is Leo, and I will be your conference operator today. At this time, I would like to welcome everyone to the Viatris 2021 Third Quarter Earnings Call and Webcast. [Operator Instructions] After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions]

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

Melissa Trombetta
Head of Investor Relations at Viatris

Thank you, operator, Good morning everyone. Welcome to Viatris' third 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, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure, Reg FD.

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 third quarter 2021 financial results and financial guidance for 2021. Non-GAAP measures should not be considered as 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 third 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 third 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 third 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 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 participant 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.

Michael Goettler
Chief Executive Officer at Viatris

Thank you, Melissa, and good morning, and thank you for joining us on our third quarter earnings call. I'm pleased to say that we have again reported another strong quarter, generating robust free cash flow, delivering on our financial commitments, and building a strong foundation for our future. Nearly one year ago today, we formed Viatris with the vision to assemble best-in-class capabilities across commercial, manufacturing, R&D, and enabling function in pursuit of removing barriers and expanding access for patients we serve, while also returning value to shareholders.

Today's continued strong results are a testament to that vision and to the execution of our colleagues around the world who share dedication to patients and shareholders drives our strong business results and we believe is putting Viatris on a path for an even stronger future. I could not be proud of all that we have accomplished together. And here are some highlights.

In the third quarter, we reported total revenues of $4.54 billion, adjusted EBITDA of $1.7 billion, and free cash flow of $965 million. Year-to-date, that is quarter one through quarter three combined, we have generated approximately $2.2 billion in free cash flow, already exceeding the lower end of our most recent guidance for the full year. Optimizing cash flow generation will continue to be our financial North Star and we anticipate cash flow to grow in the coming years as a result of our expected continued strong performance, reduction in one-time cost, and continued improvements in cash flow conversion.

In North America, we preparing for the imminent launch of Semglee, which as most of you know received historic approval from the FDA for the industry's first ever interchangeable biosimilar designation in the US in July. We expect that Semglee will be available in pharmacies before the end of the year and we believe this is an important milestone to help increase access to insulin for those living with diabetes in the United States. Rajiv will later provide more details on the progress we are making in that regard.

In addition, at the end of October, we filed a BLA for our biosimilar to Eylea with the FDA as planned. We believe this is the first biosimilar registration of this important medicine to treat age-related macular degeneration. And looking further into the future, we are excited about the potential to be first to market for our BOTOX biosimilar. Overall, we generated $158 million in new product revenue in the third quarter, $557 million year-to-date and we are, therefore, well on track for approximately $690 million in new product revenue for the full year.

Importantly, our strong performance enables us to continue to execute on Phase 1 of our strategic roadmap, which is expected to be completed by the end of 2023. During this time, we are focused on strengthening our balance sheet, returning capital to shareholders in form of a dividend, and building a strong foundation for the future. We're now one year into that three-year effort and we continue to deliver on our financial commitments for debt repayment, dividend, and synergies.

On the last quarter's earnings call, we said we would re-evaluate our 2021 financial guidance at the end of the third quarter. Based on our strong performance to-date, we are again raising our financial guidance across total revenue, adjusted EBITDA, and free cash flow which Sanjeev will discuss in more detail later.

I'm also pleased to say that we are near completion of our rigorous bottom-up strategic planning effort. We look forward to sharing the results of these plans with the investment community at a virtual investor event now scheduled for the morning of January 7, 2022, and on that day, we provide additional details on our two-phased strategic roadmap, including for the rest of Phase 1, that is the years 2022 and 2023. We'll be providing specific financial guidance, targets, and metrics to complete the phase. We'll also be discussing the substantial free cash flow that we will be generating over this period to satisfy our Phase 1 capital allocation priorities of returning capital to shareholders and of repaying $6.5 billion of debt. And with that said, we continue to remain confident that $6.2 billion of adjusted EBITDA is the true floor of our business.

For Phase 2 of our roadmap, that's 2024 and beyond, we will provide an overview of the catalyst that we expect will drive future growth, including laying out our capital allocation priorities for the space in order to maximize and further unlock shareholder value during this period. We'll also be giving specific details of our own organic opportunities by discussing our own pipeline at length and will be providing the inorganic business development priorities that we will be focusing on through our Global Healthcare Gateway.

Before I close, I'd be remiss to not call out that Viatris was recently recognized as a Top 5 Company on the prestigious Fortune's Change the World list. This recognition is a testament to the hard work and dedication of our colleagues to stem the tide of HIV-AIDS over the course of more than 10 years and it's just one example of our corporate social responsibilities deeply embedded in our mission and our operating model. And in addition, we were recognized on the Forbes 2021 World's Best Employers list, underscoring our success in laying the foundation for the kind of company we want to be.

And with that, I'll turn it over to Rajiv for more details. Rajiv?

Rajiv Malik
President at Viatris

Thank you, Michael, and good morning, everyone.

