Viatris Inc. (VTRS) on Q4 2021 Results - Earnings Call Transcript
William Szablewski: Good morning, everyone. I'm Bill Szablewski, Global Head of Capital Markets for Viatris. It is my pleasure to welcome you to our Investor event. With us today is our CEO, Michael Goettler; our President, Rajiv Malik; and our CFO, Sanjeev Narula. We have a lot to share today regarding the reshaping of Viatris into a simpler, stronger and more focused company. But before we get started, I need to cover off a few disclaimers. During today's investor event, we will be making forward-looking statements on a number of matters, including our financial guidance for 2022 and various strategic initiatives. These forward-looking statements are subject to risks and uncertainties that could cause future results or events to differ materially from today's projections. Please refer to today's slide presentation or the press release that we furnished to the SEC on Form 8-K earlier today for a full explanation of those risks and uncertainties and the limits applicable to forward-looking statements. We will be referring to certain actual and projected financial metrics of Viatris on an adjusted basis, which are non-GAAP financial measures. We will refer to these measures as adjusted and present them to supplement your understanding and assessment of our financial performance. Non-GAAP measures should not be considered as a substitute for or superior to financial measures calculated in accordance with GAAP. The most direct comparable GAAP measures as well as reconciliations of non-GAAP measures to those GAAP measures are available on our website at investor.viatris.com and in the appendix of today's slide presentation. The information discussed during the presentation, except for the participant questions, is the property of Viatris and cannot be recorded or rebroadcast without Viatris' expressed written consent and permission. An archived copy of today's presentation, along with a replay of the webcast, will be available on our website at investor.vetris.com, following the conclusion of today's event. With that, now I'd like to hand it over to our CEO, Michael Goettler.
Michael Goettler: Thank you, Bill. And good morning, and welcome to Viatris 2022 Investor Event. This is truly an exciting day for all of us at Viatris; for our 37,000 colleagues around the world; and for our shareholders. Not only are we reporting strong financial results for the full year of 2021 meeting or exceeding our guidance. Today, we'll lay out for you exactly how we expect to deliver on our vision for Viatris. We'll further review with you our current pipeline, our scientific capabilities, our proven track record and how we intend to reshape our portfolio towards higher margin, more durable assets such as NCEs and 505(b)(2)s. And finally, we'll give you an update on our business performance and execution, our 2021 financial results and our 2022 guidance. Next slide, please. Now what you will see is a Viatris that is simpler, that is stronger and that is more focused. At Viatris we expect to deliver more access to patients and more value to shareholders with a durable higher-margin portfolio, significant financial flexibility and shareholder-friendly capital allocation and further enhanced commercial and scientific capabilities. And we'll lay out to you our very bold plan to reshape our company. And with today's announcement of the Biocon biosimilar transaction, we've already taken the first bold step to unlock value, accelerate our financial commitments and increase availability of capital for investing in our future or returning value to shareholders. Next slide, please. Viatris was created a little over a year ago, as you know, in November 2020, through the combination of Upjohn and Mylan. Our first year was focused in our immediate priorities of integrating the 2 companies and delevering our balance sheet. And we wasted no time. As you know, in December 2020, we already announced a significant global restructuring plan and executed against this plan. We defined and delivered clear financial targets, including our 2021 budget, our synergy targets, our goal to pay down $6.5 billion in debt by 2023 and the initiation and growth of a quarterly dividend. And I'm very pleased to say that we have now delivered 4 quarters consecutively of consistent and solid performance, meeting or exceeding our guidance. Sanjeev later will provide you more details on our full year 2021 results. Meanwhile, our pipeline achieved many significant milestones, including the historic approval of the first interchangeable biosimilar in the U.S. and the first approval of a generic to Restasis. Meanwhile, externally, we're recognized as one of the top 5 companies on Fortune's company that Changed the World list. We're recognized by Forbes as one of the World's Best Employers, and by Newsweek as one of America's Most Responsible Company. But most importantly, most importantly, through 2021, we conducted a thorough strategic review of our entire business. We determined what was core and what was noncore to the future of our company. And today, I'm excited to share with you the output of that review and the actions that we're taking. Today, we're announcing a significant global reshaping initiative. The Biocon biosimilar announcement is only the first-but-critical step to unlock value and reshape Viatris. And combined with other initiatives, we expect to significantly enhance our financial flexibility, accelerate our financial commitments and enable us to invest in our future, continuing to move up the value chain by expanding to more innovative areas and to return value to shareholders. Next slide, please. We're taking immediate and concrete actions to execute on that plan. To unlock value and to simplify our business beyond the Biocon biosimilar transaction, we've identified other select assets, which we expect will unlock additional value. And as we continue to execute against our plan, we will become more efficient, reduce complexity and make Viatris a simpler, stronger and more focused company. In total, we expect these initiatives to generate up to $9 billion in pretax proceeds by the end of 2023. And let me just put this in perspective. This is more than half of Viatris current market cap. In return, we're trading off approximately 20% of our current adjusted EBITDA. Sanjeev will provide you further details about our future financial profile later. And these proceeds will immediately accelerate our financial flexibility. Our financial commitments for Phase I, so that's the year '21, '22 and '23, remain unchanged: pay down $6.5 billion in debt, achieved $1 billion in synergies and grow our quarterly dividend to return value to shareholders. But in addition, we expect to have significant capital available to return to shareholders through share repurchases and/or investing in the growth of our business. And for this, the Board of Directors has already authorized a share repurchase program of up to $1 billion. Share buybacks will be an important benchmark for us as we make future capital allocation decisions and decide how to invest in our future. Our goal is to enhance our proven scientific capabilities and current global platform, including our Global Healthcare Gateway, to create a durable and higher-margin portfolio of products. And that means further expanding beyond our current scope into more innovative products, including NCEs and global 505(b)(2)s. And for that, we've identified 3 core global therapeutic areas: ophthalmology, gastrointestinal and dermatology. And that, we believe, will particularly fit our capabilities and our platform and where we have a credible path to leadership. We're also further enhancing our commercial and scientific capabilities as needed for this future portfolio. And we intend to double our R&D investment, ramping up steadily to approximately 9% of revenue by 2026 to bolster our pipeline organically. And we expect to inorganically grow via business development through our Global Health Care Gateway. Now I'll explain further details on that strategy later. But for now, I would like to hand it over to Rajiv for further details on the Biocon biosimilar transaction, and I'll come back later. Rajiv?
