Viatris Q4 2021 Earnings Call Transcript

There are 14 speakers on the call.

Operator

Good morning, everyone. I'm Bill Cieblewski, Global Head of Capital Markets for Viitris. It's my pleasure to welcome you to our investor event. With us today is our CEO, Michael Gettler our President, Rajeev Malik and our CFO, Sanjeev Nourla. We have a lot to share today regarding the reshaping of Viatris into a simpler, stronger and more focused company.

Operator

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 ks earlier today for a fuller explanation of those risks and uncertainties and the limits applicable to forward looking statements. We will be referring to certain actual and projected financial metrics of Viitris on an adjusted basis, which are non GAAP financial measures.

Operator

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. Viitris.com and in the appendix of today's slide presentation. The information discussed during the presentation, except for the participant questions, It's the property of Viitris and cannot be recorded or rebroadcast without Viitris' express written consent and permission.

Operator

An archived copy of today's presentation, along with a replay of the webcast will be available on our website at investor. Viatris.com, following the conclusion of today's event. With that, now I'd like to hand it over to our CEO, Michael Gettler. Thank you, Bill,

Speaker 1

And good morning and welcome to Viatoris 2022 Investor Event. This is truly an exciting day For all of us at Viatres, for our 37,000 colleagues around the world and for our shareholders. Not only I'll be 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 Beatrice. 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(2s).

Speaker 1

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 Viatrice that is simpler, that is stronger and that is more focused. The Viatrice that 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.

Speaker 1

And with today's announcement of the Biocon Biosimilar transaction, we've already taken the 1st 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. Viatoris 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 on our immediate priorities of integrating the 2 companies and delevering our balance sheet. And we wasted no time.

Speaker 1

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 $6,500,000,000 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.

Speaker 1

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 non core to the future of our company.

Speaker 1

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 Biocom 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.

Speaker 1

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 Viatoris a simpler, stronger and more focused company. In total, we expect these initiatives to generate up to $9,000,000,000 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.

Speaker 1

Our financial commitments for Phase 1, so that's the year 2021, 2022 and 2023, remain unchanged, pay down $6,500,000,000 in debt, Achieve $1,000,000,000 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 Director has already authorized a share repurchase program of up to $1,000,000,000 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(2)s.

Speaker 1

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 and 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 Healthcare Gateway. Now I'll explain further details on that strategy later, but for now, I would like to hand it over to Rajeev for further details on the Biocon biosimilar interaction, and I'll come back later. Rajeev?

Speaker 2

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 non core to the future direction of the company. These assets can generate up to Approximately $9,000,000,000 of pretax total proceeds. The plan is being executed as we speak. And up to $3,335,000,000 of these proceeds will come from the Plyacon transaction, which I will walk you through now.

Speaker 2

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 track value, we believe this evolution positions Biocon Biologics To further optimize and maximize the biosimilars business, Viatoris and Biocon started the journey together in 2,009 even before the biosimilars 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 the face of a mature market.

Speaker 2

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 we'll enable the new company to optimize end to end operational capabilities, serve market needs with competitive advantages And we'll have staying power. The transaction is subject to customary closing conditions, Including regulatory approvals, Viatris will receive total consideration of Up to $3,335,000,000 $3,000,000,000 of the consideration will be received immediately on closing With $2,000,000,000 in cash and $1,000,000,000 of convertible preferred shares, Viatris also expects to receive Tafford consideration up to $335,000,000 Beatrice 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 took commenced an IPO in India by late 'twenty 3. The deal consideration represents a transaction multiple of approximately 16.5x Based on estimated 'twenty two adjusted EBITDA of our biosimilar business of approximately $200,000,000 Under the terms of the agreement, Viatoris will contribute its biosimilar business, which includes All the programs currently partnered with the Biocon as well as our biosimilars program for Humira, Ambrell and Eylea, to facilitate a smooth commercial and operational transition, We will provide via a TSA select services such as commercial, regulatory and clinical.

Speaker 2

We will receive cost plus a markup of $44,000,000 annually for the duration of TSA. Now a bit on the share consideration. We will receive 1,000,000,000 dollars of the convertible preferred shares that represent a stake of at least 12.9% on a fully diluted basis. We believe Viatoris will be positioned to generate additional significant value Through the potential upside of our ownership stake in the combined business, an IPO in India It's targeted in late 'twenty three, and Viatris has a certain priority rights in an IPO. Viatoris will also receive customary anti dilution and preemptive rights.

Speaker 2

On Guarnas, Viatris will be granted 1 seat on the Board of Biocon Biologics. In terms of timing, While the transaction is subject to customary regulatory closing conditions, we currently expect the transaction to close In the second half of twenty twenty two, 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 Viatoris for the future. Now I will turn it over to Sanjeev.

Speaker 3

Thank you, Rajeev, 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 3,335,000,000 We've also announced a plan to reshape the company, which we expect to unlock additional value. In next few slides, I'll walk you through the reshaping Viatoris.

Speaker 3

How it strengthens our profile, accelerates financial flexibility and enhance our capital allocation framework. Slide 15 represents an illustrative pro form a for what Beatrice could look like post closing of Biocon Biologics transaction and after execution of plan Of the biosimilar business, the estimated 2022 biosimilar adjusted EBITDA margin is relatively lower compared to our company average. 2nd, looking at pro form a 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 $4,000,000,000 to $5,000,000,000 of after tax proceeds that will be deployed for investing into business and returning capital to shareholders.