Before I get into the quarter at hand, I would like to echo Michael's excitement about our upcoming investor event, but you can expect to hear from me is a comprehensive review of the significant value and the depth of our pipeline and clinical programs including biosimilars, complex genetics in our medicines that we have been strategically building over many years. These development programs are expected to play a significant role in our ability to drive organic growth over time, especially as our cost synergies roll off at the end of 2023. Once laid out in January, we believe our pipeline will be recognized as one of the company's most under-appreciated assets that will enable us to continue to deliver value, while fulfilling our mission of expanding access and addressing patient needs.

Now let's get into our results. I'm pleased to report that we have executed three strong quarters which is a testament to our diversified and differentiated commercial and operations platform, but more importantly, the dedication of our workforce. As I walk you through the performance in each of our segments and product categories, I will be making certain comparisons to combined LOE adjusted third quarter 2020 results on a constant currency basis, as well as comparisons versus our expectations as included in our guidance back in August.

Beginning on Slide 7, overall the business performed strongly across all of our segments versus our expectations. When excluding the impact of Japan's Lyrica and Celebrex LOEs, as seen on the bottom left-hand side of the slide, total net sales were down 1% as compared to combined LOE adjusted quarter three 2020 results. Our brand business performed better than our expectations primarily driven by Lipitor, Viagra, Influvac, and EpiPen. Our complex generics and biosimilar category performed in line with our expectations. We are pleased with the continued growth of our global biosimilars portfolio this quarter, which grew by 14% and helped to offset anticipated competition related to select complex generic products. Lastly, our global generics category also performed in line with our expectations, reflecting mid single digit decline compared to the prior year.

Turning to Slide 8, our developed market performance was slightly above our expectations for the quarter. Europe continues to perform very well, generating 10% year-over-year growth in net sales, driven by strong performance by brands like Influvac, Lipitor and Dymista as well as the strong performance of our thrombosis portfolio. Biosimilars in Europe grew by over 50%, led by our strong position of Hulio in Germany.

Moving to North America, we are very pleased with our overall performance. Our branded segment performed strongly driven by EpiPen, Yupelri and a better than expected performance of Perforomist. These results were partially offset by Miacalcin which experienced unanticipated competition. Complex generics and biosimilars in North America was better than our expectations with strong performance in biosimilars which help to absorb the competitive impact on Wixela and Xulane.

I would also like to make a few comments on US generics business and pricing. For the last few years, we have continued to work on our portfolio by investing in science and difficult to make dosage forms like injectables, dermatologicals, patches and drug device combinations while pruning certain commodity products at the same time. We believe we now have a very diversified generics portfolio, which is being very well supported by our strong customer service levels. This is what differentiates our ability to effectively manage this business.

Accordingly, as we normalize this quarter for exceptional one-time events like dimethyl fumarate, Wixela and Xulane, our price erosion for this quarter is mid single digit and very much in line with our expectations. We are also excited about the upcoming launch of our branded product, Semglee injection and unbranded insulin glargine injection. Both products will be available in pen and vial presentations and are interchangeable for the reference brand Lantus. This dual product approach is intended to ensure that this interchangeable biosimilar insulin can reach as many patients as possible, regardless of financial circumstances, insurance, or channel.

We are pleased with some recent formulary wins that go into effect on January 1, 2022 including the inclusion of our interchangeable biosimilar Semglee on Express Scripts' National Preferred Formulary as well as on Prime Therapeutics National Formularies. We expect that the products will be available in pharmacies before the end of the year. To ensure that as many patients as possible will benefit from these products, we will provide co-pay assistance, a patient assistance program and cash pay alternatives. In addition, beginning in '22, we will be a participant in the CMS Medicare Part D Senior Savings Model, which limit certain patients' out-of-pocket cost to no more than $1.35 for one month supply.

Moving to the next slide, our emerging market segment also performed in line with our expectations this quarter. Our branded business primarily driven by Viagra and Lipitor continues to perform strongly in these countries that have begun to recover from COVID. In this quarter, our complex generics and biosimilars category performed below our expectations due to the COVID-19 related regulatory delays, which we expect to overcome as we close-out the year. Our generics business was in line with our expectations. We had higher than anticipated sale of remdesivir and ambisome this quarter that helped offset the lower ARV volume. We expect that the demand for COVID-19 related products to taper off in quarter four.

The next slide shows our JANZ segment. We are pleased with this quarter's performance across our product categories with brands and generics performing better than expectations. Amitiza, Lyrica, and Creon drove strong brand results and our authorized generics to Lyrica and Norvasc continue to contribute growth. Biosimilars were in line with expectations, with continued strong performance from Hulio in Japan.

Greater China is our last segment slide, and the business had another strong quarter delivering results that were better than our expectations. This performance was primarily driven by retail channel growth of 20% and better than expected performance in the hospital channel. The segment benefited from some phasing of customer buying patterns this quarter that we expect to normalize in quarter four. Overall, we are very pleased with how the business is navigating the evolving policy environment. With our new launches performing to our expectations and our base business anticipated to be in line with our expectations of approximately a 4% base business erosion for the year, I feel very strong about the underlying building blocks of this business.