Rajiv Malik: Thank you, Michael. As Michael just outlined, we have identified certain assets as a part of an extensive strategic review. These assets have a potential to unlock the trapped value and are potentially noncore to the future direction of the company. These assets can generate up to approximately USD 9 billion of pretax total proceeds. The plan is being executed as we speak, and up to $3.335 billion of these proceeds will come from the Biocon transaction, which I will walk you through now. The transaction we announced today is the first step towards creating a simpler, stronger and more focused Viatris. Under the terms of the agreement, Viatris will contribute its biosimilars business to create what we expect to be a unique vertically integrated global biosimilars leader. It's not only the right natural next step for our partnership, but also a continuation of our biosimilars journey and enables us to participate in this space in a more optimized way while unlocking substantial trapped value. We believe this evolution positions Biocon Biologics to further optimize and maximize the biosimilars business. Viatris and Biocon started the journey together in 2009, even before the biosimilars regulatory pathway was defined in many markets. We had many successes together and continue to build upon our momentum by adding more products to our pipeline. Together as partners, we have seen this landscape evolve from a science, regulatory and customer perspective. Biosimilars are heading steadily towards a face of a mature market. And as was in the case of generics, vertical integration will prove to be decisive to stay ahead. We believe this transaction positions the company as a world-class vertically integrated biosimilars leader and will enable the new company to optimize end-to-end operational capabilities, serve market needs with competitive advantages and will have sustained power. The transaction is subject to customary closing conditions, including regulatory approvals. Viatris will receive total consideration of up to $3.335 billion. $3 billion of the consideration will be received immediately on closing, with $2 billion in cash and $1 billion of convertible preferred shares. Viatris also expects to receive deferred consideration up to $335 million. Viatris will own a stake of at least 12.9% of the combined business on a fully diluted basis. We currently expect the combined business operating as Biocon Biologics to commence an IPO in India by late '23. The deal consideration represents a transaction multiple of approximately 16.5x based on estimated '22 adjusted EBITDA of our biosimilar business of approximately $200 million. Under the terms of the agreement, Viatris will contribute its biosimilar business, which includes all the programs currently partnered with the Biocon; as well as our biosimilars program for Humira, Enbrel and EYLEA. To facilitate a smooth commercial and operational transition, we will provide via TSA select services such as commercial, regulatory and clinical. We will receive cost plus a markup of USD 44 million annually for the duration of TSA. Now I update on the share consideration. We will receive $1 billion of the convertible preferred shares that represent a stake of at least 12.9% on a fully diluted basis. We believe Viatris will be positioned to generate additional significant value through the potential upside of our ownership stake in the combined business. An IPO in India is targeted in late '23, and Viatris has a certain priority rights in IPO. Viatris will also receive customary anti-dilution and preemptive rights. On governance, Viatris will be granted 1 seat on the Board of Biocon Biologics. In terms of timing, while the transaction is subject to customary and regulatory closing conditions, we currently expect the transaction to close in the second half of '22. We expect the TSA services will end by quarter 4 of 2024. That transaction is an exciting evolution to our partnership with Biocon. I look forward to sharing more with you soon about how we will leverage the proceeds to reshape the Viatris for the future. Now I will turn it over to Sanjeev.
Sanjeev Narula: Thank you, Rajiv, and good morning, everyone. It's been an exciting day for Viatris. Today, we announced strong Q4 and full year 2021 results and financial guidance for 2022. We've entered into an agreement with Biocon Biologics for a total consideration of up to $3.335 billion. We've also announced a plan to reshape the company, which we expect to unlock additional value. In the next few slides, I'll walk you through the reshaping initiatives underway, how it strengthens our profile, accelerates financial flexibility and enhance our capital allocation framework. Slide 15 represents an illustrative pro forma for what Viatris could look like post closing of Biocon Biologics transaction and after execution of plan for other select assets. There are a few key takeaways to highlight. First, as a result of the partnership structure and profit-sharing arrangements of the biosimilar business, the estimated 2022 biosimilar adjusted EBITDA margin is relatively lower compared to our company average. Second, looking at pro forma company, total revenue and adjusted EBITDA will remain largely intact after the transactions. Next, the Biocon transaction at roughly 16x 2022 adjusted EBITDA and estimated proceeds from other select assets are expected to unlock significant value above our company's current valuation. Finally, we expect these transactions will significantly strengthen our financial profile, unlock up to $4 billion to $5 billion of after-tax proceeds that will be deployed for investing into business and returning capital to shareholders. Turning to Slide 16. We highlight our illustrative financial profile across revenue, profitability and the balance sheet. For revenue, we plan to complement annual product revenue of approximately $500 million with business development that is targeted towards assets that fit our strategic, commercial and financial criteria. These opportunities can come in from of regional tuck-ins, a therapeutic focused pipeline and a broader distribution type arrangements via our Global Health Care Gateway. For profitability, we expect gross margins to stabilize over time given the focus on complex products that are wholly owned and not subject to partnership payments. Given our track record of success and the value upside afforded by more durable, higher margin of complex products, we intend to increase our R&D investments. We expect SG&A to continue to benefit from synergies in 2022 and 2023, averaging out at approximately 20% of total revenue. And finally, upon closing of the Biocon transaction, our balance sheet will be immediately strengthened with $2 billion in pretax proceeds to accelerate our Phase I financial commitment. Now turning to Slide 17. We expect that the anticipated cash proceeds from Biocon transaction, along with the plan for other assets, will provide additional flexibility and enhance our capital allocation framework. Under Phase I, we intend to accelerate the base plan by retiring short-term debt in 2022. In total, we intend to pay down at least $6.5 billion of debt between '21 and '23 in order to reduce our gross leverage to approximately 3x by the end of 2023. We intend to increase R&D and pipeline investment for future health of the business. As a result, we're taking a more balanced approach to capital allocation and have revised our midpoint of long-term gross leverage target from 2.5x to 3x. With the anticipated proceeds from Biocon Biologics and other select asset transactions, we expect to accelerate investment into business and return more capital through potential share repurchases. We will take a measured approach and evaluate each option against our internal hurdle rate and other criteria. Now I'll turn it over to Michael.