Speaker 3

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 $500,000,000 With business development that is targeted towards assets that fit our strategic, commercial and financial criteria. These opportunities can come in form of regional tuck ins, a therapeutic focused pipeline and a broader distribution type arrangements Why our Global Healthcare Gateway? For profitability, we expect gross margins to stabilize over time given the focus on complex product that are wholly owned and not subject to partnership payments.

Speaker 3

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 and D investments. We expect SG and A to continue to benefit from synergies in 2022 And 2023, averaging route at approximately 20% of total revenue. And finally, upon closing of the Biocon transaction, Our balance sheet will be immediately strengthened with $2,000,000,000 in pretax proceed to accelerate our Phase 1 financial commitment. Now turning to Slide 17. We expect that the anticipated cash proceeds from Biocon transaction, along with the plan for other assets, We'll provide additional flexibility and enhance our capital allocation framework.

Speaker 3

Under Phase 1, we intend to accelerate the base plan by retiring short term debt in 20 In total, we intend to pay down at least $6,500,000,000 of debt between 'twenty one and 'twenty three in order to reduce our gross leverage We intend to increase R and 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 2.5 times to 3 times. 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

Speaker 1

Thank you, Sanjeev. Now as we said, we plan to expand our portfolio to more innovative And more durable assets such as NCEs and fiber hybrid IIs, and we will do that in a very focused way. And for this, we conducted a thorough analysis of our current We looked at the degree of unmet medical needs and the opportunity for innovation, availability of Phase II and Phase III late stage assets. We looked at who our competitors would be and who our prescribers are. And the results were clear.

Speaker 1

Some therapeutic areas had too much competition Or too much scientific risk for us to see 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.

Speaker 1

Next slide please. Viatris today already has a unique hybrid model With the requisite capabilities 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.

Speaker 1

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 1st Global Healthcare Gateway transaction focused on ophthalmology, acquiring an Nephritis affects about 6,500,000 patients in the U.

Speaker 1

S. Alone. And in the U. S, there's currently no product specifically indicated for chronic Nephritis. This product will contribute to ophthalmology franchise while we continue to search for an anchor asset.

Speaker 1

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 and 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 adds complementary growth assets in some of these therapeutic areas and then leverage the benefit of therapeutic area leadership And focus by leveraging the existing healthcare provider coverage, leveraging our existing development expertise, leveraging our existing medical expertise, leveraging the connections we have in the scientific community, etcetera. As I said, we see clear paths to therapeutically early leadership in 1 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.

Speaker 1

We have and are already executing on a clear path to reshape the entire company And build a durable higher margin portfolio consisting 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(2)s in our targeted therapeutic areas. And with this, we expect Viatris to have significant financial flexibility. In addition to debt pay down and dividend growth, We now expect to have the opportunity for increased R and 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.

Speaker 1

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 Rajeev now, who will be giving you more details on Our pipeline and how we're further enhancing that pipeline in line with our strategic vision. Thank you, Rajeev.

Speaker 2

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 and 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 health care gateway To further strengthen our R and 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.

Speaker 2

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 and D investments steadily to approximately 9% of revenue by 2026. This slide shows our road map to execute our R and 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.

Speaker 2

I'll walk you through certain examples in one of my following pipeline slides. We will seek additional inorganic assets through our global health care 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(2) novel products In the 3 focused therapeutic areas of GI, ophthalmology and dermatology, As Michael mentioned, in order to execute our R and 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.

Speaker 2

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 end 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 1, Phase 2, Phase 3 and Phase 4 studies.

Speaker 2

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 of 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 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.

Speaker 2

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.

Speaker 2

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 and 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 1st generic of many complex products to the market Such as SYMBICOT, INVEGA TRINZA, PENTESSA and EBILIFY 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 expect a regulatory action this year Biletramir once monthly injection builds upon our success with generic Copaxone.

Speaker 2

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 revifenesine on a peak inspiratory flow rate and further expand the patient pace. We are investing in the life cycle management of our Zulen product and have initiated a Phase III study on a low dose option. We have initiated clinical study for Effexor in Japan to extend the labeling for generalized anxiety disorder. And we are developing several new fixed doses combinations in cardiovascular for Chinese market.

Speaker 2

Finally, we are also developing meloxicam for rapid onset of postsurgical pain. We have submitted our IND and are now entering into our Phase As we enhance our R and 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, It's well positioned to deliver approximately $500,000,000 plus in new product launches annually after 23. Our total pipeline is valued at $183,000,000,000 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.

Speaker 2

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 delivered the pipeline earlier. So now I'll provide an update on how we performed in 'twenty one, the progress on Integration and how we expect to continue to further stabilize the business in 'twenty two.

Speaker 2

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 1st year As Viatoris, we made significant progress with our integration. We executed our restructuring program And achieved our target of approximately $500,000,000 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 ThermoSys 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 Myakelson, YUPELRI And EpiPen were other key contributors to the growth.

Speaker 2

We effectively managed The dynamics of the hospital channel in China while strongly growing the retail segment. Emerging Markets responded to the challenge of providing the COVID-nineteen related products Like remdesivir and embisome in several of their markets, which helped them offset the impact of Changing therapy in anti retrovirus. Japan managed the Lyrica LOE exceedingly well, Growing Amitiza and Depakrion while leveraging the portfolio of authorized generics. On the pipeline front, we delivered on our commitment of approximately $700,000,000 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-nineteen.

