Viatris (VTRS) 10-K risk factor changes: FY2021 vs FY2020
The 2021-12-31 10-K against the 2020-12-31 one, compared heading by heading and sentence by sentence.
Item 1A118 rewritten73 added49 removed627 unchanged
All filing items1,324 rewritten596 added829 removed2,746 unchanged
Summary
counted, not written
- Item 1A lists 47 risk factor headings: 4 new, 2 reworded and 41 unchanged since FY2020. 1 heading from FY2020 no longer appears.
- Sentence by sentence, 596 added, 829 removed, 1,324 rewritten and 2,746 unchanged across 15 items that differ.
- New this year: Item 4. Mine Safety Disclosures; Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
New Item 1A headings (4)
- There are risks and uncertainties associated with the pending transaction involving our biosimilars business, one or more of which could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or stock price.
- Our business and operations are subject to risks related to climate change.
- There can be no guarantee that we will continue to pay dividends or that we will implement repurchases under our stock buyback program.
- Our business and operations could be negatively affected by pressures from outside of the control of the company, including, but not limited to, shareholder actions, government regulations and disclosure requirements, and other market dynamics, which could cause us to incur significant expenses, hinder execution of our business strategy and negatively impact our share price.
Removed Item 1A headings (1)
- Viatris’ future dividend payments cannot be guaranteed.
Reworded Item 1A headings (2)
- The illegal distribution and sale by third parties of counterfeit [added: or IP-infringing] versions of our products or of diverted or stolen products could have a negative impact on our reputation and our business.
- Increasing scrutiny and evolving expectations from customers, regulators, investors, [added: employees,] and other stakeholders with respect to our environmental, social and governance practices may impose additional costs on us or expose us to new or additional risks.
A heading is new when no FY2020 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
22 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2021; struck-through words were in FY2020. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. Risk Factors
118 rewritten, 73 added, 49 removed, 627 unchanged
- challenges in reducing reliance on certain transition services provided by [removed: Pfizer] [added: Pfizer, including difficulty hiring employees or finding other suitable replacements and managing the amounts of related replacement costs,] prior to the expiration of any period in which such services are provided; and
In addition to integration activities with respect to Mylan and the Upjohn Business, [removed: on November 16, 2020,] Viatris [removed: announced] [added: is also implementing] a significant global restructuring program in order to achieve specified synergies [removed: over the next four years, or sooner,] and ensure the new company is optimally structured and efficiently resourced to deliver sustainable value to patients, shareholders, customers, and other stakeholders.
Even if the integration and [added: global] restructuring program are successful, we may not achieve these synergies, growth opportunities and other financial and operating benefits within the timeline we anticipate, or at all.
[added: For] example, the benefits from the Combination may be offset by significant costs incurred in connection with our global restructuring program and the Combination, including integration and post-closing costs, costs associated with our TSAs with Pfizer, and capital expenditures, which could be higher than currently estimated.
In connection with the Combination, Pfizer received the IRS Ruling and the Tax Opinion, each to the effect that, for U.S. federal income tax purposes, the Distribution, together with certain related transactions, will qualify as a tax-free “reorganization” within the meaning of Section 368(a)(1)(D) of the Code, the Distribution will qualify as a tax-free distribution [added: within the meaning of Section 355 of the Code and the Pfizer Distribution Payments will qualify as money distributed to Pfizer creditors or stockholders in connection with the reorganization for purposes of Section 361(b) of the Code.]
For this purpose, any acquisitions of Pfizer or Viatris common stock within the period beginning two years before the Distribution and ending two years after the Distribution [added: (i.e., on November 16, 2022)] are presumed to be part of such a plan, although Pfizer may be able to rebut that presumption.
Furthermore, unless an exception applies, for a two-year period following the date of the [removed: Distribution,] [added: Distribution (i.e., until November 16, 2022),] Viatris and its subsidiaries may not:
If Viatris intends to take certain restricted [removed: actions,] [added: actions before November 16, 2022,] it must notify Pfizer of the proposal to take such action and either (a) obtain a ruling from the IRS or an unqualified opinion acceptable to Pfizer to the effect that such action will not affect the tax-free status of the Distribution and certain related transactions or (b) receive from Pfizer a waiver of such requirement.
In addition to the integration and restructuring activities [added: and the Biocon Biologics Transaction, each of which is] discussed above, we have entered into and continue to consider and evaluate various strategic transactions and business arrangements on an ongoing basis, including acquisitions, asset purchases, partnerships, collaborations, joint ventures, divestitures, product rationalization and investments.
We have also entered into strategic alliances with [removed: partners] [added: partners, including through our Global Healthcare Gateway®,] to develop, manufacture, market and/or distribute certain products, and/or certain components of our products, in various markets.
In addition, our Global Healthcare [removed: Gateway] [added: Gateway®] may not achieve all of its expected benefits.
The overall execution of a strategic initiative may result in material unanticipated problems, expenses, liabilities, competitive responses, [added: operational inefficiencies, adverse tax consequences,] loss of customer relationships, [added: difficulty attracting] and [added: retaining qualified employees, and] diversion of management’s and/or employee’s attention, among other potential adverse consequences.
As a result, we face numerous cost-containment measures by governments and other payors, including certain government-imposed industry-wide price reductions, mandatory rebates or pricing, international reference pricing (i.e., the practice of a country linking its regulated medicine prices to those of other countries), volume-based procurement, tender systems, shifting of the payment burden to patients through higher co-payments, and requirements for increased transparency on [removed: pricing.][added: pricing, all of which may have an adverse impact on the pricing of our products.]
Many markets in which we operate have implemented or may implement tender systems for generic [added: and biosimilar] pharmaceuticals in an effort to lower prices.
[removed: The] [added: While criteria other than price can be included in tenders,] tender [removed: system] [added: systems] often [added: select the lowest bid, which often] results in companies underbidding one another by proposing low pricing in order to win the tender.
Other markets may also consider the implementation of a tender [added: system, and even if a tender] system or [removed: have implemented, or plan to implement, government mandated price reductions and/or] other [removed: forms] [added: price controls are ultimately not implemented, the anticipation] of [added: such could result in] price [removed: controls.][added: reductions.]
In addition, VBP policy for post- LOE products is now in its [removed: third] [added: fourth] year and includes more than [removed: 150] [added: 200] molecules.
We expect pricing pressures on our products included in the VBP program to continue to increase as a result of these [removed: programs, and Viatris may be unable to successfully win contracts through these centralized procurement projects in the future.][added: programs.]
We have failed, and may continue to fail, to win bids due to various factors, including [added: uncompetitive bidding prices.]
There has also been increasing U.S. federal and state legislative and enforcement interest with respect to drug pricing, as well as from international organizations like the United Nations, [removed: World Health Organization] [added: WHO] and Organization for Economic Cooperation and Development, in addition to intense publicity and scrutiny regarding such matters, including publicity and pressure resulting from prices charged by competitors and peer companies for new products as well as price increases by competitors and peer companies on older products that some have deemed excessive.
In addition, there have been [removed: legislation] [added: executive orders, legislation,] and legislative and regulatory [removed: proposals] [added: proposals, including in connection with government programs such as Medicare,] concerning drug prices and related issues, including the perceived need to bring more transparency to drug pricing, reviewing the relationship between pricing and manufacturer patient programs, and reforming government program reimbursement methodologies for drugs.
Although we expect to see continued focus in regulating pricing, we cannot predict what, if any, additional legislative or regulatory developments may transpire at the state or country level, [removed: particularly given a new administration and changes in control of Congress,] or what the ultimate impact may be.
The [removed: international patchwork of price regulation,] [added: numerous cost-containment measures by governments and other payors,] failing to win tenders, the implementation of price control systems, adverse legislation and regulation, the consolidation of our customers, or continued social or government pressure to lower the cost of pharmaceutical products could have a material adverse impact on our business, reputation, financial condition, results of operations, cash flows, ability to pay dividends and/or stock price.
Further, Congress continues to consider drug pricing legislation that, if passed and signed into law, could impact companies’ ability to increase prices for products beyond the rate of [removed: inflation.][added: inflation, and could allow Medicare to negotiate prices on a subset of brand drugs.]
The ACA and further changes in the law or regulatory framework that reduce our revenues or increase our [added: costs could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends and/or stock price.]
[removed: costs] [added: Any of the risks described above] could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends and/or stock price.
In the [removed: EU] [added: EU, U.K.] and some other international markets, the government provides healthcare at low cost to consumers and regulates pharmaceutical prices, patient eligibility and/or reimbursement levels to control costs for the government-sponsored healthcare system.
Significant additional reforms to the U.S. [removed: or EU] healthcare [removed: systems,] [added: system,] or to the healthcare systems of other markets in which we operate, could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends and/or stock price.
- compliance with the national and local laws, regulations and customs of countries in which we do business, including, but not limited to, data privacy and protection, [added: environmental and social regulations,] import/export and enforcement of intellectual property protections;
- compliance with a variety of U.S. laws including, but not limited to, [added: trade controls or sanctions,] regulations put forth by the U.S. Treasury’s Office of Foreign Assets Control, the Iran Threat Reduction and Syria Human Rights Act of 2012 and rules relating to the use of certain “conflict minerals” under Section 1502 of the Dodd-Frank Wall Street Reform and the Consumer Protection Act;
- increased [removed: U.S. Congressional] [added: EU] and [removed: executive branch] [added: U.S.] scrutiny of overseas pharmaceutical manufacturing, including executive orders and policy proposals related to increasing [removed: U.S.] [added: domestic] production of pharmaceutical products and API;
- changes in employment or labor laws, [removed: wage increases,] or [removed: rising inflation] [added: wage increases] in the countries in which we or our partners and suppliers operate;
- [removed: risks and uncertainties related to] [added: changes resulting from] the formal withdrawal of the U.K. from the EU, commonly referred to as Brexit, [removed: and the subsequent entry into a trade agreement that governs the U.K.’s relationship with the EU,] including [removed: with respect] [added: those related] to [removed: divergent national laws and regulations, import/export restrictions, delays in regulatory approvals] [added: additional trade agreements, tariffs] and [removed: changes in pharmaceutical] [added: customs] regulations [removed: governing marketing authorizations in the EU] and [removed: the U.K.,] [added: currency fluctuations,] which could materially impact the way we conduct our operations in those markets;
- burdens to comply with multiple, changing and potentially conflicting [removed: foreign laws] [added: laws, regulations] and [removed: regulations,] [added: disclosure requirements,] including those relating to [removed: the environment,] [added: environmental, social and governance matters,] carbon emissions, health and safety, labor and human rights;
The illegal distribution and sale by third parties of counterfeit [added: or IP-infringing] versions of our products or of diverted or stolen products could have a negative impact on our reputation and our business.
The pharmaceutical drug supply has been increasingly challenged by the vulnerability of distribution channels to illegal counterfeiting and the presence of counterfeit [added: or IP-infringing] products in a growing number of markets and [added: widespread] over the internet.
Third parties may illegally distribute and sell counterfeit [added: or IP-infringing] versions of our products that do not meet our rigorous manufacturing and testing standards.
Counterfeit medicines may contain harmful substances, the wrong [added: API, an incorrect] dose of API or no API at [removed: all.][added: all, depriving patients of the therapeutic benefit of such medicines.]
Reports of adverse reactions to counterfeit [added: or IP-infringing] drugs or increased levels of counterfeiting could materially affect patient confidence in the authentic product.
We also face increasing competition from lower-cost generic products and other branded [added: products, including our ARV] products.
◦The risks and uncertainties associated with the pending transaction involving our biosimilars business.
◦Our future success is highly dependent on our ability to attract, motivate and retain key personnel.
◦There can be no guarantee that we will continue to pay dividends or that we will implement a stock buyback program.
As of December 31, 2021, the Company has incurred approximately $83.5 million of such expenses.
There are risks and uncertainties associated with the pending transaction involving our biosimilars business, one or more of which could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or stock price.
There are a number of risks and uncertainties associated with the pending Biocon Biologics Transaction, including, among other things, the potential failure of a condition to closing, including the conditions related to obtaining required regulatory and other consents and approvals, which could give rise to the termination of Biocon Agreement and related agreements executed between us, Biocon and Biocon Biologics, as applicable.
Either party has the right to terminate the Biocon Agreement if the closing has not occurred by March 31, 2023, subject to extension in certain circumstances.
For example, a failure by Biocon Biologics to obtain necessary financing to consummate the transactions contemplated by the Biocon Agreement prior to such date could cause the Biocon Agreement to be terminated.
To the extent that the current market price of our common stock reflects an assumption that the transactions contemplated by the Biocon Agreement and related agreements will be consummated in the timeframe and manner currently anticipated, and that a portion of the proceeds to us will be used to pay down debt and/or to fund other important company initiatives, any delay in closing or failure to close could result in a decline in the market price of our common stock.
Similarly, any delay in closing or failure to close could result in damage to our relationships with customers, suppliers and employees, including our existing relationships with Biocon and Biocon Biologics, and have an adverse effect on our business.
Pending the completion of the transactions contemplated by the Biocon Agreement, the attention of our management may be directed toward such transactions and related matters, and their focus may be diverted from the day-to-day business operations of our company, including from other opportunities that might otherwise be beneficial to us.
We have agreed to indemnify Biocon Biologics and certain of its representatives against certain losses suffered as a result of certain breaches of our representations, warranties, covenants and agreements in the Biocon Agreement and related documents.
Any event that results in a right for Biocon Biologics to seek indemnity from us could result in substantial liability to us and could adversely affect our financial position and results of operations.
In addition, in connection with the closing of the pending transaction with Biocon Biologics, we will enter into a transition services agreement pursuant to which we will provide services to Biocon Biologics, including commercialization services substantially the same as we currently provide to our biosimilar business, generally for a period of up to two years.
Once in effect, our obligations under the transition services agreement may result in additional expenses that are borne by us and may divert our focus and resources that would otherwise be invested into maintaining or growing our retained business.
Furthermore, a significant portion of the consideration that we will receive in the pending transaction with Biocon will be in the form of equity in Biocon Biologics, which is a privately held Indian company.
Although we have negotiated certain “downside” protection regarding the value of that equity in the Biocon Agreement and related documents, such protection does not guarantee any particular liquidity event or our ability to monetize our equity and, even if we are able to successfully liquidate our equity, the downside protection may be inadequate to guarantee a minimum return that we or investors expect.
In addition, we believe the success of the Biocon biologics business over at least the first two years after closing, will be highly dependent upon the successful transition of the business to Biocon, including no major disruption in services provided under the transition services agreement, which will also have a significant impact on the value of the equity we will own in Biocon Biologics.
Whether the Biocon Biologics transaction is ultimately consummated or not, the pendency could have a number of negative effects on our current business, including potentially disrupting our regular operations, diverting the attention of our workforce and management team, and increasing workforce turnover.
It could also disrupt existing business relationships, make it harder to develop new business relationships, or otherwise negatively impact the way that we operate the business, which could negatively impact Viatris’ results of operations and cash flows during the pendency of the transaction.
If we successfully complete the pending transaction involving our biosimilars business, our total revenues, results of operations and cash flows from operating activities are expected to be negatively impacted in the periods after close.