Michael Goettler: Thank you, Sanjeev. Now as we said, we plan to expand our portfolio to more innovative and more durable assets such as NCEs and 505(b)(2)s, and we will do that in a very focused way. Now for this, we conducted a thorough analysis of our current strengths and capabilities, especially our scientific capabilities. We looked at market sizes and growth opportunities. We looked at the degree of unmet medical need and the opportunity for innovation, the availability of Phase II and Phase III late-stage assets. And we looked at who our competitors would be and who our prescribers are. And the results were clear. Some therapeutic areas had too much competition or too much scientific risk for us to see a credible path to leadership in the time horizon that we're looking at. Others were too small or didn't provide enough room for innovation. And as I already mentioned earlier, 3 therapy areas in particularly hit the sweet spot for us. That's ophthalmology, dermatology and gastrointestinal. Depending on the opportunity, we may not pursue all of these equally at the same time, but they represent the kind of therapeutic area where we have the ability to leverage our existing infrastructure and maximize the opportunities. Next slide, please. Viatris today already has a unique hybrid model with the requisite capability spanning from what is needed to be successful in the generic space, to a strong base for what is needed in the brand and innovator space. And we expect to further expand on the innovator capabilities as we hone in on the targeted therapeutic areas. Next slide, please. To build a durable portfolio of innovative assets, we already have a solid platform to build on. We already have a proven track record in development and have a true development powerhouse. Rajiv will talk about this a little bit later. We already have a global commercial infrastructure. We already have a best-in-class global supply chain, quality and operational excellence. And the Global Healthcare Gateway is the heart of the company as we leverage our existing platform and expand into more innovative areas. In fact, today, we're announcing that we already have entered into our first Global Healthcare Gateway transaction focused on ophthalmology, acquiring an exclusive license for Pimecrolimus ophthalmic ointment for the treatment of blepharitis, which is a very common type of eye irritation. Blepharitis affects about 6.5 million patients in the U.S. alone. And in the U.S., there's currently no product specifically indicated for chronic blepharitis. This product will contribute to ophthalmology franchise while we continue to search for an anchor asset. And the path to leadership for us starts with the acquisition of an anchor asset in 1 or more of the 3 therapeutic areas as well as expanded R&D investment in those areas. And it's through the Global Healthcare Gateway and our global platform that we believe we can leverage the full global potential of these assets, organically or inorganically add complementary growth assets in some of these therapeutic areas and then leverage the benefit of therapeutic area leadership and focus by leveraging the existing health care provider coverage, leveraging our existing development expertise, leveraging our existing medical expertise, leveraging the connections we have in the scientific community, et cetera. As I said, we see a clear path to therapeutic area leadership in one or several of the TAs that we identified. So let me summarize on the next slide. Viatris of the future is simpler, stronger and more focused. We have and are already executing on a clear plan to reshape the entire company and build a durable higher-margin portfolio consistent of generics, complex products and off-patent brands. We take some strategic actions on certain assets, but add an innovative growth engine of NCEs and 505(b)(2)s in our targeted therapeutic areas. And with this, we expect Viatris to have significant financial flexibility. In addition to debt paydown and dividend growth, we now expect to have the opportunity for increased R&D investment, for extensive BD activities as well as share buybacks. And finally, building on our current platform and capabilities, we intend to have further enhanced commercial and medical excellence with a focus on the identified therapeutic areas. Bottom line, a simpler, stronger and more focused company delivering access to patients and value to shareholders. With that, I'd like to hand it over to Rajiv now, who will be giving you more details on our pipeline and how we are further enhancing that pipeline in line with our strategic vision. Thank you. Rajiv.
Rajiv Malik: Thanks, again, Michael. I'm going to focus this next session on the role our strong development platform can play to achieve the end goal of going up the value chain. As we have already touched on, enhancing our R&D is an essential part to achieve the future direction of the company. I am very proud of many accomplishments of our science team over the years. As I see it, we are a development house with capabilities that can be further strengthened and focused in coming years as we continue to move up the value chain. We intend to leverage our Global Healthcare Gateway to further strengthen our R&D engine with differentiated and novel products that target gaps in care. We believe that we are an ideal development partner that offers strong science, regulatory and clinical skills as well as strong global commercial footprint to companies with Phase II and III assets. We'll continue to invest in generics with a focus on complexity and diligently pursue life-cycle management opportunities around our current therapeutic areas. We expect to ramp up our R&D investments steadily to approximately 9% of revenue by 2026. This slide shows our road map to execute our R&D evolution. On the left, you see where our portfolio and pipeline is today, which is a diverse across a wide range of therapeutic areas across segments and markets. We intend to continue to build the pipeline focusing on products with complexity and also investing in life-cycle management of certain key products in our current portfolio of various regions. I'll walk you through certain examples in one of my following pipeline slides. We will seek additional inorganic assets through our Global Healthcare Gateway around current therapeutic areas of regional focus. More importantly, we'll be aggressively looking into several Phase II and Phase III opportunities to build critical mass of new chemical entities and 505(b)(2)s novel products in the 3 focused therapeutic areas of GI, ophthalmology and dermatology, as Michael mentioned. In order to execute our R&D strategy, we will leverage the foundation that has been built over a number of years. This slide highlights our extensive scientific capabilities we have across a broad range of dosage forms and delivery mechanisms. We also have proven expertise in all of the related areas that are essential to develop and scale these types of products up through and including novel products. For example, the robust API and formulation development capabilities; the global expertise in preclinical study design and execution as well as device engineering, strong clinical development and medical affairs across multiple therapeutic areas; strong in-market regulatory, legal and IP skill sets; and broad and scalable manufacturing capabilities. The backbone of this platform is, of course, a strong team of 3,000 scientists and medical professionals working across 12 development centers and having regulatory expertise in 55 markets. We have a broad range of demonstrated clinical experience and have conducted over 80 clinical development and post-marketing programs, including Phase I, Phase II, Phase III and Phase IV studies. The bottom line is that we believe we are well positioned to support and enable the advancing of the science of the value chain. There is no better representation of our scientific expertise than this slide are proven results. When we make a decision to pursue the development of a complex generic or a novel product, our track record shows our commitment. On an average, complex products can take 7 to 9 years from development to approval. And we are so proud to bring most of these products first to the market. Recently, we added another first to our basket with the approval of generic Restasis, building off the momentum of our first interchangeable biosimilar assembly. I would like to dive a bit deeper into our existing