Now turning to the pipeline update. Regarding our BOTOX biosimilar development program, we met with FDA in early September and aligned on analytical, non-clinical data, as well as the clinical program expectations and have a clear path forward. At this juncture, we do not expect Revance 483 and a complete response letter related to their DAXI product to impact our submission timing for this program, which is scheduled to be filed by the end of 2024. We will provide an additional update when we have more information. Additionally, we recently submitted to FDA what we believe is potentially the first Eylea biosimilar.

Moving to Insulin Aspart, FDA completed a pre-approval inspection of Biocon's manufacturing facility in Malaysia. It resulted in a few minor 483 observations and Biocon has provided a complete and comprehensive response to have TS 483. We are confident that we will hear soon from the agency as this is a large remaining element needed for approval of another potentially interchangeable insulin product. Regarding Avastin, our US approval continues to be impacted by the delay of a pre-approval inspection. As previously mentioned, we have no open scientific questions with FDA.

In our complex product pipeline, we have initiated a Xulane lower dose Phase III clinical trial and are actively screening and enrolling patients. We are also happy that our levothyroxine oral solution was accepted for filing with the FDA. This quarter, we made good progress in our complex injectables portfolio. We successfully completed pivotal pharmacokinetic studies for our long-acting Octreotide Acetate injection and have demonstrated that our product is bioequivalent to Sandostatin.

Our Paliperidone Palmitate three months ANDA for 410 milligram and 273 milligram strengths have now been accepted for filing and we believe that we are the first to file for all strengths of the Paliperidone three month lipoinjection that's equivalent Invega TRINZA. We have also successfully completed our pivotal PK-study for Aripiprazole modified release injection, which is our generic equivalent for Abilify Maintena.

Before I hand it over to Sanjeev, I'll quickly address our ongoing integration and restructuring activities. We are coming up on our one-year anniversary and our initiatives are progressing as planned. We continue to remain on track to realize $500 million of cost synergies this year and are 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.

Sanjeev Narula
Chief Financial Officer at Viatris

Thank you, and good morning, everyone.

As Michael and Rajiv mentioned, we had another excellent quarter and I'm really pleased with the focus and execution exemplified by our team, especially the financial results. The results demonstrate the financial strength and the nature of our global diversified platform. In the slides ahead, I'll provide drivers for Q3 and the expectation for Q4 that are leading to an increase in our current year financial guidance. On Slide 17, we have summarized our results versus prior year on a reported basis, which reflects Mylan's standalone results for third quarter 2020.

Moving to Slide 18, this is a comparison of combined adjusted Q3 2020 results which includes Mylan's standalone results and Upjohn's carve-out financials for a period of July 1, 2020 to September 30, 2020, adjusted for LOEs and transaction-related items including divested products in connection with the combination.

Beginning with LOEs, as we've seen throughout the year, our commercial teams have continued to manage the rate of erosion of Lyrica and Celebrex in Japan. As a result, generic penetration levels have come in slightly better than our expectations. Adjusting for these LOEs, total reported net sales in the quarter were essentially flat to prior year. In the quarter, our branded business performed solidly driven by thrombosis and Influvac in Europe and EpiPen in North America. In China, sales were strong for both Lipitor and Norvasc in the hospital channel and Viagra in the retail channel.

Our team continues to navigate the policy environment and erosion from VBP was in line with expectations. New product revenue was in line with expectation and our global biosimilar sales grew 14%. Base business erosion includes price and volume decline in our North America genetics business, including competition across complex products such as Wixela, Xulane, Miacalcin, and our generic for Tecfidera, coupled with declines in our ARV business in the emerging market, on balance, these items are tracking in line with our expectation and full year assumption is unchanged at approximately 4%.

We're seeing a gradual recovery from COVID in emerging markets, North America and Europe. Lastly, with respect to foreign exchange, the weaker dollar relative to key currencies such as Europe provide an approximately 1% tailwind compared to our combined adjusted 2020 revenue results.

Moving to Slide 19, which bridges adjusted EBITDA. In the quarter, adjusted gross margin of approximately 60% came in ahead of expectation and were driven by brand performance and favorable cost of goods. Integration and restructuring activities remain on track and SG&A was in line with expectations.

Turning to Slide 20, free cash flow of $965 million exceeded our expectation due to strong operational performance and cash flow improvement initiatives. One-time costs were lower due to timing effectivities between quarter three and quarter four and capital expenditure came in below our expectation, partially due to COVID-related global supply chain delays. As a result of strong year-to-date free cash flow of approximately $2.2 billion, we've been able to repay $1.9 billion of debt year-to-date, including $730 million in quarter three.

We've also returned $266 million in dividends to our shareholders. These actions are consistent with our phase one capital allocation priorities of repaying $6.5 billion of debt by 2023 and returning capital through a dividend, which we expect to grow in future subject to Board approval. As we look to Q4, we expect free cash flow to be significantly reduced from Q3 levels due to lower adjusted EBITDA phasing of one-time cash cost, semi-annual interest payments, and ramp-up of capital expenditure.