We have expended significant time and resources, and expect to continue to expend significant time and resources, on the transaction involving our biosimilars business, including management time and focus, costs and expenses related to the separation of the biosimilars business from Viatris, the provision of the transition services and other transaction costs.
Many of these expenses must be paid regardless of whether the transaction closes, and even if the expected benefits are not achieved.
We may also face other challenges as a result of the announcement and completion of the transactions contemplated by the Biocon Agreement, including that we may not be able to realize the anticipated benefits from such transactions, such as deploying the proceeds to pay down our outstanding indebtedness and/or fund other important initiatives, and maintaining employee morale and retaining key management and other employees to provide the transition services and to operate our retained business.
We may miscalculate the risks associated with our strategic initiatives, including business development transactions, at the time they are made or not have the resources or ability to access all the relevant information to evaluate them properly, including with regard to the potential of R&D pipelines, manufacturing issues, compliance issues, or the outcome of ongoing legal and other proceedings.
Furthermore, divestitures, product rationalizations or asset sales could result in decreased total revenues, results of operations and cash flows from operating activities in future periods, reduce the size or scope of our business, our market share in particular markets or our opportunities and ability to compete with respect to certain markets, therapeutic areas or products.
In addition, should we seek to divest other of our assets and business, we may be unable to dispose of such businesses and assets on satisfactory or commercially reasonable terms or within our anticipated timeline, in part because of competition from other companies in pursuing similar transactions in the pharmaceutical industry.
In addition to the impacts of these government-sponsored healthcare systems, in the EU, U.K. and other international markets, certain governmental agencies have or are considering enacting further measures to decrease the costs of providing healthcare, including government mandated price reductions and/or other forms of price controls, including retrospective “clawback” price reductions.
as a result of the COVID-19 pandemic and the changing healthcare landscape in those markets.
- increased trade controls or sanctions as a result of the escalation of tensions between Russia and Ukraine that may affect our ability to market or sell pharmaceuticals in either country;
In many emerging markets, we face increased competition and contracting markets for certain of our ARV products, primarily related to competing therapies.
The increase in the concentration of our top product sales in 2021 was primarily driven by the impact of the Combination.
In addition, recovery from the pandemic may not proceed as anticipated, and may have unpredictable impacts on demand for our products, our workforce and our business operations.
All of these factors could have a material adverse impact on our workforce, business operations, financial condition, results of operations, cash flows and/or stock price and may impact our ability to pay dividends.
In addition, some of our customer-facing field personnel continue to operate on a remote engagement model to ensure continued support for healthcare professionals, patient care and access to needed products.
The FDA and comparable foreign regulatory agencies may have slower response times or reduced resources and, as a result, review of regulatory submissions, inspections, approval of
In addition, accelerating rates of inflation are expected to continue in the near future and have resulted, and may continue to result, in increased costs of labor, raw materials, other supplies and freight and distribution costs, among others.
For the pharmaceutical industry and the healthcare systems in the markets in which we participate, the pricing dynamics of our products generally does not provide the opportunity to pass on such costs to customers.
Inflation may also result in higher interest rates and increased costs of capital.
We may be required to expend significant funds and our
◦The development, approval process, manufacture and commercialization of biosimilar products involve unique challenges and uncertainties, and our failure to successfully introduce biosimilar products could have a negative impact on our business and future operating results.
◦Viatris’ future dividend payments cannot be guaranteed.
This Viatris restructuring program incorporates and expands upon a prior Mylan restructuring program.
On December 11, 2020 and February 25, 2021, Viatris disclosed additional details related to this global restructuring program that may impact up to 20% of its global workforce and includes the closing, downsizing or divesting of up to 15 manufacturing facilities.
For
within the meaning of Section 355 of the Code and the Pfizer Distribution Payments will qualify as money distributed to Pfizer creditors or stockholders in connection with the reorganization for purposes of Section 361(b) of the Code.
Furthermore, although our expectation is to engage in divestitures and product rationalizations only if they advance or otherwise support our overall strategy, any such sale could reduce the size or scope of our business, our market share in particular markets or our opportunities with respect to certain markets or products.
This international patchwork of price regulation and differing economic conditions and incomplete value assessments across countries has led to varying access to quality medicine in many markets and some third party trade in our products between countries and may have an adverse impact on the pricing of our products.
Even if a tender system or other price controls are ultimately not implemented, the anticipation of such could result in price reductions.
While all major Viatris brands are already included in the VBP molecule list, historically we have had limited success in the bidding process and most contracts went to local Chinese generic companies.
uncompetitive bidding prices.
In particular, U.S. federal prosecutors have issued subpoenas to pharmaceutical companies, including Mylan, seeking information about their drug pricing practices, among other issues.
The U.S. Congress has also conducted hearings with respect to drug pricing and members of Congress have sought information from certain pharmaceutical companies, including Mylan, relating to drug-price increases.
In the U.S., in addition to new state transparency laws and the introduction of several federal pricing bills, several executive orders were signed and rules were issued in 2020 relating to drug pricing, some of which have been delayed and/or are the subject of litigation.
These new orders and rules related to Medicare Part D rebate reform, providing discounted insulin and/or EpiPen® Auto-Injector to patients in Federally Qualified Health Centers, drug importation from Canada, and most favored nation pricing for Medicare.
In the future, we expect that the mix of our top products will change and the concentration of sales for those top products will increase as a result of the Combination.
personnel and split shifts where feasible.
In addition, customer-facing field operations have moved to a remote engagement model and global restrictions have been placed on travel and in-person meetings.
are currently aligned with the Chinese government’s policies, but they may in the future diverge, requiring a change in such strategies.
In addition, in November 2018, the FDA issued a warning letter with respect to our manufacturing plant in Morgantown, West Virginia.
We implemented comprehensive restructuring and remediation activities at our Morgantown plant and on May 11, 2020, we received a closeout letter from the FDA.
- pricing a branded product at a discount equivalent to generic pricing, as was the case for Copaxone after the launch of Mylan’s generic glatiramer acetate products;
offset the amount invested to obtain such approvals.
restrictions, or other events could impair our ability to produce and ship products to the market on a timely basis and could, among other consequences, subject us to exposure to claims from customers.
Current or
marketing substantially equivalent products.
The patent litigation remains ongoing and we are taking legal steps to preserve the ability to exclusively provide to patients and physicians through patent expiry in July 2022.
take a position contrary to a position we have taken, and may impose or pursue civil and/or criminal sanctions.
The CIA has a five-year term and requires, among other things, enhancements to our
The size and complexity of our IT systems, and those of our third-party vendors with whom we contract, make such systems potentially vulnerable to service interruptions.
In addition, we and our vendors have experienced and expect to continue to experience phishing attempts, firewall and business email compromises and other third-party attacks on our or our vendors’ IT systems, networks and infrastructures.
For example, the state of California adopted the CCPA, which took effect on January 1, 2020, and California voters approved the California Privacy Rights Act in November 2020, which will be effective on January 1, 2023.
These laws provide California consumers with increased privacy rights and protections with respect to their personal information, including, among others, the right to know what personal information is collected, used, shared, or sold
and a right to deletion of personal information held by businesses and businesses’ service providers.
Recently, Brazil enacted significant data privacy legislation, the Lei Geral de Protecaode Dados, which became effective in August 2020.
Other countries, including India, Russia and Korea, are considering legislation implementing data protection requirements or requiring local storage and processing of data or similar requirements.
Viatris’ future dividend payments cannot be guaranteed.
In addition, we have invested in a number of clean energy operations capable of producing refined coal that we believe qualify for tax credits under Section 45 of the Code.
However, our clean energy investments may not yield the tax credits that we expect them to produce, whether as a result of a failure to satisfy the applicable conditions, changes in IRS rules or interpretation, or a decrease in demand for coal.
Congress could also modify or repeal Section 45 of the Code and remove the tax credits retroactively.
An excerpt. Shown here: 40 of 118 rewritten, 40 of 73 added and 40 of 49 removed. The counts are complete. For every sentence, read Item 1A. Risk Factors in the FY2021 filing and the FY2020 filing.
Item 7. Management’s Discussion and Analysis of Financial Condition And Results of Operations
231 rewritten, 89 added, 277 removed, 341 unchanged
Such forward-looking statements may include, without limitation, statements about the [added: Biocon Biologics Transaction; statements about the] Combination, the benefits and synergies of the Combination or our global restructuring program, future opportunities for the Company and its products and any other statements regarding the Company’s future operations, financial or operating results, capital allocation, dividend [removed: policy,] [added: policy and payments,] debt [removed: ratio,] [added: ratio and covenants,] anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competitions, [added: commitments, confidence in future results, efforts to create, enhance or otherwise unlock the value of our unique global platform,] and other expectations and targets for future periods.
- changes in relevant laws and regulations, including but not limited to changes in tax, healthcare and pharmaceutical laws and regulations [removed: globally;][added: globally (including the impact of potential tax reform in the U.S.);]
- uncertainties and matters beyond the control of management, including but not limited to general political and economic [removed: conditions] [added: conditions, inflation rates] and global exchange rates; and
Viatris is a global healthcare company formed in November 2020 [removed: through the combination of Mylan and Upjohn,] whose mission is to empower people worldwide to live healthier at every stage of [removed: life.][added: life, regardless of geography or circumstance.]
[removed: Viatris brings together] [added: With a global workforce of approximately 37,000, the Company has] industry leading commercial, R&D, regulatory, manufacturing, legal and medical expertise complemented by a strong commitment to quality and unparalleled geographic footprint to deliver high-quality medicines to patients in more than 165 countries and territories.
Viatris’ portfolio comprises more than 1,400 approved molecules across a wide range of key therapeutic areas, including globally recognized iconic and key [removed: brand, generic,] [added: brands, generics,] complex [removed: generic,] [added: generics,] and [removed: biosimilar products.][added: biosimilars.]
[removed: Viatris] [added: The Company] operates approximately [removed: 50] [added: 40] manufacturing sites worldwide that produce oral solid doses, injectables, complex dosage forms and APIs.
[removed: In conjunction with the formation of Viatris, the Company] [added: Viatris] has [removed: changed its] [added: four] reportable [removed: segments, from North America, Europe, and Rest of World, to] [added: segments:] Developed Markets, Greater China, JANZ, and Emerging Markets.
[removed: This approach reflects] [added: The Company reports segment information on] the [removed: Company’s] [added: basis of markets and geography, which reflects its] focus on bringing its broad and diversified portfolio of branded, complex generics and biosimilars, and generic products to people in markets everywhere.
Our Emerging Markets segment encompasses our [removed: operations] [added: presence] in [added: more than 125] countries with developing markets and emerging economies including [removed: countries] in Asia, [removed: the Middle East, South and Central America, Africa and] [added: Africa,] Eastern Europe, [added: Latin America] and [removed: also includes] the [added: Middle East as well as the] Company’s [removed: anti-retroviral] [added: ARV] franchise.
[removed: Additionally, pricing is often affected by factors outside of the Company’s control.Conversely,] [added: Conversely,] generic products generally experience less volatility over a longer period of time in Europe as compared to the U.S., primarily due to the role of government oversight of healthcare systems in the region.
During the fourth quarter of 2020, Viatris announced a significant global restructuring program in order to achieve synergies [removed: of $1 billion] and ensure that the organization is optimally structured and efficiently resourced to deliver sustainable value to patients, shareholders, customers, and other stakeholders.
[removed: The company expects to optimize] [added: As part of the restructuring, the Company is optimizing] its commercial capabilities and enabling functions, and [removed: close, downsize] [added: closing, downsizing] or [removed: divest up to 15] [added: divesting certain] manufacturing facilities globally that are deemed to be no longer viable either due to surplus capacity, challenging market dynamics or a shift in its product portfolio toward more complex products.
For the committed restructuring actions, the Company expects to incur total pre-tax charges [removed: ranging between $1.1 billion and] [added: of up to approximately] $1.4 billion.
Such charges are expected to include [removed: between $350 million and] [added: up to approximately] $450 million of non-cash charges mainly related to accelerated depreciation and asset impairment charges, including inventory write-offs.
The remaining estimated cash costs of [removed: between $750 million and] [added: up to approximately] $950 million are expected to be primarily related to severance and employee benefits expense, as well as other costs, including those related to contract terminations and [removed: decommissioning] [added: other plant disposal] costs.
In addition, management believes the potential annual savings related to these committed restructuring activities to be [removed: between $700 million and] [added: up to approximately] $900 million once fully implemented, with most of these savings expected to improve operating cash flow.
[removed: - Many] [added: As a result, many Viatris administrative offices continue operating under work from home protocols and some of our] customer facing field personnel [removed: have moved to] [added: continue on] a remote engagement model to ensure continued support for healthcare professionals, patient care and access to needed products.
[removed: - All] [added: Additionally, all] of our manufacturing facilities, and those of our key global partners, are currently operational and, at this time, we are not experiencing any significant [removed: disruptions to our supply chain, including the availability of APIs.][added: disruptions.]
[removed: - Inventory] [added: Current inventory] levels, both ours and those in our distribution channel, remain in-line with normal [removed: levels and are currently assessed to be sufficient for anticipated demand.][added: levels.]
Due to the Company’s ability to generate significant cash flows from operations, [removed: as well as its revolving credit agreement, other short-term] [added: combined with our access to] borrowing facilities and [removed: access to] capital markets, we believe that we currently have, and will maintain, the ability to meet foreseeable liquidity needs.
The global spread of COVID-19 has created [added: and continues to create] significant volatility, uncertainty and economic disruption affecting the markets we serve, [removed: and has had a negative impact] [added: including impacts] on [removed: our current year results of operations.][added: supply chain partners, third-party manufacturers, logistics providers and other vendors.]
The extent to which the COVID-19 pandemic will impact our business, operations and financial results in future periods will depend on numerous evolving factors that are beyond our control and that we may not be able to accurately [removed: predict.][added: predict, and could adversely impact our results of operations in future periods.]