pipeline to help visualize this progression. Beginning with our core generics. As you can see, we have either launched or have approval or have submitted some of significant products such as generics for Revlimid, Xarelto and Eliquis. We are targeting launching many of these core generics in the next 1 to 2 years. Flipping to the next slide. As you can see, we are continuing to move up the value chain with more complex products. Projected launch timings for many of these are in the next 2 to 4 years. What's unique about our complex generics pipeline is that it's primarily vertically integrated, giving us a much better control on the execution of these programs and R&D flexibility. You need to succeed and bring these products to the market. It also improves the margin profile of these products as we will no longer be sharing the profits. I'm very confident that like in the past, we are well-positioned to bring the first generic of many complex products to the market such as Symbicort, INVEGA TRINZA, Pentasa and Abilify long-acting injection. As I mentioned earlier, in the next 5 years, we also intend to invest in the life-cycle management of certain core products in our portfolio to meet unmet patient needs. We are already doing this for many products such as levothyroxine oral suspension, which we have submitted and expected regulatory action this year; glatiramer once monthly injection, builds upon our success with generic Copaxone. And we are completing the clinical phase of the development in remitting and relapsing multiple sclerosis. We have also initiated a Phase IV trial and are investing in the science around our Yupelri to explore the impact of revefenacin on a peak inspiratory flow rate and further expand the patient base. We are investing in the life-cycle management of our XULANE product and have initiated a Phase III study on a low-dose option. We have initiated a clinical study for EFFEXOR in Japan to extend the labeling for generalized anxiety disorder. And we are developing several new fixed dose combinations in cardiovascular for Chinese market. Finally, we are also developing meloxicam for rapid onset of postsurgical pain. We have submitted our IND and are now entering into our Phase II studies. As we enhance our R&D investments and put our capital to use, we look forward to further concentrating this pipeline around GI, ophthalmology and dermatology. Our pipeline, excluding biosimilars, that we shared with you today is well-positioned to deliver approximately $500 million plus in new product launches annually after '23. Our total pipeline is valued at $183 billion in IQVIA brand value. This broad pipeline also shows that we will cover almost 80% of the current top 100 IQVIA products, and it's more heavily weighted on complex products. I can hope, you can feel and appreciate the excitement and the confidence we have in our platform. Let's now pivot and discuss the business execution for the near term. While we reshape Viatris in the coming years, our business execution remains a top priority. I walked you through how we will reshape our portfolio and deliver the pipeline earlier. So now I'll provide an update on how we performed in '21, the progress on integration and how we expect to continue to further stabilize the business in '22. '21, we performed strongly as a team while we were creating a new company and navigating a dynamic environment. I truly appreciate and thank all of my colleagues around the world, who seamlessly executed a successful first year as Viatris. We made significant progress with our integration. We executed our restructuring program and achieved our target of approximately $500 million of cost synergies while already executing the Pfizer TSA exits for several programs. We delivered strong overall results, exceeding our expectations across all segments. In developed markets, Europe benefited from our thrombosis portfolio, as well as strong performance in key brands like Influvac, Lipitor and biosimilars. North America's base business performed as expected, despite unexpected competition in products like Miacalcin. Yupelri and EpiPen were other key contributors to the growth. We effectively manage the dynamics of the hospital channel in China while strongly growing the retail segment. Emerging markets responded to the challenge of providing the COVID-19-related products like remdesivir and AmBisome in several of their markets, which helped them offset the impact of changing therapy in antiretrovirals. Japan managed the Lyrica LOE exceedingly well, growing Amitiza and Lipacreon while leveraging the portfolio of authorized generics. On the pipeline front, we delivered on our commitment of approximately $700 million in new product revenue and significantly progress our robust pipeline of hard-to-make and complex products. Our science teams once again made us proud with the FDA approval and the launch of the first interchangeable biosimilar assembly to expand access for patients with diabetes. The strong performance across the globe was well supported by our global supply chain, which enabled us to achieve a record high customer service levels while navigating COVID-19. Let me speak on the integration path forward. We remain on track to realize an additional $500 million cost synergies over the next 2 years, resulting in $1 billion cumulative cost synergies since becoming Viatris. Our synergies in '21 were largely focused on actions around cost of goods, SG&A, cost widens and restructuring. And as planned, the remaining focus for our cost synergies in '22 and '23 is on the restructuring and exiting the remaining Pfizer TSAs. We have already completed a number of TSA exits through February of '22 and expect to exit the remaining TSAs by the end of the year. Let me now talk to you about '22. We are laser-focused to continue to further stabilize the business during this transition period. You will have this slide as a reference point, as I would like to move to the next one to review the headwinds and tailwinds in '22. We are well-positioned to build on the momentum of '21. And we will do this by delivering the approximately $600 million of new product launches, which I will talk about more on the next slide; driving growth in our key markets, including Europe, where we expect mid-single-digit growth; as well as China retail, where we continue to invest in the same. The key emerging markets like Turkey, Thailand, Mexico, Brazil and Korea are also expected to grow on the back of a more normalized market environment post COVID-19. Growing products such as Yupelri, Viagra, our Thrombosis portfolio, Creon, Amitiza and Dymista are also expected to grow in '22 and lend strength and stability to the business in the respective geographies; continued ramping up of our market share of interchangeable assembly to mid- to high teens in '22, and building off our successful launch; and by maintaining our leadership in Wixela and XULANE. At the same time, dynamic market conditions are an inherent part of our business. And our job is to perform in this ever-evolving environment. So '22 is going to be no different. We expect mid-single-digit pace business erosion in '22, largely driven by the continuation of increased competition in certain high-margin key products, like Perforomist and Miacalcin; continued implementation of China's health care policy; the changes in the anti-retroviral therapy guidelines, which we expect to continue to drive contraction of the market that has been stable or expanding over the last 10 years. We also expect total revenue to be negatively impacted by lower volumes for COVID-19-related products, mostly in our Emerging Markets segment. In '22, we'll also face the inflationary impact on input costs on manufacturing operations of our business. Going into more detail regarding our $600 million of expected new product launches in '22, of which about 1/3 is related to biosimilars. First, I'm excited to highlight that approximately 95% of our new product launches in '22 and '23 are already scientifically executed, meaning that they have been either already launched, approved or are pending approval. Interchangeable insulin glargine, Revlimid, Restasis, insulin aspart are a few key products in this bucket. So while we have not included Symbicort in our '22 financial guidance, we are happy with the progress on the product and remain ready to launch if the opportunity present itself in '22. While I won't go into great detail on the following segment slides, I'll hit on a few highlights. In