Speaker 2

Let me speak on the integration path forward. We remain on track to realize an additional $500,000,000 cost synergies over the next 2 years, resulting in $1,000,000,000 cumulative cost synergies since becoming Viatris. Our synergies in 'twenty one were largely focused on actions around cost of goods, SG and A, Cost widens and restructuring. And as planned, the remaining focus for our cost synergies in 2022 and 2023 It's on the restructuring and exiting the remaining Pfizer TSAs. We have already completed a number of TSA exits through February of 'twenty two and expect to exit the remaining TSAs by the end of the year.

Speaker 2

Let me now talk to you about 2022. We are Laser focused to continue to further stabilize 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 'twenty two. We are well positioned to build on the momentum of 'twenty one, and we will do this by Delivering the approximately $600,000,000 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. 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-nineteen.

Speaker 2

Growing products such as YUPELRI, Viagra, our Thrombosis portfolio, Creon, Amitiza And Demistra are also expected to grow in 'twenty two and lend strength and stability to the business in their respective geographies. Continued ramping up of our market share of interchangeable assembly to mid to high teens in 'twenty two, Building off our successful launch and by maintaining our leadership in Wixela and Zulen. At the same time, dynamic market conditions are an inherent part of our business, Our job is to perform in this ever evolving environment. So 'twenty two is going to be no different. We expect mid single digit base business erosion in 2022, largely driven by The continuation of increased competition in certain high margin key products like Performis and Mykelsen 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.

Speaker 2

We also expect total revenue to be negatively impacted by lower volumes for COVID-nineteen related products, Mostly in our Emerging Markets segment, in 'twenty two, we'll also face the inflationary impact on input costs on manufacturing operations of our business. Going into more detail regarding our $600,000,000 of expected new product launches in 'twenty two, of which about onethree is related to biosimilars. First, I'm excited to highlight That approximately 95% of our new product launches in 2022 and 2023 are already scientifically executed, Meaning that they have been either already launched, approved or are pending approval. Interchangeable insulin glargine, REVLIMID, RESTASIS, Insulin SPOT are a few key products in this bucket. So while we have not included Symbicort in our 'twenty two financial guidance, we are Happy with the progress on the product and remain ready to launch if the opportunity presents itself in 2022.

Speaker 2

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. 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 We'll help us partially offset the inherent erosion in the market as well as competition And lower EpiPen volumes coming off COVID-nineteen demand in 'twenty one. YUPELRI will be the one of the key contributors to offset this.

Speaker 2

In Emerging Markets, we expect to see a year over year decline entirely driven by impact of lower COVID-nineteen product related volumes. In Jansz, we expect strong volume growth from our key brands like Amitiza, Lipacrion and Effrexor 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, we'll 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.

Speaker 2

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 helps 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 'twenty two. We'll start working on the other identified divestment opportunities to continue to unlock value and simplify the portfolio.

Speaker 2

And more importantly, we'll continue leveraging the global health care 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.

Speaker 3

Thank you, Rajeev. We had another excellent quarter and closed out the year on a strong note. It's been incredibly successful 1st full year for Viatris, and I'm really pleased How two 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 a dividend and developed a plan for bold strategic action to reshape our company going forward.

Speaker 3

Moving to Slide 53. We exceeded our November midpoint guidance on 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.

Speaker 3

In Jans, The impact from Celebrex and Lyrica LOE totaled approximately $600,000,000 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 ARV 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 on accelerated integration timeline, which allowed us to capture approximately $500,000,000 in synergies across cost of goods sold in SG and A.

Speaker 3

Free cash flow benefited from underlying business performance, Working capital optimization initiatives and lower 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.

Speaker 3

These included timing of interest payment, higher CapEx and anticipated phasing of one time cash cost. For full year, business performance, working capital benefits and lower cash taxes absorbed the higher one time cash cost. These costs are expected to step down in 20222023 as we complete integration and restructuring activities. We delivered on our financial commitment and returned approximately $400,000,000 in dividends and paid down over $2,000,000,000 in debt. Slide 56 captures key assumptions of the 2022 financial plan.

Speaker 3

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 twenty twenty one and more recently into 2022, our financial guidance incorporates approximately 2% headwind On the total revenue and adjusted EBITDA.

Speaker 3

We expect another strong year for new product revenue across 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 Viatoris. Our guidance assume a full year of biosimilar, which is approximately $875,000,000 in total revenue and adjusted EBITDA of approximately $200,000,000 New product revenue includes approximately $200,000,000 for biosimilar. Slide 57 captures our financial guidance ranges for total revenue, adjusted EBITDA and free cash flow and corresponding detailed line item metrics.

Speaker 3

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 $200,000,000 And is related to expected continued competition on key products, including Myakhousein and Performist. The second captures Expected erosion from price deterioration in North America generics, annual price reset across the Japan product portfolio And the continuing pressure on ARV business due to new treatment regimens and lower COVID related products.

Speaker 3

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 3rd party supply chain for input costs, distribution and finished goods. We expect adjusted gross margin to be under slight pressure due to competition on key products and erosion of ARV volumes in emerging markets. Through our planned reshaping initiatives between now and 2026, we intend to invest more in R and D To drive our strategy and pipeline towards NCEs and 505(2s).

Speaker 3

On commercial side, our financial guidance 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 points 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.

Speaker 3

We estimate free cash flow will be evenly weighted between first We're coming off a strong year and well positioned for a solid start in 2022. The estimated proceeds from the Biocon transaction along with other reshaping initiatives are expected to strengthen the company and position us for a long term success.