The table below is a summary of the Company’s financial results for the year ended December 31, [removed: 2020] [added: 2021] compared to the prior year period:
| (In millions, except per share [removed: amounts)] [added: amounts and %s)] | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | Change | | | | | | % Change | | |
| Total revenues | | | $ | [removed: 11,946.0] [added: 17,886.3] | | | | | $ | [removed: 11,500.5] [added: 11,946.0] | | | | | $ | [removed: 445.5] [added: 5,940.3] | | | | | [removed: 4] [added: 50] | | % |
| Gross profit | | | [removed: 3,796.7] [added: 5,575.5] | | | | | | [removed: 3,897.6] [added: 3,796.7] | | | | | | [removed: (100.9)] [added: 1,778.8] | | | | | | [removed: (3)] [added: 47] | | % |
| [removed: (Loss) earnings] [added: Loss] from operations | | | [removed: (210.8)] [added: (34.0)] | | | | | | [removed: 715.5] [added: (210.8)] | | | | | | [removed: (926.3)] [added: 176.8] | | | | | | [removed: (129)] [added: nm] | | [removed: %] |
| [removed: Net] [added: U.S. GAAP net] (loss) earnings | | | [removed: (669.9)] [added: $] | [added: (1,269.1)] | | | | | [removed: 16.8] | | | | | | [removed: (686.7)] [added: $] | [added: (669.9)] | | | | | [removed: nm] | | | [added: | | | $ | 16.8 | | | | | | | |]
| Diluted [removed: (loss) earnings] [added: loss] per share | | | $ | [removed: (1.11)] [added: (1.05)] | | | | | $ | [removed: 0.03] [added: (1.11)] | | | | | $ | [removed: (1.14)] [added: 0.06] | | | | | [removed: nm] [added: 5] | | [added: %] |
| [added: (In millions)] | | | Year Ended December [removed: 31, | | | | | | | | | | | | | | | | | | | | | | | |] [added: 31, 2021] | | | | | | [added: Year Ended December 31, 2020] | | |
| (In [removed: millions)] [added: millions, except %s)] | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | % Change | | | | | | [removed: 2020] [added: 2021] Currency Impact (1) | | | | | | [removed: 2020] [added: 2021] Constant Currency Revenues | | | | | | Constant Currency % Change (2) | | |
| Total net sales | | | [removed: 11,819.9] [added: 17,813.6] | | | | | | [removed: 11,370.3] [added: 11,819.9] | | | | | | [removed: 4] [added: 51] | | % | | | | [removed: 28.0] [added: (206.4)] | | | | | | [removed: 11,847.9] [added: 17,607.2] | | | | | | [removed: 4] [added: 49] | | % |
| Other revenues (3) | | | [removed: 126.1] [added: 72.7] | | | | | | [removed: 130.2] [added: 126.1] | | | | | | [removed: (3)] [added: (42)] | | % | | | | (1.0) | | | | | | [removed: 125.1] [added: 71.7] | | | | | | [removed: (4)] [added: (43)] | | % |
| Consolidated total revenues (4) | | | $ | [removed: 11,946.0] [added: 17,886.3] | | | | | $ | [removed: 11,500.5] [added: 11,946.0] | | | | | [removed: 4] [added: 50] | | % | | | | $ | [removed: 27.0] [added: (207.4)] | | | | | $ | [removed: 11,973.0] [added: 17,678.9] | | | | | [removed: 4] [added: 48] | | % |
(2)The constant currency percentage change is derived by translating net sales or revenues for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from [removed: 2020] [added: 2021] constant currency net sales or revenues to the corresponding amount in the prior year.
(3)For the year ended December 31, [removed: 2020,] [added: 2021,] other revenues in Developed Markets, [removed: Greater China,] JANZ, and Emerging Markets were approximately [removed: $94.0 million, $0.3] [added: $51.0] million, [removed: $10.5] [added: $1.5] million, and [removed: $21.3] [added: $20.2] million, respectively.
For the year ended December 31, [removed: 2020,] [added: 2021,] the Company reported total revenues of [removed: $11.95] [added: $17.89] billion, compared to [removed: $11.50] [added: $11.95] billion for the comparable prior year period, representing an increase of [removed: $445.5 million,] [added: $5.94 billion,] or [removed: 4%.][added: 50%.]
Net sales for the year ended December 31, [removed: 2020] [added: 2021] were [removed: $11.82] [added: $17.81] billion, compared to [removed: $11.37] [added: $11.82] billion for the comparable prior year period, representing an increase of [removed: $449.6 million,] [added: $5.99 billion,] or [removed: 4%.][added: 51%.]
Other revenues for the year ended December 31, [removed: 2020] [added: 2021] were [removed: $126.1] [added: $72.7] million, compared to [removed: $130.2] [added: $126.1] million for the comparable prior year period, a decrease of [removed: $4.1] [added: $53.4] million.
- the pending Biocon Biologics Transaction may not achieve its intended benefits;
Improving the ability of patients to gain access to sustainable and high-quality healthcare is our relentless pursuit.
One that rests on visionary thinking, determination and best-in-class capabilities that were strategically built to remove barriers across the health spectrum and advance access globally.
Viatris’ seasoned management team is focused on ensuring that the Company is optimally structured and efficiently resourced to deliver sustainable value to patients, shareholders, customers and other stakeholders.
Additionally, pricing is often affected by factors outside of the Company’s control.
*Biocon Biologics Agreement*
On February 28, 2022, the Company entered into an agreement to contribute its biosimilars business to Biocon Biologics.
Under the terms of the Biocon Agreement, at closing Viatris will receive an up-front cash payment of $2.0 billion, $1.0 billion of convertible preferred equity and up to $335 million as additional cash payments that are expected to be paid in 2024.
Viatris will own a stake of at least 12.9% of Biocon Biologics, on a fully-diluted basis, and will have certain priority rights with respect to certain liquidity events.
The companies will also enter into a two-year transition services agreement, subject to extension in certain circumstances, during which time Viatris will provide certain commercial and administrative services for an applicable service fee.
The transaction is expected to close in the second half of 2022 and is subject to customary closing conditions (including regulatory approvals).
*Share Repurchase Program*
On February 28, 2022, the Company announced that its Board of Directors had authorized a share repurchase program for the repurchase of up to $1.0 billion of the Company’s shares of common stock.
The Company has not yet repurchased any shares of common stock under the share repurchase program and the share repurchase program does not obligate the Company to acquire any particular amount of common stock.
*Cyclosporine Ophthalmic Emulsion*
On February 3, 2022, the Company announced that it had received approval from the FDA for its ANDA for Cyclosporine Ophthalmic Emulsion 0.05%, the first generic version of Allergan's Restasis®.
Cyclosporine Ophthalmic Emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, also known as dry eye.
The commercial launch of the product occurred in February 2022.
*SEMGLEE®*
On June 11, 2020, the FDA approved the SEMGLEE® vial and pen products, which the Company began selling on August 31, 2020.
On July 28, 2021, Viatris and Biocon announced that the FDA had approved SEMGLEE® (insulin glargine-yfgn) injection as the first interchangeable biosimilar product under the 351(k) regulatory pathway.
The interchangeable SEMGLEE® product, which allows substitution of SEMGLEE® for the reference product, Lantus®, at the pharmacy counter, was launched in the fourth quarter of 2021.
The Company has exclusivity for 12 months from launch before the FDA can approve another biosimilar interchangeable to Lantus®.
| Net loss | | | (1,269.1) | | | | | | (669.9) | | | | | | (599.2) | | | | | | (89) | | % |
2021 Compared to 2020
| Developed Markets | | | $ | 10,428.7 | | | | | $ | 8,510.9 | | | | | 23 | | % | | | | $ | (185.1) | | | | | $ | 10,243.6 | | | | | 20 | | % |
| Greater China | | | 2,212.8 | | | | | | 259.9 | | | | | | nm | | | | | | (9.3) | | | | | | 2,203.5 | | | | | | nm | | |
| JANZ | | | 2,027.4 | | | | | | 1,195.3 | | | | | | 70 | | % | | | | (2.7) | | | | | | 2,024.7 | | | | | | 69 | | % |
| Emerging Markets | | | 3,144.7 | | | | | | 1,853.8 | | | | | | 70 | | % | | | | (9.3) | | | | | | 3,135.4 | | | | | | 69 | | % |
New product sales include new products launched in 2021 and the carryover impact of new products, including business development, launched within the last twelve months.
We estimate that the COVID-19 pandemic positively impacted our 2021 net sales compared to the prior year by approximately 2%, primarily driven by a partial recovery of customer buying patterns in the current year.
This increase was partially offset by lower pricing and volumes on net sales of existing products, including Wixela® Inhub®, Perforomist®, Xulane®, and Miacalcin® within the U.S., due to additional competition.
Lower volumes were also due to the impact of product divestitures, including certain North American OTC products during the second quarter of 2021 and other products during 2020 as a result of the Combination.
This increase was primarily the result of the incremental net sales from the Upjohn Business of $666.6 million, and higher net sales of existing products driven by higher volumes primarily related to Amitiza® and Creon®, as well as the impact of the termination of the collaboration arrangement with Pfizer in the prior year in Japan.
These increases were partially offset by lower volumes and, to a lesser extent, pricing as a result of customer purchasing patterns and competitive market conditions, including for ARV products.
Additional incremental cost of sales from the Upjohn Business, including the impact of amortization expense, was $3.57 billion for the year ended December 31, 2021.
This includes incremental amortization expense of $2.01 billion primarily for purchase accounting related amortization of intangible assets and the fair value step-up of acquired inventory.
| (In millions, except %s) | | | 2021 | | | | | | 2020 | | |
This increase was primarily due to additional incremental costs associated with the Upjohn Business of $81.7 million, higher expenses related to licensing arrangements for products in development, and increased costs for inventory validation batches for certain products under development.
Litigation settlements in 2021 include a $264.0 million charge for the EpiPen® related settlement.
By integrating the strengths of these two businesses, including our global workforce of approximately 45,000 employees and contractors, Viatris aims to deliver increased access to affordable, quality medicines for patients worldwide regardless of geography or circumstance.
Viatris reports segment information on the basis of markets and geography.
For example, several companies launched a generic to Lyrica® in Japan in December 2020 despite pending patent infringement litigation.
While the litigation remains ongoing, the rate of generic conversion is significant and, combined with market dynamics relating to the COVID-19 pandemic, the Company expects a significant reduction in the annual revenues of Lyrica®.
As a result, Viatris expects that up to 20% of its global workforce of approximately 45,000 may be impacted upon completion of the restructuring initiative.
*2016 Restructuring Program*
Mylan previously announced a restructuring program representing a series of actions in certain locations that are anticipated to further streamline its operations globally.
We have incurred total restructuring related costs of approximately $733.0 million through December 31, 2020.
The 2016 Restructuring Program is substantially complete at December 31, 2020.
In April 2018, the FDA completed an inspection at Mylan’s plant in Morgantown, West Virginia and made observations through a Form 483.
In the fourth quarter of 2018, Mylan received a warning letter related to the previously disclosed observations at the plant.
The issues raised in the warning letter were addressed within the context of the Mylan’s comprehensive restructuring and remediation activities.
On May 11, 2020 Mylan received the close-out of the warning letter.
On December 11, 2020, the Company announced that it expects the Morgantown plant to be closed or divested as part of the 2020 Restructuring Program.
The following section discusses the important measures the Company is taking in light of the COVID-19 pandemic.
Employee Health and Safety
- Viatris continues to align with government and health authority guidelines in an effort to safeguard our workforce and continues to make assessments on an ongoing basis.
- While Viatris’ business operations are currently considered essential based on government guidelines throughout the world due to the important role pharmaceutical manufacturers play within the global healthcare system, many Viatris administrative offices continue operating under work from home protocols.
- Because protecting the health and safety of our workforce remains paramount, Viatris has taken extra precautions at manufacturing facilities to aid in the protection of site personnel and operations, including the implementation of social distancing guidelines, daily health assessments and split shifts where feasible.
- Global restrictions have been placed on travel and in-person meetings.
- Viatris has taken steps to protect the safety of study participants, our employees and staff at clinical trial sites and ensure regulatory compliance and scientific integrity of trial data.
Continuing to Produce Critically Needed Medicines
*Manufacturing and Supply*
- Viatris has activated worldwide business continuity plans to seek to ensure that our global supply chain platform continues to operate without significant disruption.
Also, we are currently not experiencing any negative impact on our customer service levels.
- Viatris continues to engage with regulatory authorities around the world who are committed to maintaining ongoing regulatory processes while also continuing to make available our global R&D, regulatory and manufacturing expertise and capacity to partners who may be in need of additional resources.
*Commercial Operations*
- We have and continue to experience certain negative fluctuations in demand trends due to COVID-19.
We will continue to monitor trends closely as we work to ensure patients have access to needed medicine.
Deploying Resources and Expertise in the Fight Against COVID-19
*Product Development*
- On May 12, 2020, Mylan announced a global collaboration with Gilead Sciences, Inc. to expand access to the investigational antiviral remdesivir for the potential treatment of COVID-19.
Under the terms of the license agreement the Company has rights to manufacture and distribute remdesivir in 127 low-and middle-income countries, including India.
- On July 6, 2020, Mylan announced that the DCGI approved its remdesivir 100 mg/vial for restricted emergency use in India as part of the DCGI’s accelerated approval process to address urgent, unmet needs amid the evolving COVID-19 pandemic.
- On November 20, 2020, the WHO issued a conditional recommendation against the use of remdesivir in hospitalized patients, regardless of disease severity, as there was no evidence that remdesivir improved survival and other outcomes in these patients.
Maintaining the Health of Our Overall Business
*Access to Capital Markets and Liquidity*
While currently we are not experiencing any negative liquidity trends related to the COVID-19 pandemic, we continue to closely monitor developments and the potential negative impact on our operating performance and our ability to access the capital markets.
*Impact on Results of Operations*
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
An excerpt. Shown here: 40 of 231 rewritten, 40 of 89 added and 40 of 277 removed. The counts are complete. For every sentence, read Item 7. Management’s Discussion and Analysis of Financial Condition And Results of Operations in the FY2021 filing and the FY2020 filing.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
5 rewritten, 0 added, 1 removed, 20 unchanged
If there were an adverse change in foreign currency exchange rates of 10%, the expected net effect on net income related to [removed: Viatris’s] [added: Viatris’] foreign currency denominated financial instruments would not be material.
Non-U.S. dollar borrowings, principally our Euro [added: and Yen] denominated long-term debt, are used to hedge the foreign currency exposures of our net investment in certain foreign affiliates and are designated as hedges of net investments.
As of December 31, [removed: 2020,] [added: 2021,] Viatris’ outstanding fixed rate borrowings consist principally of [removed: $23.30] [added: $20.60] billion notional amount of senior [removed: notes] [added: U.S. dollar] and Euro notes.
As of December 31, [removed: 2020,] [added: 2021,] the fair value of our outstanding fixed rate senior [removed: notes] [added: U.S. dollar] and Euro notes was approximately [removed: $25.90] [added: $22.01] billion.
A 100 basis point change in interest rates on Viatris’ variable rate debt, net of interest rate swaps, would result in a change in interest expense of approximately [removed: $17.0] [added: $18.4] million per year.
Viatris’ primary areas of foreign exchange risk relative to the U.S. Dollar are the Euro, Indian Rupee, Chinese Renminbi, Japanese Yen, Australian Dollar, Canadian Dollar, Pound Sterling and South Korean Won.
Item 1. Business
84 rewritten, 62 added, 22 removed, 204 unchanged
Viatris is a global healthcare company formed in November 2020 [removed: through the combination of Mylan and the Upjohn Business] whose mission is to empower people worldwide to live healthier at every stage of [removed: life.][added: life, regardless of geography or circumstance.]
[removed: Viatris brings together] [added: With a global workforce of approximately 37,000, the Company has] industry leading commercial, R&D, regulatory, manufacturing, legal and medical expertise complemented by a strong commitment to quality and unparalleled geographic footprint to deliver high-quality medicines to patients in more than 165 countries and territories.
Viatris’ portfolio comprises more than 1,400 approved molecules across a wide range of key therapeutic areas, including globally recognized iconic and key brands, [removed: generic,] [added: generics,] complex [removed: generic] [added: generics,] and biosimilars.