developed markets, we expect low single-digit growth, primarily driven by strong performance of Europe. In Europe, we expect to continue to see strong growth, driven by our Thrombosis portfolio, Creon and Influvac, along with the robust new generic launches like Revlimid and Zytiga. In North America, our balanced portfolio of brands, complex generics, injectables and retail generics as well as our robust product launches will help us partially offset the inherent erosion in the market, as well as competition and lower EpiPen volumes coming off COVID-19 demand in '21. Yupelri will be the one of the key contributors to offset this. In emerging markets, we expect to see a year-over-year decline entirely driven by impact of lower COVID-19 product-related volumes. In JANZ, we expect strong volume growth from our key brands like Amitiza, Lipacreon and EFFEXOR, as well as continued success in building our authorized generics. We also expect common price regulations to have an increased impact, resulting in a high single-digit decline year-over-year. Our strong and well-established commercial presence in the hospital segment in China will support us as we continue to navigate the evolution of the health care policy. At the same time, we are confident in the macro drivers of China, supported by growth in the health care consumerism, and therefore are focused on continuing to expand our footprint in retail segment. To sum up, it's all about execution of our key priorities. We will complete the integration and realize remaining cost synergies. We will deliver the pipeline and expand our robust development house to move up the value chain, and we will continue further stabilizing the business. While we take actions to reshape the company, we'll close the biosimilar transaction in the second half of '22. We'll start working on the other identified divestment opportunities to continue to unlock value and simplify the portfolio. And more importantly, we'll continue leveraging the Global Healthcare Gateway to find value-creating business development opportunities. With this clear execution plan, we will create a simpler, stronger and more focused company of the future. Now I will turn it over to Sanjeev.
Sanjeev Narula: Thank you, Rajiv. We had another excellent quarter and closed out the year on a strong note. It's been incredibly successful first full year for Viatris, and I'm really pleased how 2 organizations have come together. Our strong financial performance demonstrate the breadth of our global platform. As I reflect on 2021, we delivered on our integration plan, met our financial commitment for deleveraging and dividend and developed a plan for bold strategic action to reshape our company going forward. Moving to Slide 53, we exceeded our November midpoint guidance and total revenue, adjusted EBITDA and free cash flow. Total revenue was driven by strong performance in developed market, which saw approximately 7% operational growth in Europe, which included the benefit of our thrombosis franchise. In North America, new product revenue was offset by anticipated base business erosion and competition in complex products. Taking these factors into account, generic price erosion was in line with our expectation. In JANZ, the impact from Celebrex and Lyrica LOE totaled approximately $600 million and now is largely behind us as we move into 2022. In Greater China, operational revenue was flat to the prior year as we continue to shift our business to the retail channel. Emerging market revenue was impacted by pressure on ARB business due to new treatment regimens, which were partially offset by the benefit of COVID-related products. Adjusted gross margin came in at 58.7% for the year, driven by strong brand performance and taking into account competition on key products in North America. In 2021, we were able to execute an accelerated integration time line, which allowed us to capture approximately $500 million in synergies across cost of goods sold and SG&A. Free cash flow benefited from underlying business performance, working capital optimization initiatives and low taxes. I'm pleased with the free cash flow generation for the year, which has enabled us to meet on our financial commitment. Slide 54 captures our reported financial results relative to the combined adjusted estimates for the prior year. Slide 55 identifies the driver of free cash flow for the quarter and full year. As we mentioned late last year, we anticipated Q4 2021 free cash flow to be impacted by several factors. These included timing of interest payment, higher CapEx and anticipated phasing of onetime cash costs. For full year, business performance, working capital benefits and lower cash taxes absorbed the higher onetime cash cost. These costs are expected to step down in 2022 and 2023 as we complete integration and restructuring activities. We delivered on our financial commitment and returned approximately $400 million in dividends and paid down over $2 billion in debt. Slide 56 captures key assumptions of the 2022 financial plan. The total revenue estimate assumes base business erosion to be in mid-single-digit range. Foreign exchange has a significant impact on results given our international exposure, which comprises approximately 70% of our total revenue. Key exposures include the euro and yen, with strong appreciation in the U.S. dollar over second half of 2021. And more recently, into 2022, our financial guidance incorporates approximately 2% headwind on the total revenue and adjusted EBITDA. We expect another strong year for new product revenue across a broad range of generic, complex and biosimilar products. In generics, we expect important launches, including Revlimid, Restasis and Sutent. In biosimilars, we are seeing solid uptake of interchangeable version of Semglee. Our guidance assumed a full year of biosimilar, which is approximately $875 million in total revenue and adjusted EBITDA of approximately $200 million. New product revenue includes approximately $200 million for biosimilars. Slide 57 captures our financial guidance ranges for total revenue, adjusted EBITDA and free cash flow and corresponding detailed line item metrics. Now turning to revenue build on Slide 58. This bridges the illustrated expected major drivers for 2022 relative to 2021 actuals. Removing the impact of foreign exchange. Our year-on-year total revenue is declining by approximately 2%. Base business erosion consists of 2 buckets. The first is approximately $200 million and is related to expected continued competition on key products, including Miacalcin and Performist. The second captures the expected erosion from price deterioration in North America generics, annual price reset across the Japan product portfolio and the continuing pressure on ARB business due to new treatment regimens and lower COVID-related products. In the base business, we expect strength across categories in Europe and higher volumes in China. Moving to Slide 59. We're expecting inflationary pressures across third-party supply chain for input cost, distribution and finished goods. We expect adjusted gross margin to be under slight pressure due to competition on key products and erosion of ARB volumes in emerging markets. Through our planned reshaping initiatives between now and 2026, we intend to invest more in R&D to drive our strategy and pipeline towards NCEs and 505(b)(2)s. On commercial side, our financial guidance reflect investment in some segments to build demand generation and in-market capabilities. Turning to Slide 60. We expect another strong year for free cash flow generation. Lower restructuring and integration costs will be partially offset by the impact of EpiPen litigation settlement. We expect to broaden implementation of working capital optimization initiatives in receivable and payable areas to continue to benefit us on free cash flow generation. Before I close, a few point on phasing. We expect total revenue and adjusted EBITDA to be slightly higher in the second half due to ramp of new products and normal product seasonality. We estimate free cash flow will be evenly weighted between first half and second half. In general, the second and fourth quarter tend to be lower due to timing of semiannual interest payments. In closing, we're coming off a strong year and well-positioned for a solid start in 2022. The estimated proceeds from the Biocon transactions, along with other reshaping initiatives are expected to strengthen the company and position us for a long-term success.