Speaker 1

Thank you, Sanjeev. Thank you, Rajeev. As you can tell, 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, entire company, entire management team is focused on the future of Viatoris. 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 increasing Innovative growth engine of NCEs and 505(2s) a company that has significantly enhanced financial flexibility that we can put to use for either share repurchases And or BD and R and D.

Speaker 1

And if you look at this simply put, the years 202223 are really years of execution, execution against The commitments that we've made for Phase 1, 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.

Speaker 1

Thank you.

Operator

Good morning, everyone.

Speaker 4

I just want 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 were creating with Upjohn. So can you talk a little bit about was this a financial decision? So when you look at where Your stocks trading today, where evaluations 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 For changes in the portfolio that you've experienced over the last year or 2, I'm showing a sense of a little bit more color on kind of what triggered this whole process. And the second one is more of a clarification on the valuation you're considering for the incremental $4,000,000,000 to $6,000,000,000 in asset divestitures.

Speaker 4

I think if I go back to Slide 15, it looks like there's $300,000,000 to $500,000,000 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 right zip code to think about for

Speaker 1

Viatoris. Chris, we missed the very beginning of your question there. The sound was missing for about 30 seconds.

Speaker 4

Let me repeat that then, if that works. Sorry. So I was there just wanting to clarify what triggered, I think, this Departure or this divestiture strategy, it seems like it's a bit of a departure from kind of the broader portfolio Could be worth relative to where Viatris' stock is trading today? Or is this something that as you look at the performance of the business And as you just had a better chance to understand some of these assets that it's, I guess, more of a you see more of a need to focus on the portfolio. We're trying to little bit about how much of this Strategic versus how much of this is kind of opportunistic in terms of our valuations are?

Speaker 1

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, go 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.

Speaker 1

We continue to be a broad based business. We have generics. We have complex generics. We have Of patent brands, we want to add an innovative growth engine to it. Now as we looked at the biosimilar business, right, I think it's the deal recognizes The value of what we've created, the attractiveness of this business, because we think it is a very attractive valuation that we're getting.

Speaker 1

It's immediately unlocking value. It's giving us $2,000,000,000 Immediately in cash upfront, we continue to be involved in the biosimilar business just in a different way by having the 12.9%, at least 12.9 take in the future, Biocon Biologic with the upside potential that comes with this. We created a company and that's the strategic element here that 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.

Speaker 1

There are multiple other benefits, including the unlock more 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(2)s in addition to the broad based portfolio they already have. And I'll ask maybe Rajeev to give additional color.

Speaker 2

No, I would say, Chris, and 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 1. Number 2, 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 and inorganically several assets. We took a hard look on some products, What products make sense? What products don't make sense?

Speaker 2

Now we took a hard look on our businesses. We are taking a hard look on our 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 focused player has a more can put a more value to that. They are much Better in somebody's else hand.

Speaker 2

So I think this is how you're going to look into it is 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?

Speaker 3

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 performed and including the results we announced earlier today, our 4 quarters of solid performance And even without these reshaping initiatives, we are on track with our Phase 1 commitments that we talked about in terms of generating over $1,000,000,000 Of free cash flow in 3 years. So he's actually coming from a position of strength and naturally evolving to where Rajeev and Michael just talked about as the next stage in our journey.

Speaker 1

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, 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 Is it core or non core for the future of our business going forward?

Speaker 1

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 take the next question. Bill?

Operator

Thank you, Chris, for the question. Our next question, operator, we're going to go to Balaji from Barclays.

Speaker 2

Hi, good morning everyone.

Speaker 5

Couple of questions for me. Firstly, on the guidance, as I look at my incremental guidance, I remember Rajiv, you had called out 6 $200,000,000 was 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. 2nd, as you look at the therapeutic areas that you're targeted for growth, Can you give the current revenue and the EBITDA size for these 3 therapeutic areas today? And what would you consider A successful build out by 2025 for these 3 therapeutic carriers.

Speaker 5

Thank you.

Speaker 1

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 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 Remaincore 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 and D that we do, any of the share repurchase that we're going to plan.

Speaker 1

So it's just a baseline business that we gave going forward. All eyes now really are on that future for us, right? And 2022, 2023 really should think about its execution years, continuing to be committed to our Phase 1 objectives of debt pay down, of dividend growth, of $8,000,000,000 in cash flow, of Synergies, etcetera, we continue to be absolutely committed to that. But then really, it's about executing against the initiatives that we have laid out in 20222023 To build that future for Viatris 24 and onwards and return this business to growth. That's really what it's about.

Speaker 1

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 reasonable size.

Speaker 1

So you look at from ophthalmology to GI, you have market size of between $27,000,000,000 $56,000,000,000 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 Health Care 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.

Speaker 1

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. 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.

Speaker 1

You want to add anything?

Speaker 2

Yes. And I just I would say that to your question, for example, GI, we have a pretty good franchise as well as Europe and some other markets like Japan, Australia and all that and Amity is up where Japan fits in, in the GI. And that's it. It's not about just us, How much size they have? It's the presence we have with those in that space.

Speaker 2

So I think that's been one of the consideration, as Michael very well pointed out. And same as the case of Ophthalmology with the Xelatin knowledge we got from Upjohn, I think we have a pretty good understanding of that space commercially. So these are some of the factors we have taken into consideration while picking up these areas.

Speaker 1

And the first deal that we just announced.

Speaker 3

Should I take the EBITDA? Yes, please. All right. So Balaji, on the EBITDA, I tried to explain that on Chart 59. So what's going on?