Moving to Slide 22, based on the underlying strength in the business, we're raising the guidance for total revenue, adjusted EBITDA, and free cash flow. The midpoint of increased total revenue guidance is now $17.8 billion, an increase of $100 million versus prior guidance. The increased outlook of revenue reflects the continued strength in our China business, driven by pull-through of retail convergence strategy. Performance in developed market is benefited from strong EpiPen back to school season and Influvac volumes in Europe, partially offsetting these positive trends, including generic erosion and competition of key products in North America and lower ERV volumes in emerging markets. The midpoint of an increased adjusted EBITDA guidance is now at $6.4 billion, also up $100 million versus prior guidance. The increase is primarily driven by higher forecasted total revenue in addition to our expectation that adjusted gross margin will land closer to the high end of our range at 58% to 59% for 2021.

For adjusted SG&A, we expect a sequential increase in fourth quarter with the resumption of activities due to COVID recovery in various market, bringing our full year range of this key measure to 21% to 22% of total revenue. The midpoint of free cash flow guidance is increasing to $2.5 billion, which is $200 million higher than previous guidance. This reflects capital expenditure of approximately $500 million, lower cash tax, and cash improvement initiatives that we expect to continue to benefit us in 2022 and beyond.

Now few comments on Q4. For revenue, we expect a sequential decline due to customer buying pattern that benefited in Q3, lower sales of EpiPen in developed market, and lower sales of remdesivir and ambisome in emerging markets. For adjusted gross margin, we also expect a sequential step down from Q3 to Q4 from 60% to approximately 58% due to the evolution of our product portfolio mix. I'm extremely pleased with our ability to generate substantial free cash flows and we fully expect our operational momentum exiting 2021 will carry into next year.

Based on additional cash flow improvement initiatives and the expected reduction in one-time cash cost, we are highly confident on our clear pathway to generate an aggregate of over $8 billion of free cash flow from '21 to '23 that will satisfy our Phase 1 capital allocation priorities. The underlying strength and momentum we see in the business position us for a solid starting point heading into 2022. And we look forward to sharing more about two phase strategic roadmap in early January.

Before I turn the call over to the operator, I'd like to announce that our Head of Investor Relations. Melissa Trombetta, is moving to a broader leadership role in our office of business performance. We sincerely appreciate all her contribution over past four and a half years, leading the IR function. Going forward, Bill Szablewski, Head of Capital Market and Luis Sanay, Director of Investor Relations will be the main contact for the investor community.

With that, let me open the call for Q&As. Operator?

Operator

[Operator Instructions] We'll take our first question from Chris Schott of JPMorgan.

Chris Schott
Analyst at JPMorgan Chase & Co.

Great. Thanks so much for the questions. I know you're targeting a January 7 Analyst Meeting, but do appreciate the comment on, I think, it was $6.2 billion in EBITDA as a floor for the business. I guess my question here was, I think in the past you've talked about 2021 as a trough number. I know you've raised the guidance a few times you have gone through this year. So, let me just understand a little bit what's going on here. Some of the upside we're seeing, I guess more one-time in nature this year or are there any other factors that contribute to that dynamic? I'm just trying to kind of bridge between I guess a new midpoint of $6.4 billion versus that floor of $6.2 billion?

I think I will slip a really quick second question in. I guess my question is, when you think about like capital deployment and where your stock is right now, where is repo -- share of repo fit into the mix and I think there's been a lot of discussion around like BD and/or owned dividends, but just want a sense -- get a sense of, is share repo something that you're considering as well? Thanks so much.

Sanjeev Narula
Chief Financial Officer at Viatris

Hi, good morning, Chris, and thanks for the question. Let me start with your second question on the share buybacks. Just to go back, I mean, for us as part of our TSR framework, from the beginning, we always contemplated both dividends and share repurchases. That was always part of our thinking. I think we've been very, very clear about what our priorities are for Phase 1 which is the years '21, '22 and '23. And that's the debt pay down $6.5 billion, returning capital through dividend, and then growing that dividend annually, right. If there are additional opportunities, obviously we'll consider it. Share buybacks will always be the benchmark for any kind of major BD investments that we do.

And then just one other factor that you may not be aware of that we have to consider is, there is a Tax Matters Agreement that we entered into with Pfizer, as part of the tax-free spin of Upjohn from Pfizer and then the combination with Mylan. And there are certain limitations and conditions on share buybacks in the first two years that we need to take into consideration. But I look forward to telling you more not only about the Phase 1 commitment we've made very clear, but also our capital deployment priorities for Phase 2, how we do that and how we maximize shareholder value and unlock further share of value in Phase 2. So that's forthcoming and please join us in the January meeting.

On the EBITDA question you have, clearly we're not giving guidance today. We're very, very pleased with the performance that we have now three consecutive quarters. We strongly feel that we stabilized this business. We get a good handle on the business. We now finished or almost finished the bottom up rigorous strategic planning process. And with that, we reconfirm again what we said before, the $6.2 billion is the floor. That means floor, doesn't mean midpoint of the guidance. It's a floor. But that's a floor that's very, very important, because that drives how we can deliver on Phase 1, right. We laid out our clear priorities what we need to do. EBITDA drives cash flow. It's not the only thing that's driving cash flow, it's one of the things driving cash flow and we remain confident that the EBITDA combined with, and you can easily do the math yourself, $8 billion or more in cash flow over those three years sets us up to deliver on our Phase 1 commitments.