[removed: Viatris] [added: The Company] operates approximately [removed: 50] [added: 40] manufacturing sites worldwide that produce oral solid doses, injectables, complex dosage forms and APIs.
In accordance with the terms and conditions of the BCA and SDA, (1) Pfizer contributed the Upjohn Business to Viatris (the “Contribution”), so that the Upjohn Business was separated from the remainder of Pfizer’s businesses (the “Separation”), (2) following the Separation, Pfizer distributed, on a pro rata basis (based on the number of shares of Pfizer common stock held by holders of Pfizer common stock as of the record date of November 13, 2020 (the “Record Date”)), all of the shares of Viatris common stock held by Pfizer to Pfizer stockholders as of the Record Date (the “Distribution”), and (3) immediately following the Distribution, Viatris and Mylan engaged in a strategic business combination transaction (the [removed: “Combination” or the “Upjohn Combination”).][added: “Combination”).]
For additional information, see “Risk Factors – *Viatris could incur operational difficulties or losses if [added: Pfizer is unable to perform under the agreements entered into as part of the Combination, if] we are unable to obtain the same types and level of services and resources that historically have been provided to the legacy Upjohn Business by Pfizer, [removed: if Pfizer is unable to perform under the agreements entered into as part of the Combination] or if we are required to make payments to Pfizer pursuant to indemnities agreed to as part of the Combination.*”
Unless otherwise indicated, industry data included in this Item 1 are sourced from IQVIA Holdings Inc. and are for the twelve months ended November [removed: 2020.][added: 2021.]
Viatris product and other company data included in this Item 1 are from internal sources and are as of November 30, [removed: 2020 and do not reflect the impact of the global restructuring program.][added: 2021.]
[removed: ][added: ]
[removed: Providing] [added: Viatris provides] high-quality, trusted medicines, regardless of geography or circumstance. We are committed to improving access to high-quality medicines while working to ensure a reliable supply so patients can get the treatments they need, when and where they need them.
Our global portfolio, supported by our science, medical and manufacturing expertise, delivers global iconic and key brands, complex generics, biosimilars, [added: generics - including complex] and [removed: generics.][added: branded generics - and over-the-counter products.]
[removed: ][added: ]
[removed: Advancing] [added: Viatris is advancing] sustainable operations and innovative solutions to improve patient health. Viatris is committed to providing steady leadership in a world that is constantly evolving.
[removed: Through our commitment] [added: We are committed] to advancing [added: responsible and] sustainable [removed: operations, we work to systematically] [added: operations] and [added: work] diligently [added: to] minimize our environmental footprint across the Viatris [removed: network.][added: network while safeguarding access to medicine.]
Our integrated, comprehensive approach focuses on [removed: managing our] water, air emissions, waste, climate change and [removed: energy impact.][added: energy.]
- Robust global technical resources, including [removed: more than 2,500] [added: thousands of] scientists, [removed: more than 1,000] regulatory experts and [removed: more than 600] medical and product safety professionals working around the world on innovative therapies and solutions for patients everywhere.
- Strong global commercial team, including [removed: more than 13,000] sales team members and [removed: more than 1,100] marketing professionals whose goal is to ensure that products are shipped [removed: globally] to [removed: more than 60,000 customers.][added: customers around the globe.]
- Diverse and differentiated global portfolio includes products in more than 10 major therapeutic areas, including both infectious diseases and [removed: non-communicable diseases] [added: NCDs] and medicines that treat 9 out of 10 of the [removed: World Health Organization’s] [added: WHO’s] leading causes of death.
We are a leading supplier of medicines to the HIV/AIDS community around the world, with a legacy of providing access to [removed: high quality] [added: high-quality] and affordable ARVs in more than 100 countries.
Together, with our commitment to provide access to a sustainable, affordable, and diverse portfolio of high-quality medicines and our goal to be a Partner of [removed: Choice™] [added: Choice®] for companies big and small, Viatris works to improve access and meet evolving healthcare needs around the world.
[removed: ][added: ]
[added: Leveraging our collective expertise to connect people to products and services.] We have a strong history of partnering with other pharmaceutical companies, nonprofit organizations, government agencies, policymakers, trade associations and alliances, industry researchers and patient advocacy groups.
[removed: *Collaboration] [added: Licensing] and [removed: Licensing Agreements*][added: Other Partner Agreements]
We periodically enter into commercial [removed: collaboration and] licensing [added: and other partner] agreements with other pharmaceutical companies for the development, manufacture, marketing and/or sale of pharmaceutical products.
Doing so helps us share risks and costs, leverage strengths and scale up [removed: commercialization.][added: commercialization, but usually requires us to also share future profits.]
Our significant [removed: collaboration] [added: licensing and other partner] agreements are primarily focused on the development, manufacturing, supply and commercialization of multiple, high-value generic biosimilar compounds, insulin analog products and respiratory products, among other complex products.
Refer to Note 18 [removed: Collaboration] [added: *Licensing] and [removed: Licensing Agreements] [added: Other Partner Agreements*] included in Part II.
[removed: *Global] [added: Our Global] Healthcare [removed: Gateway*™][added: Gateway® is open for business.]
[removed: We have] [added: Viatris has] developed [added: an] end-to-end experience across the total product life cycle, which includes global regulatory licensing, launch, growth and post-approval lifecycle management.
Our research, development and medical platform seeks to maximize the impact of our existing [removed: product] portfolio by examining whether there is an opportunity for new indications, label extensions, [removed: product] formulations, and market registrations for our products.
The manufacturing of APIs and finished dosage forms is performed by a combination of internal and external manufacturing [removed: operations, with much of our manufacturing being vertically integrated; this means we produce many of our own APIs and finished dosage forms.][added: operations.]
[removed: Like many pharmaceutical companies,] [added: As a result,] we supplement our production footprint through arrangements with other manufacturers.
The Company’s significant manufacturing, warehousing and distribution activities are located primarily in the U.S., Puerto Rico, Singapore, [added: India, Japan, China, and] certain E.U. countries, including [removed: Ireland, India, Japan and China.][added: Ireland.]
We [removed: are committed to environmentally responsible conduct and have policies and procedures to support our] work [removed: to] systematically and diligently [added: to] minimize our environmental footprint.
[removed: Numbering more than 60,000, our] [added: Our] customers include retail and pharmacy establishments, wholesalers and distributors, payers, insurers and governments, and institutions such as hospitals; among others.
The table below displays the percentage of consolidated net sales to our largest customers during the years ended December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018.][added: 2019.]
| | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2018] [added: 2019] | | |
| McKesson Corporation | | | [removed: 13] [added: 9] | | % | | | | [removed: 15] [added: 13] | | % | | | | [removed: 12] [added: 15] | | % |
| AmerisourceBergen Corporation | | | [removed: 10] [added: 9] | | % | | | | [removed: 9] [added: 10] | | % | | | | [removed: 8] [added: 9] | | % |
| Cardinal Health, Inc. | | | [removed: 8] [added: 5] | | % | | | | 8 | | % | | | | 8 | | % |
Improving the ability of patients to gain access to sustainable and high-quality healthcare is our relentless pursuit.
One that rests on visionary thinking, determination and best-in-class capabilities that were strategically built to remove barriers across the health spectrum and advance access globally.
Viatris’ seasoned management team is focused on ensuring that the Company is optimally structured and efficiently resourced to deliver sustainable value to patients, shareholders, customers and other stakeholders.
The Company began the process of transitioning certain capabilities in 2021, but expects significant changes to occur in 2022 as a result of further transitioning of services and information and other systems.
This includes our previously disclosed significant global restructuring program, which is described further in Note 17 included in Part II.
Item 8 of this Form 10-K.
We do so via Access, Leadership and Partnership.
As a company, Viatris:
- Covers a broad range of therapeutic areas.
We produce medicines for patients across a broad range of major therapeutic areas.
- Helps ease the burden of noncommunicable diseases. According to the WHO, NCDs, such as ischemic heart disease, stroke, diabetes, certain cancers and chronic obstructive pulmonary disease, were among the leading causes of death globally as of 2016.
NCDs affect people of every age, gender and socioeconomic status in every corner of the world, and pose a heavy burden on individuals, families and communities.
To overcome this global public health threat, patients worldwide need a partner they can trust – one that not only believes everyone deserves good health, but also has the portfolio, experience and expertise to make this belief a reality.
- Helps hearts stay healthier. According to the WHO, coronary heart disease is the number one cause of death globally.
Viatris collaborates with many organizations to help prevent, diagnose, and treat many cardiovascular illnesses.
Our deep experience in emerging and developed markets affords a tried-and-true method of achieving high impact across the patient experience, from awareness to adherence.
In close collaboration with governments, healthcare providers, technology partners and patients, we at Viatris work to nurture healthcare systems that can adapt and respond to patients’ ever-changing needs.
We continue to collaborate with medical associations, patient advocacy groups and academia to develop innovative, integrated solutions and programs to help strengthen both the delivery and quality of healthcare.
- Fights infectious disease.
We are also a global leader in treating infectious diseases such as HIV/AIDS, hepatitis, and tuberculosis, and offer an extensive portfolio across these disease states.
While many important strides have been made to treat these illnesses, there is still more to be done in countries where lack of access to therapeutics, preventative treatment and diagnostics often result in patients not receiving proper care, and those where HIV transmission continues thirty years into the epidemic.
From manufacturing a pediatric-friendly antiretroviral used to treat HIV-positive infants to providing HIV self-tests in some low- and middle-income countries, we are innovating to help patients.
An Increasingly Innovative and Differentiated Pipeline
Our confidence in the future delivery of our pipeline is rooted in our strong historic development programs and list of firsts, including the recent approval of the generic version of Allergan's Restasis® and Semglee® (insulin glargine-yfgn), the first interchangeable biosimilar ever approved in the U.S., and the launch of the first biosimilar to Humira® (adalimumab) in Japan.
In addition, we are working on many other programs, including the potential to be first to market for our BOTOX® (onabotulinumtoxinA) and Eylea® (aflibercept) biosimilars.
While we will continue to diligently pursue important generics opportunities, we will increasingly focus on limited-competition complex and novel products targeting gaps in care, all with a first-to-market emphasis and serving our mission of patient access.
Complex products categories are critical to patient health and are growing at a rapid pace.
We believe that Viatris’ early vision and continued commitment has given us one of the deepest complex product pipelines in the industry, and that we are well positioned to capitalize on these growth opportunities in the future.
Viatris operates approximately 40 manufacturing sites worldwide that produce oral solid doses, injectables, complex dosage forms and APIs on five different continents.
Together with a global, flexible and diverse supply chain, our platform strives to mitigate risks of disruption and ensure supply reliability.
Our efforts to build a responsive global network have helped us maintain a reliable supply of much needed medicines as the fight against the COVID-19 pandemic continues.
We engage with around 100 trade associations and not-for-profit organizations across more than 40 countries, as well as patient and industry groups and other partners.
Our Global Healthcare Gateway® Built to Fuel Growth and Partnerships
We are actively engaging with potential partners to help them accelerate possibilities of using their own healthcare assets to reach more patients by leveraging our unique global platform – our R&D, supply chain, manufacturing, regulatory, commercial and legal expertise.
Although the global platforms and infrastructure supporting our innovative Global Healthcare Gateway are not entirely new, what is new is how we are enhancing our capital allocation approach to business development, and our organic and inorganic R&D investments through a focused governance structure to ensure the highest level of strategic decision-making.
Internally, many of the products we produce are vertically integrated; meaning we manufacture both the APIs and finished dosage forms related to those products.
We are committed to advancing sustainable operations and innovative solutions to improve patient health.
This means we focus on responsible conduct and have global policies and procedures to support our work.
Environmental and human health are interconnected, a relationship underscored by climate change and water stress.
Our integrated, comprehensive approach focuses on water, air emissions, waste, climate change and energy.
By integrating the strengths of these two businesses, including our global workforce of approximately 45,000 employees and contractors, Viatris aims to deliver increased access to affordable, quality medicines for patients worldwide regardless of geography or circumstance.
Following the transitional periods or upon Viatris’ exit of the services prior to expiry of such periods, Viatris will need to absorb, replicate or outsource from other providers certain facilities, systems, infrastructure, and personnel to which it no longer has access under the transitional agreements.
This includes embarking on our previously disclosed significant global restructuring program, additional details were announced on December 11, 2020 and February 25, 2020.
We do so via:
We have more than 50 manufacturing facilities producing oral solid doses, injectables, complex dosage forms and APIs in 15 countries on five different continents, which mitigates risk of disruption in any given part of the world.
In fact, in 2019, we collaborated with more than 60 associations worldwide on global public health issues.
As the world’s healthcare needs evolve, our Global Healthcare Gateway™ offers partners ready access to expanded markets through an innovative global infrastructure that connects people around the world to the high quality medicines and services they need.
Powered by our best-in-class manufacturing, scientific and legal expertise and proven commercial capabilities with unparalleled reach, the Global Healthcare Gateway™ paves the way for Viatris to be the Partner of Choice™ for those looking to expand access to their assets, empowering more people worldwide to live healthier at every stage of life.
As a result of the Combination, we estimate that the percentages to our significant customers could change in future periods.
Viatris reports segment information on the basis of markets and geography.
Important recent launches include Dimethyl Fumarate, Mesalamine extended release capsule, Trastuzumab injection, and Fludrocortisone.
Our products compete in both the hospital segment, where reimbursement is primarily funded by the government, and the retail pharmacy channel, which is mainly self-pay.
The URP policy will cap reimbursement of molecules at their VBP tender winning price, is expected to start in during 2021.
The Emerging Markets segment also includes the Company’s anti-retroviral franchise.
Human therapeutic products are subject to rigorous preclinical and clinical testing to gather data to support approval, which requires extensive data and information; manufacturing is conducted under exacting conditions governed by extensive regulation; and post-approval activities, such as advertising and promotion and pharmacovigilance, are subject to extensive regulation.
Our product pipeline includes a variety of dosage forms.
Collectively, the investments in all our research efforts represent more than 2,000 products under development or pending approval around the world.
We work to advance responsible and sustainable operations and leverage our collective expertise and perspectives to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve.
Our passionate and talented workforce is fundamental in bringing Viatris’ mission to life.
Together, we are creating a performance-driven, highly engaging and inclusive culture with colleagues united by a shared purpose, a dedication to excellence and a mutual respect for one another that enables us to fully realize the potential of this new enterprise.
As a new company spanning nearly every corner of the world, we are energized by the diversity of our workforce.
We are bringing together colleagues and allies with common interests and diverse experiences in voluntary networks called employee resource groups.
An excerpt. Shown here: 40 of 84 rewritten, 40 of 62 added and all 22 removed. The counts are complete. For every sentence, read Item 1. Business in the FY2021 filing and the FY2020 filing.