Speaker 3

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, I've seen second half of last year and beginning of this year, dollar has strengthened. Key currency that we have is euro and yen.

Speaker 3

So that all is causing at about a 2% headwind on our EBITDA and I that in the chart. That's about $120,000,000 So that's one factor. The second factor is the inflation on the input cost. This is on the 3rd party supply, whether it's the solvents, All the 3rd party procured APIs, distribution costs, all that is causing an increase in the cost, which is again industry wide. And I try to clarify that on the chart.

Speaker 3

That's about $196,000,000 So these factors, again, put together, is causing the have been considered in coming out with the guidance where you see the midpoint is at $6,000,000,000

Speaker 1

Okay. Bill, next question please.

Operator

Thank you, guys. Next question, we're going to go to Elliot. Elliot, go ahead.

Speaker 6

Thanks. Good morning. Just first question for Sanjeev. 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.

Speaker 6

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 one time costs over the next Couple of years, I guess that I would have expected more of a step down in 2022 than roughly, I think $1,400,000,000 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 and 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(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?

Speaker 6

We've got all these moving parts now in terms of Potential asset divestitures and the like. And if we want to and You 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

Speaker 3

EBITDA and revenue is included in the guidance that we gave out today. And then as you pointed out, Rajeev pointed out, The transaction is expected to close in the Q4 towards the 8 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 one time cost. So you do see a reduction in the one time 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 one time cost in actually 2 buckets.

Speaker 3

1 is cost to achieve With all the restructuring and integration work that is going on, so that cost has actually come down in 2022 and will come down will go down in 2023 as we close out these initiatives. That cost is coming down and that's part of the guidance. The other part of the cost is which is what we call it is Cost in normal course of business like the litigation settlements, profit shares, those cut off 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 and reflected in 2022.

Speaker 3

So The big part, the cost to achieve, that has come down in 2022, 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 will probably stabilize to the level that we have in this year's guidance.

Speaker 1

Yes. And I think, look, on the longer term outlook, clearly, Elliot, You caught it right, right? We want to move up 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.

Speaker 1

I think the best we can do right now is give you a pro form a that we laid out in the presentation and Sanjeev walked through the pro form a, what it would look 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 We think we particularly have a path to leadership in. Probably not all three of them, maybe only one of them, but these are the type of areas That we think we have a past leadership on. So that part is missing and you will see it evolving.

Speaker 1

Good news is 2022, 2023 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 come through. And then what I don't want to forget, Ed, 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. You know, the Board has already authorized the $1,000,000,000 share repurchase program.

Speaker 1

It's going to be a significant factor for us going forward. And I would expect us, after we're done with the $6,500,000,000 Share repurchase program not share, this is about $5,000,000,000 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.

Operator

Okay. Next question, could we go to Jason from BOA?

Speaker 7

Thanks. Just coming back on the divestitures, so I think it sounds like that the plan would be to get rid of some of the lower 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 kind of get a sense of if you have Conviction in these numbers and these multiples.

Speaker 7

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 got the RESTASIS Boeing 1 AG to compete against. So seemingly, you got some benefits as well.

Speaker 7

So just Curious if you can speak to some of the puts and takes to the upside there. Thanks.

Speaker 1

Okay. But Jason, on EBITDA guidance, as always, we take a balanced view of all upsides and downsides will give you kind of realistically where we think we're going to land. Maybe Sanjeet can give talk

Operator

a little bit more about the puts

Speaker 1

and takes. But Rajiv, do you want to talk about

Operator

the divestitures a little bit more and the a little bit

Speaker 1

more on the process we went through.

Speaker 2

Yes. No, we went through, as I told, pretty much a bottom up process about What's core? What's non core? Where the company is heading? And your point, some of these are not in line with our margins of company and some of these are those businesses that the margin is not in that segment.

Speaker 2

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 out, if they are in the player, If they're 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 2023.

Speaker 1

And just to add, we added we also included external advisors to help us validate

Speaker 2

some

Speaker 1

of the numbers and make sure we got realistic multiples. That's very

Speaker 3

important. And Jason, on the EBITDA, I think there's not much to add except that I talked about those two 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 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 1 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 $8,000,000,000 on the base business without any of the divestments you talked about that, which will be Which is sufficient for us to meet our commitments for debt pay down and the dividend and dividend growth.

Speaker 3

Okay.

Operator

Next question is going to be Ronny from Bernstein.

Speaker 8

Hi, everybody, and So I want to touch on 2 or 3 First of all, the baseline business, I'm aware that the generic business typically has this 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 And as a result of your projection of 2022, 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 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 SMID companies and puts it on that basis and that will be our strategy.

Speaker 8

Now you seem to be kind of shifting this to focus on specific three areas, one of which you would probably pick. Is the Full 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 began to talk about it why you're picking the products, the strategies, the areas you're picking. Just for us who follow Bee Pharma, Those are hyper competitive areas.

Speaker 8

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 and D budgets.

Speaker 1

Ranit, why don't you take the first question on the baseline of the erosion?

Speaker 2

Yes. Ronnie, The blended, if I say that, if you put all the businesses together, that's where we are saying that blended ROI is around 4%, 5%, that's the 5% you're talking. And you're right, generics can have a component of 5%, 6% and the LOEs have Maybe 3% to 4%, not exactly at that level. And I'll tell you, I mean, I'm pleasantly surprised by how much we have been able to Hold it. And 1 year because of the and I'm not looking at this as an excuse.