We remain confident we can do so and, look, just this year, $2.5 billion midpoint already. And that sets us up really for very successful Phase 2 with a much stronger balance sheet, much more increased financial flexibility and firepower. And I look forward to telling you more about that at our investor event. Next question, please.

Operator

We'll take our next question from Umer Raffat of Evercore.

Umer Raffat
Analyst at Evercore ISI

Hi guys, I'll also ask one question, which is two questions. Michael, I know there's been a lot of investor questions and confusion around dividend payout and I'm curious if we should expect a more definitive number, let's say, a 20% payout or something as we go to January 7 Investor Day. And then Rajiv, I'm trying to understand some of your comments around or talks of biosimilar a little better. I know you were scheduled to have conversations with FDA in September is what you had said last time. You also just said that the Revance complete response on manufacturing deficiency should not impact your 2024 timing.

So, I'm just trying to put those two things together. I guess, what specifically was the FDA focused on when you sat down with them in September? And is your manufacturing process and manufacturing location for biosimilar BOTOX shared with Revance? Thank you.

Michael Goettler
Chief Executive Officer at Viatris

Okay. I'll start with the dividend and, Rajiv, if you can answer the second question. Umer, thanks for the question. Dividend is obviously key component of our TSR story going forward and what you should expect from us is a growing dividend in absolute dollars, subject to Board approval, of course. But I don't want to get ahead of the Board of Directors here, but my hope is that we will be able to declare on 2022 dividend framework in time or at the January 7 event. And I think we can be confident that we can do the math around cash flow by that we have sufficient cash to pay down the debt and grow the dividend and we'll tell you more about that later.

Rajiv Malik
President at Viatris

And thanks Umer for your question regarding BOTOX. You're right, we met with the FDA in early September and have a clear alignment on their expectations about biosimilarity, analytical, non-clinical data, as well as clinical program expectations. So, once you have that clarity and we have a clear path forward, it's all about execution. And we have been on this at this place several times and most important thing is to get a firm alignment with FDA. When I say firm alignment, yes, these things evolve, but at this moment, they have given us a very clear understanding and they are motivated to see a biosimilar product come through in the market.

Regarding the Revance, yes, we -- Revance is our development as well as manufacturing partner and we share the facility which is our advanced facility for DAXI and getting 483 or a complete response letter is not a new thing when you are evolving or developing a product. Towards the end of '24, that's what we have our filing date. We have a lot of time. And as we said, as we have been giving you complete transparency, we'll keep you guys updated as it was, but at this juncture, I don't see that CRL is going to impact our development program timing.

Operator

We'll take our next question is from Elliot Wilbur of Raymond James.

Elliot Wilbur
Analyst at Raymond James

Thanks. Good morning. Wanted to ask a question around synergy realization over the course of the year and I apologize, some of the lines were cut off. I may have missed this during Rajiv's prepared commentary, but just wanted to get an update on where you were in terms of realizing the $500 million in targeted synergies, which buckets are over-performing or underperforming versus original expectations?

And then just looking at the numbers in terms of SG&A and R&D, targeted spend percentages and those numbers on an absolute basis as well as COGS, they're not really moving lower. So how should we think about the progression of those numbers kind of on an absolute basis as we move toward that ultimate target of $1 billion in synergies. Thanks.

Michael Goettler
Chief Executive Officer at Viatris

Okay. So thank you, Elliot. Quick answer on the synergies, we are absolutely on track with the $500 million and we're confident of the $1 billion for the three years and I'll give it to Rajiv maybe to give a more nuanced answer. And then the SG&A, R&D and COGS question maybe between you and...

Rajiv Malik
President at Viatris

Michael you've said, everything which we have laid out over the different buckets, whether it was cost avoidance from the cost of goods, from the SG&A, everything is on track. I don't see any -- we are right on track as far as our '21 target is concerned. We have a great plan for '22 and '23 and we remain committed to beat or meet and beat this $1 billion target as we go along.

Sanjeev Narula
Chief Financial Officer at Viatris

Rajiv, you uncovered that very well. Elliot, just one of the thing to keep in mind, the synergies Rajiv pointed out is covering all line items and that's where it is going to reflect. What you should expect when we provide the guidance, the absolute dollar for SG&A will come down next year based on the flow through of the synergy and we'll provide more clarity and detail when we meet on January 7. Next question, please.

Operator

We'll take our next question from Jason Gerberry of Bank of America.

Jason Gerberry
Analyst at Bank of America

Hey, guys, thanks for taking my question. My question is on China and just as we think about the $300 million headwind that was talked about heading into the year. It looks like it's unimpacted, the URP price impact probably pushed out to next year arguably, which is probably the big swing factor with the floor, EBITDA floor as we think about that next year. So I'm just curious, are you seeing anything on the China retail side which has been a growth story that suggest some of this upside that you are seeing in China in '21 is sustainable.