Item 3. Legal Proceedings
0 rewritten, 0 added, 1 removed, 1 unchanged
PART II
Cover and table of contents
41 rewritten, 34 added, 28 removed, 188 unchanged
| | | | For the Fiscal Year Ended December 31, [removed: 2020] [added: 2021] | | |
| | | | For the transition period from [removed: to .] [added: to] | | |
Yes [removed: ☐ No] ☑ [added: No ☐]
| Large accelerated filer | | | [removed: ☐] [added: ☑] | | | | | | | | | Accelerated filer | | | | | | ☐ | | |
| Non-accelerated filer | | | [removed: ☑] [added: ☐] | | | | | | | | | Smaller reporting company | | | | | | ☐ | | |
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant as of June [removed: 26, 2020,] [added: 30, 2021,] the last business day of the registrant’s most recently completed second fiscal [removed: quarter: No established public trading market for the registrant’s common stock as of such date.][added: quarter, was approximately $17,237,737,213.]
The number of shares of common stock outstanding, par value $0.01 per share, of the registrant as of February 22, [removed: 2021] [added: 2022] was [removed: 1,207,082,624.][added: 1,209,576,280.]
For the Year Ended December 31, [removed: 2020][added: 2021]
| ITEM 1. | | | [removed: [Business](#i813891f659a548d0a222b7186f884e88_13)] [added: [Business](#ie2fdfbf3ed474f27b20ef16155bfdf72_13)] | | | [removed: [8](#i813891f659a548d0a222b7186f884e88_13)] [added: [9](#ie2fdfbf3ed474f27b20ef16155bfdf72_13)] | | |
| ITEM 1A. | | | [Risk [removed: Factors](#i813891f659a548d0a222b7186f884e88_82)] [added: Factors](#ie2fdfbf3ed474f27b20ef16155bfdf72_82)] | | | [removed: [17](#i813891f659a548d0a222b7186f884e88_82)] [added: [20](#ie2fdfbf3ed474f27b20ef16155bfdf72_82)] | | |
| ITEM 1B. | | | [Unresolved Staff [removed: Comments](#i813891f659a548d0a222b7186f884e88_85)] [added: Comments](#ie2fdfbf3ed474f27b20ef16155bfdf72_85)] | | | [removed: [46](#i813891f659a548d0a222b7186f884e88_85)] [added: [52](#ie2fdfbf3ed474f27b20ef16155bfdf72_85)] | | |
| ITEM 2. | | | [removed: [Properties](#i813891f659a548d0a222b7186f884e88_88)] [added: [Properties](#ie2fdfbf3ed474f27b20ef16155bfdf72_88)] | | | [removed: [46](#i813891f659a548d0a222b7186f884e88_88)] [added: [52](#ie2fdfbf3ed474f27b20ef16155bfdf72_88)] | | |
| ITEM 3. | | | [Legal [removed: Proceedings](#i813891f659a548d0a222b7186f884e88_91)] [added: Proceedings](#ie2fdfbf3ed474f27b20ef16155bfdf72_91)] | | | [removed: [46](#i813891f659a548d0a222b7186f884e88_91)] [added: [52](#ie2fdfbf3ed474f27b20ef16155bfdf72_91)] | | |
| ITEM 5. | | | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#i813891f659a548d0a222b7186f884e88_97)] [added: Securities](#ie2fdfbf3ed474f27b20ef16155bfdf72_97)] | | | [removed: [47](#i813891f659a548d0a222b7186f884e88_97)] [added: [53](#ie2fdfbf3ed474f27b20ef16155bfdf72_97)] | | |
| ITEM 7. | | | [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#i813891f659a548d0a222b7186f884e88_103)] [added: Operations](#ie2fdfbf3ed474f27b20ef16155bfdf72_103)] | | | [removed: [50](#i813891f659a548d0a222b7186f884e88_103)] [added: [55](#ie2fdfbf3ed474f27b20ef16155bfdf72_103)] | | |
| ITEM 7A. | | | [Quantitative and Qualitative Disclosures about Market [removed: Risk](#i813891f659a548d0a222b7186f884e88_139)] [added: Risk](#ie2fdfbf3ed474f27b20ef16155bfdf72_139)] | | | [removed: [78](#i813891f659a548d0a222b7186f884e88_139)] [added: [77](#ie2fdfbf3ed474f27b20ef16155bfdf72_139)] | | |
| ITEM 8. | | | [Financial Statements and Supplementary [removed: Data](#i813891f659a548d0a222b7186f884e88_142)] [added: Data](#ie2fdfbf3ed474f27b20ef16155bfdf72_142)] | | | [removed: [80](#i813891f659a548d0a222b7186f884e88_142)] [added: [78](#ie2fdfbf3ed474f27b20ef16155bfdf72_142)] | | |
| ITEM 9. | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#i813891f659a548d0a222b7186f884e88_259)] [added: Disclosure](#ie2fdfbf3ed474f27b20ef16155bfdf72_250)] | | | [removed: [158](#i813891f659a548d0a222b7186f884e88_259)] [added: [148](#ie2fdfbf3ed474f27b20ef16155bfdf72_250)] | | |
| ITEM 9A. | | | [Controls and [removed: Procedures](#i813891f659a548d0a222b7186f884e88_262)] [added: Procedures](#ie2fdfbf3ed474f27b20ef16155bfdf72_253)] | | | [removed: [158](#i813891f659a548d0a222b7186f884e88_262)] [added: [148](#ie2fdfbf3ed474f27b20ef16155bfdf72_253)] | | |
| ITEM 9B. | | | [Other [removed: Information](#i813891f659a548d0a222b7186f884e88_265)] [added: Information](#ie2fdfbf3ed474f27b20ef16155bfdf72_256)] | | | [removed: [158](#i813891f659a548d0a222b7186f884e88_265)] [added: [148](#ie2fdfbf3ed474f27b20ef16155bfdf72_256)] | | |
| ITEM 10. | | | [Directors, Executive Officers and Corporate [removed: Governance](#i813891f659a548d0a222b7186f884e88_271)] [added: Governance](#ie2fdfbf3ed474f27b20ef16155bfdf72_262)] | | | [removed: [159](#i813891f659a548d0a222b7186f884e88_271)] [added: [149](#ie2fdfbf3ed474f27b20ef16155bfdf72_262)] | | |
| ITEM 11. | | | [Executive [removed: Compensation](#i813891f659a548d0a222b7186f884e88_274)] [added: Compensation](#ie2fdfbf3ed474f27b20ef16155bfdf72_265)] | | | [removed: [159](#i813891f659a548d0a222b7186f884e88_274)] [added: [149](#ie2fdfbf3ed474f27b20ef16155bfdf72_265)] | | |
| ITEM 12. | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#i813891f659a548d0a222b7186f884e88_277)] [added: Matters](#ie2fdfbf3ed474f27b20ef16155bfdf72_268)] | | | [removed: [159](#i813891f659a548d0a222b7186f884e88_277)] [added: [149](#ie2fdfbf3ed474f27b20ef16155bfdf72_268)] | | |
| ITEM 13. | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#i813891f659a548d0a222b7186f884e88_280)] [added: Independence](#ie2fdfbf3ed474f27b20ef16155bfdf72_271)] | | | [removed: [159](#i813891f659a548d0a222b7186f884e88_280)] [added: [149](#ie2fdfbf3ed474f27b20ef16155bfdf72_271)] | | |
| ITEM 14. | | | [Principal Accounting Fees and [removed: Services](#i813891f659a548d0a222b7186f884e88_283)] [added: Services](#ie2fdfbf3ed474f27b20ef16155bfdf72_274)] | | | [removed: [159](#i813891f659a548d0a222b7186f884e88_283)] [added: [149](#ie2fdfbf3ed474f27b20ef16155bfdf72_274)] | | |
| ITEM 15. | | | [Exhibits and Consolidated Financial Statement [removed: Schedules](#i813891f659a548d0a222b7186f884e88_289)] [added: Schedules](#ie2fdfbf3ed474f27b20ef16155bfdf72_280)] | | | [removed: [160](#i813891f659a548d0a222b7186f884e88_289)] [added: [150](#ie2fdfbf3ed474f27b20ef16155bfdf72_280)] | | |
Unless the context requires otherwise, references to “Viatris,” “the Company,” “we,” “us” or “our” in this [removed: 2020] [added: 2021] Form 10-K (defined below) refer to Viatris Inc. and its subsidiaries.
We also have used several other terms in this [removed: 2020] [added: 2021] Form 10-K, most of which are explained or defined below.
| [removed: APIs] [added: API] | | | Active pharmaceutical ingredients | | |
| [removed: BCA] [added: Business Combination Agreement] | | | Business Combination Agreement, dated as of July 29, 2019, as amended from time to time, among Viatris, Mylan, Pfizer and certain of their affiliates | | |
| clean energy investments | | | Used to define the three equity method investments the Company has in limited liability companies that own refined coal production plants whose activities qualify for income tax credits under [added: Section 45 of] the Code | | |
| Combination | | | Refers to Mylan combining with Pfizer's Upjohn Business in a Reverse Morris Trust transaction to form Viatris [added: on November 16, 2020] | | |
| Commercial Paper Program | | | The $1.65 billion unsecured commercial paper program entered into as of November 16, 2020 by Viatris, as issuer, Mylan Inc., Utah Acquisition Sub [added: Inc.] and Mylan II B.V., as guarantors, and certain dealers from time to time | | |
| EPD Business | | | [removed: Prior to the EPD Business Acquisition,] Abbott [removed: Laboratories] [added: Laboratories’] non-U.S. developed markets specialty and branded generics [removed: business] [added: business, prior to its acquisition by Mylan in February 2015] | | |
| Form 10-K | | | This annual report on Form 10-K for the fiscal year ended December 31, [removed: 2020] [added: 2021] | | |
| JANZ segment | | | Viatris’ business segment that includes our operations [removed: primarily] in the following markets: Japan, Australia and New Zealand | | |
| maximum leverage ratio | | | [removed: Under our Revolving Credit Facilty, the] [added: The] maximum consolidated leverage ratio financial covenant requiring maintenance of a maximum ratio of consolidated total indebtedness as of the end of any quarter to consolidated EBITDA for the trailing four quarters as defined in the related credit [removed: agreement] [added: agreements from time to time] | | |
| MPI | | | Mylan [removed: Pharmaceutical] [added: Pharmaceuticals] Inc. | | |
| Mylan II | | | Mylan [removed: II, B.V.;] [added: II B.V.,] a company incorporated under the laws of the Netherlands and an indirect wholly owned subsidiary of Viatris, in which legacy Mylan merged with and into | | |
| NHS | | | [removed: Nation] [added: National] Health Services | | |
| ITEM 4. | | | [Mine Safety Disclosures](#ie2fdfbf3ed474f27b20ef16155bfdf72_1099511630152) | | | [52](#ie2fdfbf3ed474f27b20ef16155bfdf72_1099511630152) | | |
| ITEM 6. | | | [\[Reserved\]](#ie2fdfbf3ed474f27b20ef16155bfdf72_2199023257942) | | | [54](#ie2fdfbf3ed474f27b20ef16155bfdf72_2199023257942) | | |
| ITEM 9C. | | | [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](#ie2fdfbf3ed474f27b20ef16155bfdf72_1099511630180) | | | [148](#ie2fdfbf3ed474f27b20ef16155bfdf72_1099511630180) | | |
| [Signatures](#ie2fdfbf3ed474f27b20ef16155bfdf72_283) | | | | | | [159](#ie2fdfbf3ed474f27b20ef16155bfdf72_283) | | |
Some amounts in this Form 10-K may not add due to rounding.