Speaker 2

I think this is going to be a year when we are going out there In a normalized way, when our people can get out and all that. So there has been some movements over there. But I would say, Roughly, you should look into the brands at about 2%, 3%, 4%. Japan is a one key one where the price Eroian on these brands is a significant one, and we have that. So if you come out of the Japan and go to emerging markets and all It's not that much.

Speaker 2

So once we, I think, bottom out that, that's one piece. And the second one, you were Yes,

Speaker 1

the second was the Global Gatsby Gateway Before

Speaker 2

I go to even Gateway, I think, Ronny, we're not moving away from any business. I think if you see my slides over there on the R and D, We are still honing on and let's

Speaker 1

look at

Speaker 2

the generic space, 22, 23, 24, 25. We have some nice products lined up, Well, it's Symbicort, well, it's next year launching our this year launching Revlimid and then going into the complex injectable. So our investments From R and D, our loan of complex generics, but then more move on into the products like 505(2)s like COPAXONE is a good example, once a monthly. We just started study on the effects of GAD, general anxiety disorder. We started a study on YUPELRI, the preferred study, which is going to help us expand the patient pace.

Speaker 2

We started Three areas when they come in, I think when you look into the ANCs and all that, you can't be looking into therapeutic agnostic over there. That's where these three therapeutic areas come in. So Michael, you may want to

Speaker 1

No, I'll just echo what you said. I mean, Ronny, we're not walking away from anything here. There's absolutely we're going to be a company that's balanced, Right. That has a balance of generics, complex generics, off patent brands. And what we're willing to add now is this innovative, Higher margin, more durable portfolio.

Speaker 1

That's an end, that's an end, right? And if you do that, if you go in that innovative space, you have to do it in a focused way. You cannot build therapeutic area leadership by having being in 7 different therapeutic areas. You get benefits from having commonality of customers, Viatoris. That's the fly we were trying to build here.

Speaker 1

But as you saw in our slides, we also have still the opportunity for regional deals, Strengthening our portfolio, as Rajeev said, on the R and D side was, for example, the trial we're doing for generalized anxieties in order for FXOR in Japan, etcetera. So that opportunity still exists the opportunity for smaller licensing deals complementary to what Frodelet we have in the regions for even distribution deals. That opportunity still exists, but what we're adding today is that focus towards the higher margin products and then balancing that mix going forward for the future for the long term, after 24 many years. Okay. We'll have Bill next question.

Operator

Thanks, Ronnie, for the question. Next is going to be Eric from Evercore.

Speaker 9

Hi, this is Eric speaking. Thanks for taking my time and taking my question. Just a first one on EBITDA. I know we've talked about this a lot, but previously, Beatrice mentioned a $6,200,000,000 EBITDA floor. After this transaction for RemainCo, will that EBITDA be flat or growing over time?

Speaker 9

And then my second question, you mentioned at least 12.9 percent equity stake, which implies about a $7,700,000,000 valuation for Biocon Biologics. That's compared to like a $4,900,000 valuation from the stake sold to Serum Institute. So since it's at least 12.9%, does that mean there's room to renegotiate the size of that stake?

Speaker 1

Okay. Let me start with the EBITDA question, Eric, and I'll ask Rajiv to comment on the 12.9% evaluation question. On the EBITDA outlook, we're not giving we're giving you 2022 guidance. We're not giving long term guidance at the moment because Of all the moving pieces, and again, we gave you guidance of what Remaincore would look like, absent of any business development deals or other moves that we may be making. So I think That's what we put on the table now.

Speaker 1

Our intent is to move this company to the future beyond 2024, have returned to growth And make this durable higher margin portfolio. That's where we're shifting it. Where that growth comes in 24% or later at this point, I think it's too early to comment on. And Rajeev, you can maybe comment on the 12.9%.

Speaker 2

Yes. Eric, actually, let me just start by saying we are flattered by The value which has been assigned or which has been put on our biosimilar business by this partner or by this third party outside, Every deal, everybody has a different deal and we have our business. We know the value of our business. We know what we are walking into it. We are 1st of all, let's start with what's right for the business.

Speaker 2

We are setting up this company for success for a long time as a vertically integrated company. And we're going to be an equity holder in that company so that we can ride that upside and we can be with them To make them successful and then ride with them. It's value accretive at approximately triple of our current Stand alone multiples. Nearly twothree of our consideration in immediate cash Proceeds. So I can go on.

Speaker 2

I can go on. Like it frees up our R and D and capital deployment priorities. It frees up. We now can we are now free to go and apply where we are going and where we need to invest on. So immediate capital availability, Again, from the cash perspective, again, to if we need to invest back in the business or share buybacks and all that.

Speaker 2

So I will tell you, it's a great deal for us and we really feel Yes. It's a right logical step. We have set up the company in a right way. I know the space. I've been there now with Ever since the journey started in 2009, we have several learnings and we know what it would take to be successful in this space.

Speaker 2

I think this is the right call, and I'm very happy that I was a part of this journey and I'm part of this team to make this call.

Operator

Thanks, Eric, for the question. Next one, we're going to go to Nate at Goldman. Go ahead, Nate.

Speaker 10

Hi, good morning. Thanks for taking my question. I guess, I was just wanted to ask around the growth Outlook from new products, I guess, you said a $600,000,000 this year, I guess $100,000,000 of that's biosimilars. I think some of the key launches this year are also in the biosimilar space. So I guess, Moving forward, how do we think about like the cadence of revenue from new products?