And if I could just squeeze in a point of clarification, there was mention about out of pocket assistance on Semglee, which I would think of as a generic having negligible patient out of pocket cost. So if you could just provide some clarity on what the co-pay differential would look like on a Semglee versus an established brand, that would be helpful. Thanks.

Michael Goettler
Chief Executive Officer at Viatris

Rajiv, I think, you can answer both questions.

Rajiv Malik
President at Viatris

Okay. So, Jason, on China, we could not be more pleased with our performance and how our China team or management team of China is evolving and navigating through the evolving -- very fast evolving policy environment. Yes, we have done -- the team has done a great job of shifting the -- maximizing what they have in the hospital channel. We are doing better than our expectation in the hospital channel as well as the growth in the retail channel. And this is where the focus for the future is that we continue to shift our focus and build our momentum around the retail channel, which is growing toward -- this quarter also it was 20% plus growth.

But as China evolves, we always said that although we are not providing guidance, but we knew that China is going to be a step down, whether it's year one or two given the implementation of URP. In fact, recently, there has been some updates on the -- at the policy level in China where we are pleased that in a perverse way it has provided us now very clear clarity about the timing and extent and we see this bottoming out of the China business, our hospital business by '24, '25. That gives us a great runway to continue to implement our business and move the business, where we need to move and focus and build the portfolio around the retail. So that's about China.

And as well as Semglee, I think the launch of the two products, the new drug launch is intended to ensure that this interchangeable product can reach as many patients as possible regardless of financial circumstances, insurance or channels and we just want to be at par or not any of the patient should be going back from the pharmacy point or dispensing point because they don't have a equivalent co-pay assistant or patient assistant program or cash pay alternative. So we are trying to match every -- get every map every patient and provide them whatever we can provide or whatever they are getting today from a Sanofi product.

Michael Goettler
Chief Executive Officer at Viatris

Thank you. Next question, please.

Operator

Our next question is from Balaji Prasad of Barclays.

Balaji Prasad
Analyst at Barclays

Hi, good morning and congratulations on the results. Just following up on the biosimilars and the interchangeability part, I would like to get your thoughts on how relevant you think interchangeability will be for the biosimilar Humira landscape? And on the same subject, with Semglee, market exposure that we spoke to believe that Semglee can potentially increase its volumes like 4x to 5x, again don't want to steal your thunder from your Jan event, but curious to hear your thoughts on it. Thanks.

Michael Goettler
Chief Executive Officer at Viatris

Rajiv?

Rajiv Malik
President at Viatris

Yeah. So, Balaji, interchangeability if I were to characterize interchangeability of Humira, I will put it in a nice to have bucket rather than a must have bucket, for a number of reasons. So, first of all, as you know, as the market formation happens, nobody will have the advantage of interchangeability as Amgen or the number two player will not have interchangeability at that point of time, but more importantly, the difference between Insulin Aspart and Humira is about, insulin is a pharmacy product whereas Humira is a specialty pharmacy product where at the point of dispensing you have a lot better controlled and interaction between the doctor and the patients, ongoing interaction.

At the same time also, today nobody will have interchangeability for all the presentation, the low concentration, the high concentration, the pen versus a prefilled syringe. So there will be -- somebody will have a -- it maybe Boehringer has one for the strength for the lower concentration, but not for all. So you know -- and even if it's a, let's say, nice to have, you can expect us that it's such an important product. By the time the first exclusivity expires, the interchangeability exclusively expires, which will be somewhere in the '24 or about, we might have -- we will be having that interchangeability. We will go after and complete that interchangeability work.

Michael Goettler
Chief Executive Officer at Viatris

Great, thank you, Rajiv. Okay, next question please.

Operator

Our next question is from Greg Fraser of Truist Securities.

Greg Fraser
Analyst at Truist Securities

Good morning, folks. Thanks for taking the question. You mentioned discussing the potential of your Global Healthcare Gateway for Phase 2 on the strategic roadmap. Should we think about inorganic growth driven by the Gateway as more of a longer term opportunity or will the gateway be open for business before then? Thanks.

Michael Goettler
Chief Executive Officer at Viatris

Okay. Thank you, Greg. Look, I think we said it clearly, the gateway is open for business. We have I think unique opportunity here of having this really amazing platform that makes us the partner of choice, both more we build commercially, operationally, R&D, regulatory, etc., with the scale, we have the reach and we can offer that to partners and have ready access. We also said that we are very clear about our capital allocation priorities that we are going to be very disciplined in the way we do that. But should the right opportunity presents itself, we are absolutely able to execute on it. And I'll give you more guidance in terms of what we -- what the priorities are for business development of Global Healthcare Gateway for Phase 2 at our January 7 event.

Thank you for the question. Next question, please.

Operator

Our next question is from Navann Ty of Citigroup.

Navann Ty
Analyst at Smith Barney Citigroup

Hi, good morning. Can you give us more details on what drove the better free cash flow for your guidance? And maybe if you could discuss the improvement, the cash improvement initiatives and should we expect a higher free cash flow growth in 2022 above the reduction in one-time costs? And then I just have a follow-up on China. Do you expect a more benign URP impact or just a postponement of the reform? Thank you.