| 2020 Revolving Facility | | | The revolving credit facility available pursuant to the revolving credit agreement, dated as of June 16, 2020, by and among Viatris, certain lenders and issuing banks from time to time party thereto and Bank of America, N.A., as administrative agent and repaid in full in July 2021 | | |
| 2021 Revolving Facility | | | The $4.0 billion revolving facility dated as of July 1, 2021, by and among Viatris, certain lenders and issuing banks from time to time party thereto and Bank of America, N.A., as administrative agent | | |
| Biocon | | | Biocon Limited | | |
| Biocon Biologics | | | Biocon Biologics Limited, a majority owned subsidiary of Biocon | | |
| Biocon Biologics Transaction | | | The pending transaction between Viatris and Biocon Biologics pursuant to which Viatris will contribute its biosimilar products and programs to Biocon Biologics in exchange for cash consideration and a convertible preferred equity interest in Biocon Biologics | | |
| Biocon Agreement | | | The agreement between Viatris and Biocon Biologics, dated February 28, 2022, relating to the Biocon Biologics Transaction | | |
| Biogen | | | Biogen MA Inc. and Biogen International GmbH, collectively | | |
| ERP system | | | Enterprise resource planning system | | |
| Exchange Offer | | | The offer to exchange the Unregistered Upjohn U.S. Dollar Notes for the Registered Upjohn Notes, which was conducted pursuant to a registration statement filed with the SEC in September 2021 by Viatris Inc., Mylan Inc., Mylan II B.V. and Utah Acquisition Sub Inc. and declared effective on September 28, 2021. The exchange offer expired on October 28, 2021 and settled on October 29, 2021. | | |
| Lilly | | | Eli Lilly and Company | | |
| Mylan Inc. Euro Notes | | | The 2.125% Senior Notes due 2025 issued by Mylan Inc., which are fully and unconditionally guaranteed on a senior unsecured basis by Mylan II B.V., Viatris Inc. and Utah Acquisition Sub Inc. | | |
| Mylan Inc. U.S. Dollar Notes | | | The 4.200% Senior Notes due 2023, 3.125% Senior Notes due 2023, 4.550% Senior Notes due 2028, 5.400% Senior Notes due 2043 and 5.200% Senior Notes due 2048 issued by Mylan Inc., which are fully and unconditionally guaranteed on a senior unsecured basis by Mylan II B.V., Viatris Inc. and Utah Acquisition Sub Inc. | | |
| NCDs | | | noncommunicable diseases | | |
| Plan | | | Viatris Inc. 2020 Stock Incentive Plan | | |
| PMS | | | Pharmascience Inc. | | |
| Profit Sharing 401(k) Plan | | | 401(k) retirement plan with a profit sharing component for non-union represented employees | | |
| Registered Upjohn Notes | | | The 1.125% Senior Notes due 2022, 1.650% Senior Notes due 2025, 2.300% Senior Notes due 2027, 2.700% Senior Notes due 2030, 3.850% Senior Notes due 2040 and 4.000% Senior Notes due 2050 originally issued on October 29, 2021 registered with the SEC in exchange for the corresponding Unregistered Upjohn U.S. Dollar Notes in a similar aggregate principal amount and with terms substantially identical to the corresponding Unregistered Upjohn U.S. Dollar Notes and fully and unconditionally guaranteed by Mylan Inc., Mylan II and Utah Acquisition Sub Inc. | | |
| restricted stock awards | | | The Company’s nonvested restricted stock and restricted stock unit awards, including PSUs | | |
| Senior U.S. Dollar Notes | | | The Registered Upjohn U.S. Dollar Notes, the Utah U.S. Dollar Notes and the Mylan Inc. U.S. Dollar Notes, collectively | | |
| Separation and Distribution Agreement | | | Separation and Distribution Agreement between Viatris and Pfizer, dated as of July 29, 2019, as amended from time to time | | |
| Stock awards | | | Stock options and SARs | | |
| Unregistered Upjohn U.S. Dollar Notes | | | The 1.125% Senior Notes due 2022, 1.650% Senior Notes due 2025, 2.300% Senior Notes due 2027, 2.700% Senior Notes due 2030, 3.850% Senior Notes due 2040 and 4.000% Senior Notes due 2050 originally issued on June 22, 2020 by Upjohn Inc. (now Viatris Inc.) in a private offering exempt from the registration requirements of the Securities Act and fully and unconditionally guaranteed by Mylan Inc., Mylan II and Utah Acquisition Sub Inc. | | |
| USD Term Loan Facility | | | The $600 million delayed draw term loan credit agreement, dated as of June 16, 2020 by and among Viatris, Mizuho Bank, Ltd. and MUFG Bank, Ltd., as administrative agent, and repaid in full in July 2021 | | |
| | | | | | |
| --- | --- | --- | --- | --- | --- |
| Utah Euro Notes | | | The 2.250% Senior Notes due 2024 and 3.125% Senior Notes due 2028 issued by Utah Acquisition Sub Inc., which are fully and unconditionally guaranteed on a senior unsecured basis by Mylan Inc., Viatris Inc. and Mylan II B.V. | | |
| Utah U.S. Dollar Notes | | | The 3.950% Senior Notes due 2026 and 5.250% Senior Notes due 2046 issued by Utah Acquisition Sub Inc., which are fully and unconditionally guaranteed on a senior unsecured basis by Mylan Inc., Viatris Inc. and Mylan II B.V. | | |
| WHO | | | World Health Organization | | |
| YEN Term Loan Facility | | | The ¥40 billion term loan agreement dated as of July 1, 2021, by and among Viatris, Mizuho Bank, Ltd. and MUFG Bank, Ltd., as administrative agent | | |
| ITEM 6. | | | [Selected Financial Data](#i813891f659a548d0a222b7186f884e88_100) | | | [49](#i813891f659a548d0a222b7186f884e88_100) | | |
| [Signatures](#i813891f659a548d0a222b7186f884e88_292) | | | | | | [168](#i813891f659a548d0a222b7186f884e88_292) | | |
| 2014 Program | | | One-Time Special Performance-Based Five-Year Realizable Value Incentive Program adopted in February 2014 | | |
| Abbott | | | Abbott Laboratories | | |
| Amgen | | | Amgen Inc. and Amgen Manufacturing Limited | | |
| AMP | | | Average Manufacturer Price | | |
| BIAM | | | Biosimilar Initial Advisory Meeting | | |
| Biocon | | | Biocon Ltd. | | |
| CAT | | | Competition Appeals Tribunal | | |
| CCPA | | | California Consumer Privacy Act of 2018 | | |
| CNS | | | Central Nervous System | | |
| DCGI | | | Drug Controller General of India | | |
| EPD Business Acquisition | | | Mylan N.V.'s acquisition of Mylan Inc. and the EPD Business on February 27, 2015 | | |
| The Facility | | | The Novartis TOBI Podhaler® production facility in San Carlos, California | | |
| Finco | | | Upjohn Finance B.V., a wholly owned financing subsidiary of Viatris | | |
| GUK | | | Generics \[U.K.\] Limited | | |
| HMOs | | | Health maintenance organizations | | |
| HSR Act | | | Hart-Scott-Rodino Antitrust Improvements Act of 1976 | | |
| Legacy Mylan Inc. Notes | | | The senior unsecured notes previously issued by Mylan Inc. and guaranteed by Mylan | | |
| Legacy Mylan Notes | | | The Legacy Mylan Inc. Notes, together with the Legacy Mylan N.V. Notes | | |
| Legacy Mylan N.V. Notes | | | The senior unsecured notes previously issued by Mylan and guaranteed by Mylan Inc. | | |
| Mylan Supplemental Indentures | | | Supplemental indentures enteredin to by Viatris, Utah Acquisition Sub, Mylan II and Mylan Inc. on November 16, 2020 to assume and provide full and uncondtioanl guarantees of the Legacy Mylan Notes | | |
| Novartis | | | Novartis AG | | |
| Revance Collaboration Agreement | | | A collaboration agreement in which the Company and Revance will collaborate exclusively, on a world-wide basis (excluding Japan), to develop, manufacture and commercialize a biosimilar to the branded biologic product (onabotulinumtoxinA) marketed as BOTOX® | | |
| Strides Arcolab | | | Strides Arcolab Limited | | |
| Term Loan Agreement | | | A $600 million delayed draw term loan agreement Viatris entered into in June 2020 | | |
| 2016 Term Facility | | | Term credit facility entered into on November 22, 2016 among Mylan N.V., as borrower, Mylan Inc., as a guarantor, certain lenders and Goldman Sachs Bank USA, as administrative agent | | |
| Viatris Supplemental Indentures | | | Supplemental indentures entered into by Viatris, Upjohn Finance B.V., Utah Acquisition Sub, Mylan II, and Mylan Inc. on November 16, 2020, to provide for full and unconditional guarantees of the Upjohn Senior Notes by Utah Acquisition Sub, Mylan II and Mylan Inc. | | |
An excerpt. Shown here: 40 of 41 rewritten, all 34 added and all 28 removed. The counts are complete. For every sentence, read Cover and table of contents in the FY2021 filing and the FY2020 filing.
Item 4. Mine Safety Disclosures
0 rewritten, 2 added, 0 removed, 0 unchanged
New section this year
Not applicable.
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
13 rewritten, 7 added, 7 removed, 9 unchanged
As of February 22, 2021, there were approximately [removed: 118,297] [added: 113,007] holders of record of shares of Viatris common stock.
[removed: These notes] [added: The Unregistered Upjohn U.S. Dollar Notes] were issued in a private offering exempt from the registration requirements of the Securities Act, to qualified institutional buyers in accordance with Rule 144A under the Securities Act and to persons outside of the U.S. pursuant to Regulation S under the Securities Act.
In [removed: November 2018, Mylan N.V. and Mylan Inc.] [added: September 2021, Viatris] filed a registration statement with the SEC with respect to an offer to exchange [removed: these notes for registered notes] [added: up to $7.45 billion aggregate principal amount of Unregistered Upjohn U.S. Dollar Notes] with [added: Registered Upjohn Notes in] the same aggregate principal amount and [added: with] terms substantially identical in all material respects, which was declared effective on [removed: December 11, 2018.][added: September 28, 2021.]
The exchange offer expired on [removed: January 9, 2019] [added: October 28, 2021] and settled on [removed: January 10, 2019.][added: October 29, 2021.]
In June 2020, Upjohn issued $7.45 billion aggregate principal amount of senior unsecured debt securities, comprised of 1.125% Senior Notes due 2022, 1.650% Senior Notes due 2025, 2.300% Senior Notes due 2027, 2.700% Senior Notes due 2030, 3.850% Senior Notes due 2040 and 4.000% Senior Notes due [removed: 2050.][added: 2050 (collectively, the “Unregistered Upjohn U.S. Dollar Notes”).]
In June 2020, Upjohn Finance B.V., a wholly owned financing subsidiary of Upjohn, issued [removed: €3.6] [added: €3.60] billion aggregate principal amount of senior unsecured debt securities, comprised of 0.816% Senior Notes due 2022, 1.023% Senior Notes due 2024, 1.362% Senior Notes due 2027 and 1.908% Senior Notes due 2032.
The graph below [removed: matches] [added: compares] Viatris [removed: Inc.'s] [added: Inc.’s] cumulative total shareholder return on common stock with the cumulative total returns of the S&P 500 index and the Dow Jones US Pharmaceuticals index.
The graph tracks the performance of a $100 investment in our common stock and in each index (with the reinvestment of all dividends) from November 16, 2020 to December 31, [removed: 2020.][added: 2021.]
[removed: ][added: ]
| | | | November 16, 2020 | | | | | | [removed: | | | | | | | | | | | | | | | | | |] [added: December 31, 2020] | | | | | | December 31, [removed: 2020] [added: 2021] | | |
| Viatris Inc. | | | 100.00 | | | | | | [removed: | | | | | | | | | | | | | | | | | |] [added: 118.20] | | | | | | [removed: 118.20] [added: 87.32] | | |
| S&P 500 | | | 100.00 | | | | | | [removed: | | | | | | | | | | | | | | | | | |] [added: 115.21] | | | | | | [removed: 115.21] [added: 148.28] | | |
| Dow Jones U.S. Pharmaceuticals | | | 100.00 | | | | | | [removed: | | | | | | | | | | | | | | | | | |] [added: 113.12] | | | | | | [removed: 113.12] [added: 141.38] | | |
The Company paid quarterly cash dividends of $0.11 per share on the Company’s issued and outstanding common stock on June 16, 2021, September 16, 2021 and December 16, 2021.
On January 4, 2022, the Company’s Board of Directors declared a quarterly cash dividend of $0.12 per share on the Company’s issued and outstanding common stock, which will be payable on March 16, 2022 to shareholders of record as of the close of business on February 24, 2022.
The declaration and payment of future dividends to holders of the Company’s common stock will be at the discretion of the Board of Directors, and will depend upon factors, including but not limited to, the Company’s financial condition, earnings, capital requirements of its businesses, legal requirements, regulatory constraints, industry practice, and other factors that the Board of Directors deems relevant.
The Company did not pay any dividends in 2020.
More than 99.9% of the aggregate principal amount of the Unregistered Upjohn U.S. Dollar Notes were exchanged for Registered Upjohn Notes.
| | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
The Company did not pay dividends in 2020 or 2019, but intends to initiate a dividend on its common stock in 2021.
In April 2018, Mylan Inc. issued $1.5 billion aggregate principal amount of senior unsecured debt securities, comprised of 4.550% Senior Notes due 2028 and 5.200% Senior Notes due 2048.
100% of each of the 4.550% Senior Notes due 2028 and the 5.200% Senior Notes due 2048 were exchanged.
In May 2018, Mylan Inc. issued €500 million aggregate principal amount of senior unsecured debt securities, comprised of 2.125% Euro Senior Notes due 2025.
These notes were issued in a private offering exempt from the registration requirements of the Securities Act, to persons outside of the U.S. pursuant to Regulation S under the Securities Act.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
Item 6. [Reserved]
0 rewritten, 0 added, 39 removed, 0 unchanged
The selected consolidated financial data set forth below should be read in conjunction with “Management’s Discussion and Analysis of Results of Operations and Financial Condition” included in Part II.
Item 7 of this Form 10-K and the consolidated financial statements and related notes to consolidated financial statements included in Part II.
Item 8 of this Form 10-K.
In accordance with *ASC 805, Business Combinations*, Mylan is considered the accounting acquirer of the Upjohn Business and all historical financial information prior to November 16, 2020 represents Mylan’s historical results.
The functional currency of the primary economic environment in which the operations of Viatris and its subsidiaries in the U.S. are conducted is the U.S. Dollar.
The functional currency of non-U.S. subsidiaries is generally the local currency in the country in which each subsidiary operates.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Year Ended December 31, | | | | | | | | | | | | | | | | | | | | | | | | | | |
| (In millions, except per share amounts) | | | 2020 | | | | | | 2019 | | | | | | 2018 | | | | | | 2017 | | | | | | 2016 | | |
| Statements of Operations: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Total revenues | | | $ | 11,946.0 | | | | | $ | 11,500.5 | | | | | $ | 11,433.9 | | | | | $ | 11,907.7 | | | | | $ | 11,076.9 | |
| Cost of sales | | | 8,149.3 | | | | | | 7,602.9 | | | | | | 7,432.3 | | | | | | 7,124.6 | | | | | | 6,379.9 | | |
| Gross profit | | | 3,796.7 | | | | | | 3,897.6 | | | | | | 4,001.6 | | | | | | 4,783.1 | | | | | | 4,697.0 | | |
| Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Research and development | | | 555.1 | | | | | | 639.9 | | | | | | 704.5 | | | | | | 783.3 | | | | | | 826.8 | | |
| Selling, general and administrative | | | 3,344.6 | | | | | | 2,563.6 | | | | | | 2,441.0 | | | | | | 2,575.7 | | | | | | 2,498.5 | | |
| Litigation settlements and other contingencies, net | | | 107.8 | | | | | | (21.4) | | | | | | (49.5) | | | | | | (13.1) | | | | | | 672.5 | | |
| Total operating expenses | | | 4,007.5 | | | | | | 3,182.1 | | | | | | 3,096.0 | | | | | | 3,345.9 | | | | | | 3,997.8 | | |
| (Loss) Earnings from operations | | | (210.8) | | | | | | 715.5 | | | | | | 905.6 | | | | | | 1,437.2 | | | | | | 699.2 | | |
| Interest expense | | | 497.8 | | | | | | 517.3 | | | | | | 542.3 | | | | | | 534.6 | | | | | | 454.8 | | |
| Other expense (income), net | | | 12.6 | | | | | | 43.8 | | | | | | 64.9 | | | | | | (0.4) | | | | | | 122.7 | | |
| (Loss) Earnings before income taxes | | | (721.2) | | | | | | 154.4 | | | | | | 298.4 | | | | | | 903.0 | | | | | | 121.7 | | |
| Income tax (benefit) provision | | | (51.3) | | | | | | 137.6 | | | | | | (54.1) | | | | | | 207.0 | | | | | | (358.3) | | |
| Net (loss) earnings attributable to Viatris Inc. shareholders | | | $ | (669.9) | | | | | $ | 16.8 | | | | | $ | 352.5 | | | | | $ | 696.0 | | | | | $ | 480.0 | |
| Earnings (loss) per share attributable to Viatris Inc. shareholders | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Basic | | | $ | (1.11) | | | | | $ | 0.03 | | | | | $ | 0.69 | | | | | $ | 1.30 | | | | | $ | 0.94 | |
| Diluted | | | $ | (1.11) | | | | | $ | 0.03 | | | | | $ | 0.68 | | | | | $ | 1.30 | | | | | $ | 0.92 | |
| Weighted average shares outstanding: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Basic | | | 601.2 | | | | | | 515.7 | | | | | | 514.5 | | | | | | 534.5 | | | | | | 513.0 | | |
| Diluted | | | 601.2 | | | | | | 516.5 | | | | | | 516.5 | | | | | | 536.7 | | | | | | 520.5 | | |
| Selected Balance Sheet data: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Total assets | | | $ | 61,553.0 | | | | | $ | 31,255.5 | | | | | $ | 32,734.9 | | | | | $ | 35,806.3 | | | | | $ | 34,726.2 | |
| Working capital (1) | | | 2,304.6 | | | | | | 1,188.2 | | | | | | 1,779.9 | | | | | | 828.0 | | | | | | 2,481.8 | | |
| Short-term borrowings | | | 1,100.9 | | | | | | — | | | | | | 1.9 | | | | | | 46.5 | | | | | | 46.4 | | |
| Long-term debt, including current portion of long-term debt | | | 24,685.5 | | | | | | 12,671.9 | | | | | | 13,816.4 | | | | | | 14,614.5 | | | | | | 15,426.2 | | |
| Total equity | | | 22,954.1 | | | | | | 11,883.8 | | | | | | 12,167.1 | | | | | | 13,307.6 | | | | | | 11,117.6 | | |
____________
(1) Working capital is calculated as current assets minus current liabilities.