Speaker 10

I think you had previously targeted kind of $600,000,000 to $700,000,000 How does that change as we think about the growth algorithm going forward given The biosimilar divestiture that you announced yesterday as well as the new kind of NTE strategy going forward? Thank you.

Speaker 2

Rajeev? So, Nate, the cadence should be we in one of my slides, last slides, had mentioned 500 plus $1,000,000 excluding biosimilar is this sort of cadence based on what do we have in the pipeline today. It doesn't take into consideration Us ramping up the R and D and us having the flexibility to add more into the R and D, investing more in the R and D, Investing more into the business, well print and doing those deals. So that's how you should see that.

Operator

Thank you, Nate, for the question. Next question, we're going to go to David Anson. Please go ahead.

Speaker 11

Thanks. So I wanted to get some more granularity regarding your thought process On R and D, I think the target is 9% by 2026. So How do you think about that target? I mean, and can you talk about How your thought process evolved here? In other words, what are some of the assumptions here?

Speaker 11

And I guess, Going forward, with this sort of focus or leaning into Brand assets, whether they're NMEs or 505(2) assets, do you have a target in mind in terms of portion of the mix, The product mix, the revenue mix that are brands, say, by 2025 or 2026. And how do you think about that? And then I guess the last piece is, with this brand focus, how much Internal R and D capabilities can you bring to bear in terms of these therapeutic verticals that you're focused on? Thanks.

Speaker 1

So I'll ask maybe the second question and then Rajeev, you can talk about the 9% R and D and how we get to that. But David, Look, I think what we have to realize that what we did today, what we're announcing today is a significant first step in unlocking value, Creating financial flexibility, laying out a clear capital allocation strategy going forward, where we're going to take that money, whether it's share repurchases, R and D or BD, In the BD and R and D area, being very focused, we want to move. I think that's about as much as we were comfortable communicating today, right? We have a 2 year runway to execute against that, And we'll take you along every step of the way as we go along. We don't have a fixed portion in mind necessarily going forward, but we know roughly which how much we need to do and why we want to rebalance the portfolio, and you'll see that as we execute over the next 2 years.

Speaker 1

And Balif, maybe you can comment on the 9%.

Speaker 2

Yes. I would say I will take a step back. Look, we have been investing $600,000,000 $700,000,000 on R and D circa, for last few years and every year we have been launching the products worth $600,000,000 $700,000,000 So it's pretty productive R and D machine, if I have to start from that. And as you see, 9%, it means we are doubling the R and D. We are going from about 600,700 to about 1,300,000,000, 1,400,000,000 Toward 26, we are doubling the R and D.

Speaker 2

And Ned, you should see as a development house where we have all the dosage form capabilities, clinical capabilities, Regulatory capabilities. And we have already executing on many 505(2) opportunities. So that's not an We partnered with TheraMance to execute YUPELRI. And we know that that's where the clinical capabilities we have and try to highlight on that, that how many Phase II, Phase III, Phase IV studies we have been part of. So I feel very confident that as we step up R and D, as we bring in the assets now, Late stage Phase II, Phase III asset, this machine is set up to execute and take us and help the Michael laid out the

Operator

Thanks for the question. Next question, we're going to go to Greg Fraser, Truist.

Speaker 8

Good morning, guys. Thanks for taking the questions. On the China business, what percentage of that business is retail and how much of the China sales do you expect the retail channel to account for over time? And you mentioned intensifying Competition in the retail channel, is that being driven by other multinationals or Chinese companies? And then just a follow-up on the additional asset sales that you're considering, are those sales likely to I mean, 1 or 2 larger deals or a series of smaller deals?

Speaker 8

Any color on that would be helpful. Thank you.

Operator

So again, I'll start

Speaker 1

with the second question. Rajeev, you can cover the China question.

Speaker 2

You go to the second first? You want to go for second or you want? So on China, Craig, you should see it as there are 3 segments. There's a public hospital segment. That's where the impact of this Health care policy is going to be fed.

Speaker 2

That's about 40%. That's going to be about 40% for us. Then there's a 45% sort of retail And then rest of it is some private hospitals. And that's where we are investing, that's where we are spending time, that's where we are expanding The footprint to so that we can offset what we basically going to face in the public hospital. So that's how you should these are the 3 Olivier, you should see in from China perspective.

Speaker 2

And yes, as you can anticipate, as focus has been on the retail, Healthcare consumerism, we're seeing both multinational as well as local Chinese companies stepping up the competition. But we have a There is still much quite a bit of appreciation for a global brand and the quality, and that's where we distinguish ourselves with many of those local companies.

Speaker 1

And Greg, on the assets, I mean, all I can tell you is it's a mix. There are several of them. It's not a single one. But I really don't want to disclose more at this point, again, to preserve the integrity of the process that we are running as well as for competitive reasons. And just like you saw with the Biocon deal,

Speaker 12

Hi, guys. Good morning and thanks for taking the questions. First, by divesting biosimilars, does that impact the rest of the Complex generic portfolio in any way by not having that combined offering for customers under the same roof. I'm curious how you think That dynamic is going to play out. And then Rajeev, I think you mentioned biosimilars are approaching a mature phase.

Speaker 12

Is that the case? I thought we were just sort of scratching the surface there in terms of biosimilars. How are you thinking about unlocking the value of that business now? And then maybe you could talk about the commercial execution with Semglee and Restasis, how quickly you've been able to get good coverage and penetrate those markets? Is this in line with expectations as we think of your ability to execute in those areas?