Michael Goettler: Thank you, Sanjeev. Thank you, Rajiv. As you can say, we're excited. Look, bottom line from today, what I really want you to take away from this, everything we presented today, is that the entire company, now that we laid out the strategy, the entire company, entire management team is focused on the future of Viatris. We're looking forward to build a company that's simpler, stronger, more focused, that has a portfolio consisting of generics, complex generics, off-patent brands and an increasing innovative growth engine of NCEs and 505(b)2s; a company that has significantly enhanced financial flexibility that we can put to use for either share repurchases and/or BD and R&D. And if you look at this, simply put, the years '22 and '23 are really years of execution, execution against the commitments that we've made for Phase I, the debt pay down, the dividend, the cash flow, the synergies, but also against now all the initiatives that we outlined to set ourselves up properly for success in 2024 and for many years beyond. That's what we're excited about. That's the vision we're laying out today. And with that, we're going to go to a short break. And after the break, we come back, and we look forward to your questions. Thank you.
A - William Szablewski: Good morning, everyone. Thank you for listening in to our investor event. We're going to move to the Q&A portion now. First question we're going to take, operator, is Chris Schott from JPMorgan. Thank you.
Christopher Schott: I just wanted to clarify the strategy a little bit in terms of what triggered this. Because it does seem like a bit of a departure from the broader portfolio you are creating with Upjohn. So can you talk a little bit about -- was this a financial decision? So when you look at where your stock is trading today, where valuations for some of these assets are, it just makes financial sense to do this? Or was this driven more about something you've seen from the company's performance or changes in the portfolio that you've experienced over the last year or 2? I'm trying to get a sense of a little bit more color on kind of what triggered this whole process. And the second one was more of a clarification on the valuation you're considering for the incremental $4 billion to $6 billion in asset divestitures. I think if I go back to Slide 15, it looks like there's $300 million to $500 million of EBITDA tied to these assets. I think that implies then a low double-digit EBITDA multiple on those products? Am I thinking about that valuation range properly? Is that the kind of the right ZIP code to think about for valuation there? So any color would be appreciated.
Michael Goettler: Chris, we missed the very beginning of your question. There was the sound was missing for about 30 seconds.
Christopher Schott: Let me repeat that then, if that works.
Michael Goettler: All right.
Christopher Schott: I was there I just wanting to clarify what triggered, I think, this departure -- this divestiture strategy. It seems like it's a bit of a departure from kind of the broader portfolio that was created with the original Upjohn-Mylan transaction. So I was just trying to figure out, is this a valuation-driven decision as you consider what some of these assets could be worth relative to where Viatris' stock is trading today? Or is this something that, as you look to the performance of the business and as you just had about a chance to understand some of these assets, that it's, I guess, more of a -- you see more of a need to focus in the portfolio? I'm just trying a little bit about how much of this is strategic versus how much of this is kind of opportunistic in terms of where valuations are.
Michael Goettler: Okay. Thank you, Chris, for that. Look, I think what we've done, as we promised to do is to do a comprehensive strategic review of all of our business, goes through -- and look bottom-up, and we took our time today with -- in 2021. We looked at all the portfolio that we have. Where we want to move to is very clear. We continue to be a broad-based business. We have generics. We have complex generics. We have off-patent brands. We want to add some innovative growth engine to it. Now as we looked at the biosimilar business, right, I think the deal recognizes the value of what we have created, the attractiveness of this business, because we think it is a very attractive valuation that we're getting. It's immediately unlocking value. It's giving us $2 billion immediately in cash up front. We continue to be involved in the biosimilar business just in a different way by having the 12.9%, at least 12.9% stake in the future Biocon Biologics, with the upside potential that comes with this. We created a company, and that's the strategic element here, that it's much better positioned for success by being vertically integrated. We said that's where we see the market going, and vertically integrated companies are going to be the champion of this. And there are multiple other benefits, including the unlocking of value and then being able to use that capital as well as the other divestitures to invest in the areas where we want to move, which is higher margin, more durable NCEs and 505(b)(2)s, in addition to the broad-based portfolio they already have. And I ask maybe Rajiv to give additional comments.
Rajiv Malik: Yes. No, I would say, Chris, anything I would characterize it, it's a continuation of the vision we had or the direction we had because long back we have said going up the value chain. So it's continuing on that path, number one. Number two, when you take a hard look, like let's say a couple of years back, when you start putting the assets together, you bring in organically, inorganically several assets. We took a hard look on some products. What products make sense? What products don't make sense? Now we took a hard look on our businesses. We are taking a hard look on the businesses. We are evaluating what are the must-haves as we go along, what fit in with the long-term strategy and maybe some other focus player has a more -- can put a more value to that. They are much better than somebody's else had. So I think this is how you're going to look into this, that we took time to look into each and every aspect of our business and said, okay, how can we unlock the value? And how can we reshape the company for future and set it up where it needs to go?
Sanjeev Narula: If I can just add, Michael. Chris, the other thing that you keep in mind, you talked about performance. We're actually coming from a position of strength. If you think about how we've performed, and including the results we announced earlier today, of 4 quarters of solid performance. And even without these reshaping initiatives, we are on track with our Phase I commitments that we talked about in terms of generating over $1 billion of free cash flow in 3 years. So it's actually coming from a position of strength and naturally evolving to where Rajiv and Michael just talked about is the next stage in our journey.
Michael Goettler: Right. And Chris, the second part of your question was on the additional assets. So obviously, we're not, at this point, disclosing what they are for reasons, for integrity of the process, for competitive reasons, et cetera. We'll disclose that as we come closer to it. But again, it's driven by the same motivation. It's either unlocking of value. It's a question of is it core and noncore for the future of our business going forward? And does it help us to simplify the business and reduce execution risk and complexity of the business that we have. That's the main motivation behind those assets as well. So I think with that, we'll take the next question.