Item 8. Financial Statements And Supplementary Data
773 rewritten, 315 added, 397 removed, 1,180 unchanged
| [Management’s Report on Internal Control over Financial [removed: Reporting](#i813891f659a548d0a222b7186f884e88_145)] [added: Reporting](#ie2fdfbf3ed474f27b20ef16155bfdf72_145)] | | | [removed: [81](#i813891f659a548d0a222b7186f884e88_145)] [added: [79](#ie2fdfbf3ed474f27b20ef16155bfdf72_145)] | | |
| [Reports of Independent Registered Public Accounting [removed: Firm](#i813891f659a548d0a222b7186f884e88_148)] [added: Firm](#ie2fdfbf3ed474f27b20ef16155bfdf72_148) [](#ie2fdfbf3ed474f27b20ef16155bfdf72_148) (PCAOB ID No. 34)] | | | [removed: [82](#i813891f659a548d0a222b7186f884e88_148)] [added: [80](#ie2fdfbf3ed474f27b20ef16155bfdf72_148)] | | |
| [Consolidated Balance Sheets as of December 31, [removed: 2020 and 2019](#i813891f659a548d0a222b7186f884e88_154)] [added: 202](#ie2fdfbf3ed474f27b20ef16155bfdf72_154)[1](#ie2fdfbf3ed474f27b20ef16155bfdf72_154) [and 20](#ie2fdfbf3ed474f27b20ef16155bfdf72_154)[20](#ie2fdfbf3ed474f27b20ef16155bfdf72_154)] | | | [removed: [87](#i813891f659a548d0a222b7186f884e88_154)] [added: [84](#ie2fdfbf3ed474f27b20ef16155bfdf72_154)] | | |
| [Consolidated Statements of Operations for the Years Ended December 31, [removed: 20](#i813891f659a548d0a222b7186f884e88_160)[20, 20](#i813891f659a548d0a222b7186f884e88_160)[19,](#i813891f659a548d0a222b7186f884e88_160) [and](#i813891f659a548d0a222b7186f884e88_160) [2018](#i813891f659a548d0a222b7186f884e88_160)] [added: 202](#ie2fdfbf3ed474f27b20ef16155bfdf72_157)[1](#ie2fdfbf3ed474f27b20ef16155bfdf72_157)[, 20](#ie2fdfbf3ed474f27b20ef16155bfdf72_157)[20](#ie2fdfbf3ed474f27b20ef16155bfdf72_157)[, and 201](#ie2fdfbf3ed474f27b20ef16155bfdf72_157)[9](#ie2fdfbf3ed474f27b20ef16155bfdf72_157)] | | | [removed: [88](#i813891f659a548d0a222b7186f884e88_160)] [added: [85](#ie2fdfbf3ed474f27b20ef16155bfdf72_157)] | | |
| [Consolidated Statements of Comprehensive (Loss) Earnings for the Years Ended December 31, [removed: 20](#i813891f659a548d0a222b7186f884e88_163)[20](#i813891f659a548d0a222b7186f884e88_163)[, 201](#i813891f659a548d0a222b7186f884e88_163)[9](#i813891f659a548d0a222b7186f884e88_163)] [added: 202](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)[1](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)[, 20](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)[2](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)[0](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)] [and [removed: 20](#i813891f659a548d0a222b7186f884e88_163)[18](#i813891f659a548d0a222b7186f884e88_163)] [added: 201](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)[9](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)] | | | [removed: [89](#i813891f659a548d0a222b7186f884e88_163)] [added: [86](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)] | | |
| [Consolidated Statements of Equity for the Years Ended December 31, [removed: 20](#i813891f659a548d0a222b7186f884e88_166)[20](#i813891f659a548d0a222b7186f884e88_166)[, 201](#i813891f659a548d0a222b7186f884e88_166)[9](#i813891f659a548d0a222b7186f884e88_166)] [added: 202](#ie2fdfbf3ed474f27b20ef16155bfdf72_163)[1](#ie2fdfbf3ed474f27b20ef16155bfdf72_163)[, 20](#ie2fdfbf3ed474f27b20ef16155bfdf72_163)[20](#ie2fdfbf3ed474f27b20ef16155bfdf72_163)] [and [removed: 201](#i813891f659a548d0a222b7186f884e88_166)[8](#i813891f659a548d0a222b7186f884e88_166)] [added: 201](#ie2fdfbf3ed474f27b20ef16155bfdf72_163)[9](#ie2fdfbf3ed474f27b20ef16155bfdf72_163)] | | | [removed: [90](#i813891f659a548d0a222b7186f884e88_166)] [added: [87](#ie2fdfbf3ed474f27b20ef16155bfdf72_163)] | | |
| [Consolidated Statements of Cash Flows for the Years Ended December 31, [removed: 20](#i813891f659a548d0a222b7186f884e88_169)[20](#i813891f659a548d0a222b7186f884e88_169)[, 201](#i813891f659a548d0a222b7186f884e88_169)[9](#i813891f659a548d0a222b7186f884e88_169)] [added: 202](#ie2fdfbf3ed474f27b20ef16155bfdf72_166)[1](#ie2fdfbf3ed474f27b20ef16155bfdf72_166)[, 20](#ie2fdfbf3ed474f27b20ef16155bfdf72_166)[20](#ie2fdfbf3ed474f27b20ef16155bfdf72_166)] [and [removed: 201](#i813891f659a548d0a222b7186f884e88_169)[8](#i813891f659a548d0a222b7186f884e88_169)] [added: 201](#ie2fdfbf3ed474f27b20ef16155bfdf72_166)[9](#ie2fdfbf3ed474f27b20ef16155bfdf72_166)] | | | [removed: [91](#i813891f659a548d0a222b7186f884e88_169)] [added: [88](#ie2fdfbf3ed474f27b20ef16155bfdf72_166)] | | |
| [Notes to Consolidated Financial [removed: Statements](#i813891f659a548d0a222b7186f884e88_172)] [added: Statements](#ie2fdfbf3ed474f27b20ef16155bfdf72_169)] | | | [removed: [92](#i813891f659a548d0a222b7186f884e88_172)] [added: [89](#ie2fdfbf3ed474f27b20ef16155bfdf72_169)] | | |
As a result of this assessment, management has concluded that the Company maintained effective internal control over financial reporting as of December 31, [removed: 2020] [added: 2021] based on the criteria in *Internal Control - Integrated Framework (2013)* issued by COSO.
Our independent registered public accounting firm, Deloitte & Touche [removed: LLP,] [added: LLP (PCAOB ID No. 34),] has audited the effectiveness of the Company’s internal control over financial reporting.
Deloitte & Touche LLP’s opinion on the Company’s internal control over financial reporting appears on page [removed: 86] [added: 83] of this Annual Report on Form 10-K.
[removed: To] [added: To] the shareholders and the Board of Directors of Viatris [removed: Inc.:][added: Inc.:]
We have audited the accompanying consolidated balance sheets of [removed: Viatris,] [added: Viatris] Inc. and subsidiaries (the "Company") as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] the related consolidated statements of operations, comprehensive (loss) earnings, equity, and cash [removed: flows] [added: flows,] for each of the three years in the period ended December 31, [removed: 2020,] [added: 2021,] and the related notes and the [removed: consolidated financial statement] schedule listed in the Index at Item 15 (collectively referred to as the "financial statements").
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2020,] [added: 2021,] in conformity with accounting principles generally accepted in the United States of America.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, [removed: 2020,] [added: 2021,] based on criteria established in *Internal Control [removed: -] [added: —] Integrated Framework (2013)* issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated [removed: March 1, 2021,] [added: February 28, 2022,] expressed an unqualified opinion on the Company's internal control over financial reporting.
The critical audit matters communicated below are matters arising from the [removed: current period] [added: current-period] audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
Goodwill – [removed: Mylan N.V.] [added: Viatris Inc.] Europe [added: and JANZ] Reporting [removed: Unit] [added: Units] – Refer to Note 8 to the financial statements.
The Company [removed: has] performed [removed: an interim goodwill impairment test and] its annual goodwill impairment test as of [removed: March 31 and] April 1, [removed: 2020, respectively.][added: 2021.]
As of [removed: March 31, 2020 and] April 1, [removed: 2020,] [added: 2021,] the Company had [removed: $9.3] [added: $11.91] billion of consolidated goodwill, [removed: $4.43] [added: $5.15] billion [added: and $0.82 billion] of which was allocated to the [removed: Mylan N.V.] [added: Viatris Inc.] Europe [removed: reporting unit (“Europe] [added: and JANZ] reporting [removed: unit”).][added: units, respectively.]
The Company performed its valuation analysis, using both income and market-based approaches, to determine the fair value of its Europe [added: and JANZ] reporting [removed: unit.][added: units.]
These estimates and assumptions, utilizing Level 3 [added: valuation] inputs, primarily include, but are not limited to, market multiples, control premiums, [removed: the] discount [removed: rate,] [added: rates,] terminal growth rates, operating income before depreciation and amortization, and capital expenditures forecasts.
[removed: The fair value of] [added: For] the Europe reporting [removed: unit] [added: unit, the estimated fair value] exceeded its carrying value by approximately [removed: $1.2 billion,] [added: $0.91 billion] or [removed: 11%, as of March 31 and April 1, 2020 and, therefore, no] [added: 5.8% for the annual goodwill] impairment [removed: was recognized.][added: test.]
Given that the Europe [added: and JANZ] reporting unit’s revenues are sensitive to changes in consumer demand, the approval of new product launches, the expansion of existing products into new jurisdictions (which have differentiated distribution and commercialization models throughout the [removed: region),] [added: regions),] and the impact of business development activity, auditing management’s judgments regarding forecasts of future revenues, and the selection of the discount [removed: rate] [added: rates] and terminal growth [removed: rate] [added: rates] required a high degree of auditor judgment and an increased extent of effort, including the need to involve our fair value specialists.
Our audit procedures related to the forecasts of future revenues (“forecasts”), and the selection of the discount [removed: rate] [added: rates] and terminal growth [removed: rate] [added: rates] for the Europe [added: and the JANZ] reporting [removed: unit] [added: units] included the [removed: following,] [added: following procedures,] among others:
- We tested the effectiveness of controls over the review of the goodwill impairment [removed: tests,] [added: test,] including those over the development of the business forecasts of future revenues and the selection of the discount [removed: rate] [added: rates] and terminal growth [removed: rate.][added: rates.]
- We evaluated management’s ability to accurately forecast future revenues of the Europe [added: and JANZ] reporting [removed: unit] [added: units] by comparing actual results to management’s historical forecasts.
We also considered third party reports related to macroeconomic and industry [removed: trends,] [added: trends] and made inquiries of management, including various regional commercial and operations [removed: leaders,] [added: leaders] to assess key inputs in the forecast assumptions.
- With the assistance of our fair value specialists, we evaluated the reasonableness of the valuation methodology, discount [removed: rate,] [added: rates,] and terminal growth [removed: rate,] [added: rates,] including (1) testing the source information underlying the determination of the discount [removed: rate] [added: rates] and terminal growth [removed: rate] [added: rates] and the mathematical accuracy of the calculations, (2) developing a range of independent estimates and comparing those to the discount rates selected by management, and (3) considering third party macroeconomic reports.
The Company has agreements with certain indirect customers, such as independent pharmacies, retail pharmacy chains, managed care organizations, hospitals, nursing homes, governmental [removed: agencies] [added: agencies,] and pharmacy benefit managers, which establish contract prices for certain products.
The chargeback accrual recorded at MPI represents the majority of the global chargeback reserve as of December 31, [removed: 2020.][added: 2021.]
- We developed independent expectations of product-level chargeback accruals and chargeback accruals in the aggregate using the [removed: following;] [added: following:] 1) customer contracts, 2) historical sales and chargeback activity, 3) third-party channel inventory for select wholesalers, and 4) credits subsequently issued to period end and compared those to the recorded amounts.
The returns reserve at MPI represents a significant component of the global sales returns reserve as of December 31, [removed: 2020.][added: 2021.]
We have audited the internal control over financial reporting of Viatris, Inc. and subsidiaries (the “Company”) as of December 31, [removed: 2020,] [added: 2021,] based on criteria established in *Internal Control - Integrated Framework (2013)* issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2020,] [added: 2021,] based on criteria established in [removed: *Internal] [added: Internal] Control - Integrated Framework [removed: (2013)*] [added: (2013)] issued by COSO.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, [removed: 2020,] [added: 2021,] of the Company and our report dated [removed: March 1, 2021,] [added: February 28, 2022,] expressed an unqualified opinion on those financial statements.
| | | | [removed: December 31, 2020] | | | | | | [removed: December 31, 2019] [added: 2020] | | | [added: | | | 2019 | | |]
| Cash and cash equivalents | | | $ | [added: 701.2 | | | | | $ |] 844.4 | | | | | $ | 475.6 | |
| Accounts receivable, net | | | [removed: 4,843.8] [added: 4,266.4] | | | | | | [removed: 3,058.8] [added: 4,843.8] | | |
| Inventories | | | [removed: 5,471.9] [added: 3,977.7] | | | | | | [removed: 2,670.9] [added: 5,471.9] | | |
| Prepaid expenses and other current assets | | | [removed: 1,707.4] [added: 1,957.6] | | | | | | [removed: 552.0] [added: 1,707.4] | | |
The fair values of the Europe and the JANZ reporting units exceeded their carrying values by approximately $0.91 billion, or 5.8%, and $0.23 billion, or 7.0%, respectively, as of April 1, 2021 and, therefore, no impairments were recognized.
February 28, 2022
February 28, 2022
| Common stock: $0.01 par value, 3,000,000,000 shares authorized; shares issued and outstanding: 1,209,507,463 and 1,206,895,644, respectively | | | 12.1 | | | | | | 12.1 | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Net loss | | | — | | | | | | $ | — | | | | | $ | — | | | | | $ | (1,269.1) | | | | | — | | | | | | $ | — | | | | | $ | — | | | | | | | | | | | $ | (1,269.1) | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cash dividends declared, $0.33 per common share | | | — | | | | | | — | | | | | | — | | | | | | (403.3) | | | | | | — | | | | | | — | | | | | | — | | | | | | | | | | | | (403.3) | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Balance at December 31, 2021 | | | 1,209,507,463 | | | | | | $ | 12.1 | | | | | $ | 18,536.1 | | | | | $ | 3,688.8 | | | | | — | | | | | | $ | — | | | | | $ | (1,744.3) | | | | | | | | | | | $ | 20,492.7 | | | | |
| Cash dividends paid | | | (399.0) | | | | | | — | | | | | | — | | |
Improving the ability of patients to gain access to sustainable and high-quality healthcare is our relentless pursuit.
One that rests on visionary thinking, determination and best-in-class capabilities that were strategically built to remove barriers across the health spectrum and advance access globally.
| Net (loss) earnings attributable to Viatris Inc. common shareholders | | | $ | (1,269.1) | | | | | $ | (669.9) | | | | | $ | 16.8 | |
| Weighted average shares outstanding | | | 1,208.8 | | | | | | 601.2 | | | | | | 515.7 | | |
The Company paid quarterly cash dividends of $0.11 per share on the Company’s issued and outstanding common stock on June 16, 2021, September 16, 2021, and December 16, 2021.