Michael Goettler
Chief Executive Officer at Viatris

Okay. So, Sanjeev, why don't you take the free cash flow question?

Sanjeev Narula
Chief Financial Officer at Viatris

Sure. Yeah. Navann, we are very pleased with the cash flow generation in the company and all the effort and the focus that we have on the cash flow in terms of that. So what's going on in terms of where we are looking at kind of the opportunity? So first is obviously the operational rhythm of the business is better as Michael and Rajiv pointed out. So that's obviously helping on that. Then on top of that, as a company, we've implemented a very comprehensive cash optimization program as we brought the two companies together. So we looked at every element of the balance sheet, as you would expect that. We looked at where net working capital is deployed, whether it's account receivable, accounts payable and inventory and other working capital. We looked at that, we looked at the best practices in the both company and obviously trying to gravitate towards the best practice. And we're looking at the industry as well.

So we came up with the program that we are kind of implementing it right now. What we also did is, we looked at the operational metrics and had each of the asset owner start driving those that we can see the benefit on that. The bottom line of this is, this is a very sustainable program at the grassroot levels in the organization, not only has seen, Navann, the benefit this year, but I see the benefit getting into next year and year after that. And as the one-time cost come down, which we are expecting that to come down next year and year after that, I see cash flow, our free cash flow to improve next year and year after that. And that will then satisfy -- we will have enough cash flow of $8 billion to satisfy Phase 1 commitment of debt pay down and paying and growing dividend subject to Board approval.

Michael Goettler
Chief Executive Officer at Viatris

Okay. And maybe on China, Navann, I think you clearly should expect further step downs. We always said that, we always anticipated that. We always factor that in. What was always unclear is the speed and timing of that because that's subject to further clarification on rules and how they are brought out etc. I think we have more clarity on that now. Obviously we're offsetting that by other factors that we have whether it's our retail business, whether it's our future pipeline etc. We'll give guidance on that again at the January 7 event. But we always anticipated a step down and we have good certainty around the timing of that now. Next question, please.

Operator

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

Gary Nachman
Analyst at BMO Capital Markets

Thanks. Good morning. In terms of the competitive dynamics for some key complex generics, is this in line, better, or worse than what you've been expecting? I'm curious if you're getting the returns on your complex generics that you expected a couple of years ago given competitive dynamics there. And then just gross margin, it showed good improvement relative to our expectations in the third quarter. So how should we think about that trending going forward? It will be down a little bit in 4Q, but what are some of the pushes and pulls there maybe going into next year? Thank you.

Michael Goettler
Chief Executive Officer at Viatris

Rajiv and then Sanjeev.

Rajiv Malik
President at Viatris

Yeah. No, the margin expectations and as well as the market dynamics of the complex products are exactly in line how we have anticipated. Of course, the market has evolved when we thought about these products maybe six, seven, eight years back to what we are, but we always expected slow ramp and longer annuity. And I would be so -- I'm looking -- I'm so far -- looking forward to walk you through how this new algorithm and a great return on investment on this bucket, whether it's a Wixela or a Copaxone or a Seretide, you can walk through -- we will walk through you those models. So we are very, in fact, excited and feeling bullish about this segment and that's why we have been investing in this segment over the years.

Sanjeev, on the gross margin...

Sanjeev Narula
Chief Financial Officer at Viatris

Sure. So, Gary, gross margin in quarter three came in ahead of our expectations, clearly, driven by strong brand performance, including Greater China region, and then we had one-time items in our cost of goods lined. Going forward, in Q4, I expect a step-down that is expected because of the evolving product mix that we have and then non-repeat of some of those one-time items in Q4.

But overall, for the year, we expect to end at the higher end of our range of 58% to 59%. Going forward, in 2022, again we'll provide the specific guidance in January, but we should think about and expect that the gross margin will continue to evolve. There is going to be slight pressure because of the evolving product mix that we have and that's all expected and we will obviously provide further guidance on January 7.

Michael Goettler
Chief Executive Officer at Viatris

Next question, please.

Operator

Next question is from Nathan Rich of Goldman Sachs.

Nathan Rich
Analyst at The Goldman Sachs Group

Good morning. Thanks for the questions. Sanjeev, maybe just on the cadence of earnings into 4Q, can you maybe talk about what drives the step-down in EBITDA? I know you talked about China as well as it seems like EpiPen sales might have been pulled forward a little bit, but fourth quarter is normally a seasonally strong quarter. So I'd just like to get a little bit more color on sort of the cadence for the final quarter of the year and kind of what gets you to the low versus the high end of the range? And then at a high level, are you kind of willing to maybe preview some of the key like tailwinds and headwinds that we should have in mind for '22 and '23 ahead of the Analyst Day? Thank you.

Sanjeev Narula
Chief Financial Officer at Viatris

So, Nathan, let me take the first one on the Q4. As you know, Viatris is a different company, it's got a different profile of revenue and what we are sharing with you in terms of the full-year guidance is reflective of the Viatris' portfolio. So at this -- let me say at the outset, I mean, there is nothing I see that concerns me regarding the underlying fundamentals of the business getting into Q4 or for that matter, exiting this year into beginning of next year. So on the -- all the items that I talked about in my prepared remarks had commentary on that, specifically for the EBITDA the question that you ask.