William Szablewski: Yes. Thank you, Chris, for the question. Our next question, operator. We're going to go to Balaji from Barclays.
Balaji Prasad: A couple of questions for me. Firstly, on the guidance, as we look at 2022 guidance, I remember Rajiv, you had called out $6.2 billion as the floor in the last call? And that seems to be the higher end of the range now. So what's changed to have this delta and believe that this includes the biosimilars business as part of 2022. Second, as you look at the therapeutic areas that you've targeted for growth, can you give the current revenue and EBITDA size of these 3 therapeutic areas today? And what would you consider a successful build out by 2025 for these 3 therapeutic areas?
Michael Goettler: Okay. Let me maybe start with the question on EBITDA. Sanjeev laid out, I think, the moving pieces and where we land for 2022. 2023, really, we're not giving any targets at the moment because it wouldn't make sense with all the moving pieces, whether one of the business comes out in the middle of the year or end of the year can have a lot of changes, so we're not giving that. But what we did try to do is give you a vision for what would RemainCo look like after we're done with all of that. And again, that does not include any of the potential BD, any of the R&D we do, any of the share repurchase that we're going to play. So it's just a baseline business that we gave going forward. All eyes now really are on that future for us, right? And '22, '23 really should think about its execution years, continuing to being committed to our Phase I objectives of debt paydown, of dividend growth, of $8 billion in cash flow, of synergies, et cetera, we continue to be absolutely committed to that. But then really, it's about executing against the initiatives that we have laid out in 2022 and 2023 to build that future for Viatris '24 onwards and return this business to growth. That's what Viatris about. On the 3 therapeutic areas, look, we were very, very deliberate on how we picked those. And yes, we have some existing business in them. Sometimes it's from the generic business, sometimes it's from even a branded business that we can build upon. But we pick these areas because they really fit what we -- where we want to go in the future and what -- if you look at them, so what do they have in common, right? They are of a reasonable size. So you look at from ophthalmology to GI, you have market sizes between $27 billion and $56 billion. They are projected to grow in mid-single digits, 4%, 5%, 6%. They have multiple assets that are developed in Phase II and Phase III late-stage assets, the majority of which are developed not by large-cap pharma, but by mid- and small-cap pharma. So accessible to us, potentially through the Global Healthcare Gateway. You look at -- they're very specialist driven. So you don't need a very large primary care sales force to reach them. You can easily build, and we have already, in some cases, specialty sales force that can reach these doctors. They have high -- not high, but moderate probability of success, not low probability of technical success. They need smaller studies. They're not outcome driven. So you go through the list, they all have these common characteristics that we think make it fit very well to the platform that we have and the competitive set that we're going to have. Do you want to add anything?
Rajiv Malik: Yes, not just -- I would say, to your question, for example, GI, we have a pretty good franchises with Europe and some other markets, like Japan, Australia and all that. And Amitiza for Japan fits in, in the GI. And I think it's not about just how much size they have, it's the presence we have with those in that space. So I think that's been one of the considerations, as Michael very well pointed out. And same is the case of ophthalmology with the Xalatan knowledge we got from Upjohn. I think we have a pretty good understanding of that space commercially. So these are some of the factors, which we have taken into consideration while picking up these areas.
Michael Goettler: And the first deal that we just announced.
Rajiv Malik: Yes.
Michael Goettler: Yes.
Sanjeev Narula: Should I take the EBITDA?
Michael Goettler: Yes, please.
Sanjeev Narula: Right. So Balaji, on the EBITDA, I tried to explain that on Chart 59. So what's going on? There are 2 important factors that are not unique to Viatris, but that's the industry-wide. First is obviously foreign exchange. Our business is 70% international business. As you know, as seen second half of last year and beginning of this year, dollar has strengthened. Key currency that we have is euro and yen. So that all is causing at about a 2% headwind on our EBITDA and I showed that in the chart, that's about $120 million. So that's one factor. The second factor is the inflation on the input cost. This is on the third-party supply, whether it's the solvents, the -- all the third-party procured APIs, distribution cost, all that is causing an increase in the cost, which is again an industry-wide, and I tried to clarify that on the chart. That's about $196 million. So these factors, again, put together, is causing the -- have been considered in coming out of the guidance, where you see the midpoint is at $6 billion.
William Szablewski: Thank you. Next question, we're going to go to Elliot.
Elliot Wilbur: Just a first question for, Sanjeev, a point of clarification. Just wanted to confirm, in fact, that the contribution from the Biocon biosimilars business is, in fact, included for the full year of 2022 in terms of your EBITDA guidance. And then can you just give us a little bit of perspective in terms of sort of how to think about the evolution of all these onetime costs over the next couple of years? I guess that I would have expected more of a step down in 2022 than the roughly, I think, $1.4 billion that you talked about. Obviously, there's some legal settlements in there, but just wondering how to think about sort of the core of that and all these restructuring integration costs and how those may progress sort of beyond 2022? And then just lastly for Michael. I mean, certainly, the market, I think, is going to endorse your strategy of evolution to more of an NCE, 505(b)(2)-based strategy, while not necessarily maybe fully understanding sort of why you chose the therapeutic categories you did. But I guess the increasingly difficult part is to try and figure out sort of what kind of the new baseline is for the company in revenue and EBITDA. We've got all these moving parts now in terms of potential asset divestitures and the like. And if we want to and need to think about 2023 and beyond, I guess, it's just sort of difficult for us to think about like, okay, what is the year in which the company begins to grow? And what is that number from which the company can grow from? So anything you can say to help clarify that, I think, would be appreciated.
Michael Goettler: Sanjeev, you want to start?