Speaker 12

And just in terms of the cash from the Biocon transaction, You're going to be deploying it in a bunch of ways. Just how committed are you to the dividend and growing that dividend as part of the overall mix? Thank you.

Speaker 1

Look, we continue to be committed to growing the dividend. We continue to be committed to returning value to shareholders. The Board has already authorized a $1,000,000,000 share repurchase program, and we continue to also be committed to investing in this company and growing it appropriately. And The trade off between all of these is a bit of a case by case thing. It's like as the opportunities come in, right?

Speaker 1

I mean, you see if you look at the PIM Economos deal that we just announced, it's a very creative We committed €40,000,000 upfront and have no scientific risk really and have an option at the back end. So continue to expect us to be creative here and be committed to Rajiv, if you want to comment on the other questions?

Speaker 2

Yes. I think the first question was about with biosimilar divestment impact our customer reach and all that. Greg, we are still very broad portfolio, very deep portfolio and more importantly, a deep pipeline. So yes, Couple of years from now, the biosimilars will not be a part of it, but we're going to continue to add more products so that we are meaningful. And like Always, like we have been for the last 2 decades, be a partner to our customers.

Speaker 2

So that focus is that not That focus and that importance of that aspect is not changing. As far as my comments about the maturity, the biosimilars How the market is evolving from the competitor landscape? Look at just HUMIRA. It's maybe one off, but there are 15 players out there. And Look into the just not U.

Speaker 2

S. As a market, Europe as a market where the tenders have gone to a point where you can be competing with the even brand At 80%, 90%, Erujian. So when I said it's heading towards or it's heading towards the face of maturity, I'm taking all that into consideration. And like we have managed In the last two decades, vertical integration helped us manage the similar environment in generics. That's what I saw.

Speaker 2

This is where exactly we are. And if we are looking 10 years ahead, this we need to be vertically integrated. And this was the Right next evolution right next, Paul.

Speaker 1

And that's why we're so excited about creating this vertically integrated biosimilar champion and staying Involved in it with at least 12.9% stake and being able to participate in the upside on that as well when the IPO happens. So we're thrilled about participating in the business In a better setup and in a different and more optimized way.

Speaker 2

And there was a question on insulin and rest assets. Yes. We are very much on track. We ended the year at about 4% on that. We are at about 10% TRx, NRx about 15%.

Speaker 2

We said we will be mid 15% to 20%, somewhere in between mid to high teens. That's where our this Your goal is and we are very much on the trajectory from the insulin point of view. And from the second, the stress is I cannot be more pleased. After a decade long Slugfest with all what we went through with the FDA. We were the first one to bring the product over there, very proud of the science team again.

Speaker 2

And Yes, there are products we don't see much competition over there. We have one Competitor over there as AG. So as long as we have that sort of space, we'll make most of it, and we are very much on track to beat meet our numbers on that one.

Operator

Thanks for the question. I think we have time for one more. Last question, I will go to Navan from Citi.

Speaker 13

Hi, good morning. Thanks for taking my questions. Could you go through the use and the breakdown of The SEK 3,300,000,000 proceeds in the near and medium term given that you have SEK 3,100,000,000 of bond maturities due This year and next, the €1,000,000,000 buyback and other uses of proceeds? And then just a second question for Rajeev. Could you describe your and Viatoris' involvement in Biocon Biologics in the future?

Speaker 1

Okay. Sanjeev, you want to take the question

Speaker 3

on that? Yes. So the Biocon deal It's immediately accretive and accelerates our Phase 1 commitment. So the $2,000,000,000 that we expect to get Post tax, to the Q4, we're going to utilize to pay down our short term maturity. We'll still have cash left at the end of the year And then obviously, additional cash next year.

Speaker 3

So all that would be available, as we talked about earlier, For potential business development or share buyback, both options would be there. And then we'll evaluate case by case situation at that time, Way to go for one way or the other or both? So that's the overall. And then when the proceeds come from the IPO, which is earliest Q3, 20 24 23 or Q24 beginning. Again, that adds to the flexibility about what we talked about in terms of whether that's going to be BD tuck in deals or more share buybacks.

Speaker 3

So that's kind of the thing. But immediately, the $2,000,000,000 will add to our and accelerate our Phase 1 commitments And provide an additional cash for share buyback or BD.

Speaker 2

And Johan, Let's just say it's a very complementary deal. We have a huge responsibility for the next 2 years. We're going to Help my role will be to help it integrate it in seamless way, bring these businesses execute for next 2 years. Nothing should come in the way. And then when you are getting into 'twenty four, 'twenty five, make sure how seamlessly we can transfer these capabilities and resources, Set up the new company for success, help them in every possible way as you'd expect us to be doing it for the long term perspective as we are A meaningful stakeholder in that company.

Speaker 2

So I'll do everything in my everything possible in my way to help that.

Speaker 1

Okay. All right, Nelan, thank you for that question. As I said at the very beginning of today, this is an exciting day for Beatrice, an exciting day For our employees, it's an exciting day for shareholders. I think we've laid out for you a very clear path going forward. 2021 really was the year We delivered against the targets we set, we integrated, we synergized, we brought the 2 companies together, but we also used that time to really lay out, do a thorough Used to return value to shareholders and or invest in our business.

Speaker 1

We clearly laid out to you what we're going to do in R and D. We try to lay out to you in BD, which The solid core that we have with generics, complex generics and off patent brands. We're excited about the future and we look forward to keeping you updated as we deliver value to shareholders and provide access to patients. Thank you.

Earnings Conference Call
Viatris Q4 2021
00:00 / 00:00