If you look at the kind of the step down in the revenue, which is all due to the expected events that explain that, there is a flow-through of the EBITDA going down. There is a gross margin pressure, I talked about that because of the evolving product mix and then you have some one-time events on the COGS line. The other thing that's also happening in Q4, which is obviously impacting the EBITDA level is this step up in the SG&A line. As we are seeing the world recovering from COVID, there is going to be step-up in the SG&A expenses, which actually helps us position well, not only this year, but sets up well for the next year. So all that is planned and expected, but, bottom line, there is nothing that is of concern to me about what's happening in Q4 for that matter.

Michael Goettler
Chief Executive Officer at Viatris

And maybe on the pushes and pull, Nate, look, here's what I feel very strongly about. We now have three quarters of very strong performance. We have a good handle on this business. Remember, we brought two big companies together, we had to learn the business, understand the business. I think we have a very good handle on it. We are near completion of a very rigorous, very thorough, high quality, bottom up strategic planning process and that really gives us increased confidence in understanding all the pushes of course of their business and you know of them all, right, they are not the secret, the China business, it's the base business erosion, that's part of the nature of our business, the LOEs that we know and expect.

And on the upside, that is -- the pipeline, the upcoming launches, I think we're going to lay out to you on Investor Day how the pipeline is really one of the most underappreciated assets that we have and our ability to generate really, really strong cash flow. So we are confident in our ability to deliver on all of our Phase 1 commitments that we laid out and it gives us -- kind of give us a great start for Phase 2 and look forward to telling you about Phase 2 when we come to the investor event.

Next question, please.

Operator

Our next question is from Ronny Gal of Bernstein.

Ronny Gal
Analyst at Sanford C. Bernstein

Good morning, and thank you for squeezing me in. Couple of actually really small points. First, your Eylea IPR was supposed to have been answered by the 5th of November, it seems to be delayed somewhat. Can you give us an update what's happening there? And second, I noticed the Orencia biosimilar that you're disclosing, a few other companies have tried that and found it's very hard to keep Orencia stable in storage, just the way the molecule is made. And I kind of wonder if you're over that hump and found a way to resolve it or is it still ahead of you?

Michael Goettler
Chief Executive Officer at Viatris

Rajiv?

Rajiv Malik
President at Viatris

Yeah, thanks. And regarding, Ronny, about Eylea, you are right. It's been delayed and it will -- we will know in another couple of weeks where we stand to the institution of IPR, okay. That you're correct, it's been delayed. And the second on Orencia, yeah, it's in development, it's challenging, it's hard. We tried it few -- a couple of years back. We had obviously the challenges like everybody else is having and we are seeing some light at the end of the tunnel and we continue to build the momentum on that program.

Michael Goettler
Chief Executive Officer at Viatris

Okay. Next question, please.

Operator

Our next question is from David Amsellem of Piper Sandler.

David Amsellem
Analyst at Piper Sandler Companies

Thanks. So wanted to ask a high-level question, just in light of what Novartis commented regarding Sandoz and particularly their challenges with their US business and then in light of how your business is formed and is evolving. Can you give us some color as to how you're thinking about your base US generics business and just your overall US small molecule retail presence over time, particularly the more commodity end of the business? Can you just talk to how you're thinking about that philosophically? Thanks.

Michael Goettler
Chief Executive Officer at Viatris

Sure. We are actually very happy to explain it. Rajiv?

Rajiv Malik
President at Viatris

Yeah. So, David, yes, US has been one of our core business and we have lived through the various cycles over the years. And for me, the cycles continue and there is nothing new. For the last few years, we knew how this business was evolving. There was a commodity bucket and there was still a bucket of hard to make and complex products. From science perspective, we continued to invest for several years to going up the value chain, so that's being off.

On the commodities where we saw that there is a power of the vertical integration, we still retained those. Where we see a huge competition and the commodity means actually turning out a commodity with a [indecipherable] market. We took the opportunity to prune that portfolio. And if we not pull together, we have a well diversified generics portfolio, which is being -- which is performing very well and as we expected. We have a strong customer service levels. Given what we are doing with the rationalization of facility or in the COVID, we have not missed a beat.

We have very strong service levels. So that puts on the great position to manage the challenges as well as grab the opportunity. So, we couldn't -- I think we feel good how we all started about this business. And if we normalize the one-time events like Tecfidera's LOE or loss of their exclusivity or Wixela and Xulane, we are right at where we forecasted mid single digit, mid single digit price erosion. So, thanks for your question.

Michael Goettler
Chief Executive Officer at Viatris

Yeah. Clearly we've done the work ahead of other companies. All right, thank you very much everybody for their question. We are unfortunately out of time. Let me just say, we're pleased with yet again another very, very strong quarter and we look forward to seeing you at our virtual investor event on January 7. Thank you very much.

Operator

[Operator Closing Remarks]

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