Sanjeev Narula: Yes, sure. So Elliot, so first, for clarification, yes, the biosimilar EBITDA and revenues included in the guidance that we gave out today. And then as we pointed out, Rajiv pointed out, the transaction is expected to close in the fourth quarter towards the end part. So we're not expecting a big change in the numbers this year, but that is included in the guidance that we came out today. The second point that you talked about on the onetime costs, so we -- you do see a reduction in the onetime cost in 2022 as we issued on the guidance. So I think the way to think about, Elliot, in the guidance is we're now looking at onetime cost in actually 2 buckets. One is cost to achieve with all the restructuring and integration work that is going on. So that cost has actually come down in '22 and will come down -- will go down in '23 as we close out these initiatives. That cost is coming down, and that's part of the guidance. The other part of the cost, which is what we call it is cost in normal course of business, like the litigation settlements, profit shares, those kind of costs. Those will probably remain, move up and down, depending upon the situation of the year. And that's what you see because of the legal settlement, the cost is a little bit higher than reflected in 2022. So the big part, the cost to achieve, that has come down in '22, will continue to come down as we finish the restructuring initiative. The other cost, which is the -- all the other costs, which are required to run our business, would probably stabilize to the level that we have in this year's guidance.
Michael Goettler: Yes. And I think, look, on the longer-term outlook, clearly, Elliot, I mean, you caught it right, right? We want to move on the value chain. That's one of the ways we're going to return to growth, right? And that's the intent of what we try to do here. I think the best we can do right now is give you a pro forma that we laid out in the presentation, and Sanjeev walked through the proforma of what it would look like, after we're done with all the strategic initiatives. What we can't give you yet is what we're going to add to that, right? And our capital allocation priorities are clear. It's either going to go -- it's going to go to R&D, where we try to gradually ramp up our R&D. It's going to go to business development in the 3 therapeutic areas. And if you want offline, I can walk us through that more of why these are the ones that we think we particularly have a path to leadership in. Probably not all 3 of them, maybe only 1 of them, but these are the type of areas that we think we have a passive leadership on. So that part is missing, and you will see it evolving. Good news is, '22, '23 are the years of execution, is where we're going to deliver against that target, and we're going to -- you're going to see the initiatives that comes through. And then what I don't want to forget, Elliot, is also the share repurchases, right? That is clearly the bench and one of the important benchmarks. We now have significant financial flexibility to also do share repurchases. As you know, the Board has already authorized the $1 billion share repurchase program. It's going to be a significant factor for us going forward. And I would expect us, after we're done with the $6.5 billion share repurchase program, I'm not sure, $6.5 billion debt reduction, that we then move to an EPS model, right, because it would make sense with share repurchase having such an important element in our strategy going forward.
William Szablewski: Our next question, could we go to Jason from BOA?
Jason Gerberry: Just coming back on the divestitures. So I think it sounds like the plan would be to get rid of some of the lower-quality, low-margin businesses that at multiples that are well above the current blended company multiples. So I just wanted to confirm that. And where are you at in terms of the process with these divestitures? It sounds like in order to put out a slide deck like this, presumably, you guys are pretty far along to have gotten some line of sight that these valuation multiples are truly attainable. Just trying to get a sense if you have conviction in these numbers and these multiples? And then just on the EBITDA, if I could come back to that for a second. I guess the Street perceives you guys as guiding to beat based on last year. And so just trying to get a sense of conservatism because, yes, perhaps costs went up, but you had the opportunity to pull forward cost synergies. You've got the Restasis going one AG to compete against. So seemly you've got some benefits as well. So just curious if you can speak to some of the puts and takes to the upside there.
Michael Goettler: Okay. But Jason, on EBITDA guidance, as always, we take a balanced view of all the upsides and downside. We give you kind of realistic to where we think we're going to end. Maybe Sanjeev can give, talk a little bit more about the puts and takes. But Rajiv, do you want to talk about the divestitures a little bit more and the process we went through?
Rajiv Malik: Yes. No, we went to, as I told, pretty much a bottom-up process about what's core, what's not core, where the company is heading. And your point, some of these are not in line with our margins of the company, and some of these are those businesses the margin is not in that segment. And look, we -- the assumption was that once you focus on these assets, I would call them high-quality assets. So I'll say, once you focus, if they are in the player, if they are in the hands of who's focusing on that, there's a different value. And we did our work, and we are pretty much -- you're right, we are fairly -- we have not only identified, we have done some work to put that value over there. So we are pretty much on the way. And our goal is, we should be done with all this by end of '23.
Michael Goettler: And just to add, we added -- we also include external advisers to help us validate some of the numbers.
Rajiv Malik: Yes.
Michael Goettler: And make sure we got realistic multiples.
Rajiv Malik: That's very important, right.
Sanjeev Narula: And Jason, on the EBITDA, I think there's not much to add, except that I talked about those 2 factors, inflation and FX, that's industry-wide. I think the other thing, Jason, to keep in mind is the EBITDA guidance is the EBITDA guidance, and we -- Michael said that is very balanced in our view with the -- with our point to be meeting and exceeding that. I think the other factor that I want to highlight is the cash flow. We said we've been saying all along, the Phase I commitment is dependent on the cash flow, which is the North Star. We are still on track at these EBITDA levels, still planning to generate over $8 billion on the base business without any of the divestments you talked about that, which will be -- which is sufficient for us to meet our commitment for debt paydown and the dividend and dividend growth.
William Szablewski: Next question is going to be Ronny from Bernstein.
Aaron Gal: So I want to touch on 2 or 3 things. First of all, the baseline business. I'm aware that the generic business typically has its kind of a 5% erosion rate, but I was thinking that your international off-brand business is a lot more stable than that. Is the 5% you're giving us just a result to your projection for 2022? Or should we just think long term about that international business on existing products as facing a 5% erosion over time? And then second, you're kind of doing a kind of a big shuffle here, I was kind of under the impression that your strategy was. We have this global presence. We're just going to license products from companies and put that on that basis and that will be our strategy. And now you seem to be kind of shifting this to focus on specific 3 areas, one of which you would probably pick. Is that false strategy is simply not viable? Can we simply not take therapeutic-agnostic products and launch them globally using your infrastructure? And following up on that, you begin to talk about it why you're picking the products, the strategy, the area you're picking. Just for us who follow big pharma, those are hypercompetitive areas. Can you just tell us a little bit more granularity why -- where in those areas you're going to compete just because otherwise, you look like you're just competing with much larger companies with much bigger R&D budgets.
Michael Goettler: Rajiv, why don't you take the first question on the baseline of the erosion?
Rajiv Malik: Yes. Ronny, the blended -- if I say that if you put all the businesses together, that's where we are saying that blended erosion is around 4%, 5%. That's the 5% you are talking. And you're right, generics can