On January 4, 2022, the Company’s Board of Directors declared a quarterly cash dividend of $0.12 per share on the Company’s issued and outstanding common stock, which will be payable on March 16, 2022 to shareholders of record as of the close of business on February 24, 2022.
The declaration and payment of future dividends to holders of the Company’s common stock will be at the discretion of the Board of Directors, and will depend upon factors, including but not limited to, the Company’s financial condition, earnings, capital requirements of its businesses, legal requirements, regulatory constraints, industry practice, and other factors that the Board of Directors deems relevant.
On February 28, 2022, the Company announced that its Board of Directors had authorized a share repurchase program for the repurchase of up to $1.0 billion of the Company’s shares of common stock.
The Company has not yet repurchased any shares of common stock under the share repurchase program and the share repurchase program does not obligate the Company to acquire any particular amount of common stock.
In October 2021, the FASB issued Accounting Standards Update 2021-08, *Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers* (“ASU 2021-08”), which requires entities (acquirers) to recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with ASC Topic 606.
In November 2021, the FASB issued Accounting Standards Update 2021-10, *Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance* (“ASU 2021-10”), which requires entities to provide annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy.
3.Revenue Recognition and Accounts Receivable
| Brands | | | 5,759.2 | | | | | | 2,207.8 | | | | | | 1,197.1 | | | | | | 1,677.2 | | | | | | 10,841.3 | | |
| Complex Gx and Biosimilars | | | 1,241.6 | | | | | | 0.2 | | | | | | 46.5 | | | | | | 53.8 | | | | | | 1,342.1 | | |
| Generics | | | 3,427.9 | | | | | | 4.8 | | | | | | 783.8 | | | | | | 1,413.7 | | | | | | 5,630.2 | | |
| Total Viatris | | | $ | 10,428.7 | | | | | $ | 2,212.8 | | | | | $ | 2,027.4 | | | | | $ | 3,144.7 | | | | | $ | 17,813.6 | |
The following table presents net sales on a consolidated basis for select key products for the year ended December 31, 2021:
| | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | | | | | | | | | |
| Select Key Global Products | | | | | | | | | | | | | | |
Supplementary Financial Information
| | | | | | |
| --- | --- | --- | --- | --- | --- |
| [Supplementary Financial Information](#i813891f659a548d0a222b7186f884e88_256) | | | [157](#i813891f659a548d0a222b7186f884e88_256) | | |
On November 16, 2020, the combination of Mylan and the Upjohn Business was completed, with Mylan considered the accounting acquirer of the Upjohn Business.
The Upjohn Business represented 7% of the Company’s consolidated total revenues for the year ended December 31, 2020, and assets (including intangible assets and goodwill) represented 48% of the Company’s consolidated total assets, as of December 31, 2020.
Management did not include the Upjohn Business when conducting its assessment of the effectiveness of the Company’s internal control over financial reporting as of December 31, 2020.
*Critical Audit Matter Description*
*How the Critical Audit Matter Was Addressed in the Audit*
Upjohn Business Combination Agreement – Refer to Notes 4 and 12 to the financial statements.
Viatris Inc. was formed in November 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer (“the Combination”).
The transaction between Mylan and Viatris involved multiple legal entity restructuring transactions and a reverse merger acquisition with Viatris representing the legal acquirer and Mylan representing the accounting acquirer of the Upjohn Business.
The Company applied the acquisition method to the acquired assets and assumed liabilities of the Upjohn Business.
The preliminary allocation of the purchase price included $18.04 billion of identified intangible assets, which were valued based on company specific information and financial projections which are not observable in the market and are thus considered Level 3 fair value measurements as defined by U.S. GAAP.
In addition, the Company evaluated its tax positions arising from the legal entity restructuring transactions for those positions considered to be more likely than not of being sustained upon audit, based on the technical merits of the position.
Given that the accounting for the transaction required management to make (1) significant judgments related to the accounting acquirer determination, (2) significant estimates and assumptions, in particular those associated with the valuation of the acquired intangible assets, and (3) significant judgments in analyzing and interpreting tax laws and positions across multiple jurisdictions arising from the legal entity restructuring transactions, performing audit procedures to evaluate the accounting for the transaction required a high degree of auditor judgment and an increased extent of effort, including the need to involve our fair value and tax specialists.
Our audit procedures related to the accounting for the transaction included the following, among others:
- We tested the effectiveness of controls related to the transaction, including controls over management’s determination of accounting acquirer, application of the acquisition method, and evaluation of uncertain tax positions.
- We evaluated the determination of the accounting acquirer in the combination with the assistance of our subject matter experts.
- We evaluated the reasonableness of management’s forecasts of future cash flows of the acquired intangible assets by comparing the projections to (1) historical Upjohn results (2) internal communications to management and the Board of Directors, and (3) third party industry reports.
Further, we made inquiries of management, including various regional commercial and operations leaders, to assess key inputs in the forecast assumptions.
- With the assistance of our fair value specialists, we evaluated the reasonableness of the valuation methodology, and we evaluated the reasonableness of the discount rates by:
–Testing the source information underlying the determination of the discount rates and testing the mathematical accuracy of the calculation.
–Developing a range of independent estimates and comparing those to the discount rates selected by management.
- With the assistance of our tax specialists, we evaluated the uncertain tax positions associated with the transaction by:
–Obtaining management’s detailed step-by-step plan of the pre-close and post-close transactions and evaluating whether tax consequences of the transactions are consistent with our interpretation.
–Obtaining copies of technical tax support, including memorandums, and evaluating whether the conclusions reached are reasonable and supportable and consistent with our interpretation.
–Testing the underlying calculations and assumptions used to support reserves related to tax uncertainty.
March 1, 2021
As described in Management’s Report on Internal Control over Financial Reporting, management excluded from its assessment the internal control over financial reporting of the Upjohn Business, which was acquired on November 16, 2020.
The Upjohn Business represented 7% of the Company’s consolidated total revenues for the year ended December 31, 2020 and assets (including intangible assets and goodwill) represented 48% of the Company’s consolidated total assets as of December 31, 2020.
Accordingly, our audit did not include the internal control over financial reporting of the Upjohn Business.
| Common stock — par value $0.01 per share as of December 31, 2020 and ordinary shares — nominal value €0.01 per share as of December 31, 2019 | | | | | | | | | | | |
| Shares authorized: 3,000,000,000 and 1,200,000,000 as of December 31, 2020 and December 31, 2019 | | | | | | | | | | | |
| Shares issued: 1,206,895,644 and 540,746,871 as of December 31, 2020 and December 31, 2019 | | | 12.1 | | | | | | 6.1 | | |
| | | | 22,954.1 | | | | | | 12,883.5 | | |
| Ordinary shares: 24,598,074 as of December 31, 2019 | | | — | | | | | | 999.7 | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
An excerpt. Shown here: 40 of 773 rewritten, 40 of 315 added and 40 of 397 removed. The counts are complete. For every sentence, read Item 8. Financial Statements And Supplementary Data in the FY2021 filing and the FY2020 filing.
Item 9A. Controls and Procedures
3 rewritten, 3 added, 3 removed, 1 unchanged
An evaluation was performed under the supervision and with the participation of the Company’s management, including the Principal Executive Officer and the Principal Financial Officer, of the effectiveness of the design and operation of the Company’s disclosure controls and procedures as of December 31, [removed: 2020.][added: 2021.]
Management’s Report on Internal Control over Financial Reporting is on page [removed: 81,] [added: 79,] which is incorporated herein by reference.
The effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2020] [added: 2021] has been audited by Deloitte & Touche [removed: LLP,] [added: LLP (PCAOB ID No. 34),] an independent registered public accounting firm, as stated in their report on page [removed: 86,] [added: 83,] which is incorporated herein by reference.
During the quarter ended December 31, 2021, the Company continued to transition certain support services from Pfizer, as well as certain subsidiaries, to a new ERP system.
The Company has modified and will continue to modify its internal controls relating to its business and financial processes throughout the transition period, which is expected through the end of calendar year 2022.
While the Company believes that this new system and the related changes to internal controls will ultimately strengthen its internal control over financial reporting, there are inherent risks in implementing any new ERP system and the Company has evaluated and tested control changes in order to provide Management’s Report on Internal Control over Financial Reporting for the year ended December 31, 2021.
On November 16, 2020, the combination of Mylan N.V. and Pfizer's Upjohn Business was completed, with Mylan N.V. considered the accounting acquirer of the Upjohn Business.
The Upjohn Business represented 7% of the Company’s consolidated total revenues for the year ended December 31, 2020, and assets (including intangible assets and goodwill) represented 48% of the Company’s consolidated total assets, as of December 31, 2020.
Management did not include the Upjohn Business when conducting its assessment of the effectiveness of the Company’s internal control over financial reporting as of December 31, 2020.
Item 9B. Other Information
0 rewritten, 0 added, 1 removed, 1 unchanged
PART III
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
0 rewritten, 2 added, 0 removed, 0 unchanged
New section this year
Not applicable.
PART III
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
1 rewritten, 2 added, 2 removed, 7 unchanged
The following table shows information about the securities authorized for issuance under Viatris’ equity compensation plans as of December 31, [removed: 2020:][added: 2021:]
| Equity compensation plans approved by security holders | | | 22,434,618 | | | | | | $ | 20.60 | | | | | 59,591,643 | | |
| Total | | | 22,434,618 | | | | | | $ | 20.60 | | | | | 59,591,643 | | |
| Equity compensation plans approved by security holders | | | 18,785,521 | | | | | | $ | 35.33 | | | | | 68,062,933 | | |
| Total | | | 18,785,521 | | | | | | $ | 35.33 | | | | | 68,062,933 | | |
Item 15. Exhibits, Consolidated Financial Statement Schedules
55 rewritten, 7 added, 2 removed, 155 unchanged
[removed: (1)In 2020, this amount includes] [added: (1)These amounts include] opening balances of the Upjohn Business acquired in the [removed: period.][added: Combination.]
| [removed: [2.2(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520212083/d159300dex991.htm#toc781435_29)] [added: [2.2(a)](http://www.sec.gov/Archives/edgar/data/0001623613/000119312519205031/d775236dex22.htm)] | | | | | | Separation and Distribution Agreement, dated as of July 29, 2019, by and between Pfizer Inc. and Upjohn Inc., [removed: included as Annex C to the Information Statement included] [added: filed] as Exhibit [removed: 99.1] [added: 2.2] to the Report on Form 8-K filed by [removed: Upjohn Inc.] [added: Mylan N.V.] with the SEC on [removed: August 6, 2020,] [added: July 29, 2019,] and incorporated herein by reference.^ | | |
| [removed: [2.2(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520212083/d159300dex991.htm#toc781435_29)] [added: [2.2(c)](http://www.sec.gov/Archives/edgar/data/0001623613/000119312520157416/d830428dex22.htm)] | | | | | | Amendment No. [removed: 1,] [added: 2,] dated as of [removed: February 18,] [added: May 29,] 2020, to the Separation and Distribution Agreement, dated as of July 29, 2019, by and between Pfizer Inc. and Upjohn Inc., [removed: included as Annex D to the Information Statement included] [added: filed] as Exhibit [removed: 99.1] [added: 2.2] to the Report on Form 8-K filed by [removed: Upjohn Inc.] [added: Mylan N.V.] with the SEC on [removed: August 6,] [added: June 1,] 2020, and incorporated herein by reference. [added: ^] | | |
| [removed: [2.2(c)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520212083/d159300dex991.htm#toc781435_29)] [added: [2.2(d)](http://www.sec.gov/Archives/edgar/data/0001792044/000119312520298226/d56774dex26.htm)] | | | | | | Amendment No. [removed: 2,] [added: 3,] dated as of [removed: May 29,] [added: September 18,] 2020, to the Separation and Distribution Agreement, dated as of July 29, 2019, by and between Pfizer Inc. and Upjohn Inc., [removed: included as Annex E to the Information Statement included] [added: filed] as Exhibit [removed: 99.1] [added: 2.6] to the Report on Form 8-K filed by [removed: Upjohn] [added: Viatris] Inc. with the SEC on [removed: August 6,] [added: November 19,] 2020, and incorporated herein by reference. ^ | | |
| [removed: [2.2(d)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520290294/d939086dex21.htm)] [added: [10.38](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex103.htm)] | | | | | | [removed: Amendment No. 3, dated as of September 18, 2020, to the Separation and Distribution] [added: Tax Matters] Agreement, dated as of [removed: July 29, 2019,] [added: November 16, 2020,] by and between Pfizer Inc. and Upjohn Inc., filed as Exhibit [removed: 2.6] [added: 10.3] to the Report on Form 8-K filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. ^ | | |
| [removed: [3.2](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_32-vtrsx20201231x10k.htm)] [added: [3.2](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_32-vtrsx20201231x10k.htm)] | | | | | | Amended and Restated Bylaws of Viatris Inc., effective as of November 16, [removed: 2020.] [added: 2020, filed as Exhibit 3.2 to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.] | | |
| [removed: [4.10](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_410-vtrsx20201231x10k.htm)] [added: [4.10](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_410-vtrsx20201231x10k.htm)] | | | | | | Description of Viatris Inc. Securities Registered Under Section 12 of the Exchange [removed: Act.] [added: Act, filed as Exhibit 4.10 to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.] | | |
| [removed: [10.1(b)](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_101b-vtrsx20201231x10xk.htm)] [added: [10.1(b)](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_101b-vtrsx20201231x10xk.htm)] | | | | | | Form of Make-Whole Restricted Stock Unit Award Agreement under the Viatris 2020 Stock Incentive [removed: Plan.*] [added: Plan, filed as Exhibit 10.1(b) to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.*] | | |
| [removed: [10.1(c)](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_101c-vtrsx20201231x10xk.htm)] [added: [10.1(c)](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_101c-vtrsx20201231x10xk.htm)] | | | | | | Form of Retention Restricted Stock Unit Award Agreement under the Viatris 2020 Stock Incentive [removed: Plan.*] [added: Plan, filed as Exhibit 10.1(c) to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.*] | | |
| [removed: [10.1(d)](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_101d-vtrsx20201231x10xk.htm)] [added: [10.1(d)](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_101d-vtrsx20201231x10xk.htm)] | | | | | | Form of Restricted Stock Unit Award Agreement under the Viatris 2020 Stock Incentive Plan for Michael Goettler and Sanjeev [removed: Narula.*] [added: Narula, filed as Exhibit 10.1(d) to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.*] | | |
| [removed: [10.1(e)](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_101e-vtrsx20201231x10xk.htm)] [added: [10.1(e)](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_101e-vtrsx20201231x10xk.htm)] | | | | | | Value Creation Incentive Award Performance-Based Restricted Stock Unit Award Agreement for Robert J. Coury under the Viatris Inc. 2020 Stock Incentive Plan, effective as of November 23, [removed: 2020.*] [added: 2020, filed as Exhibit 10.1(e) to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.*] | | |
| [removed: [10.2](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_102-vtrsx20201231x10xk.htm)] [added: [10.2](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_102-vtrsx20201231x10xk.htm)] | | | | | | Letter Agreement entered into on February 6, 2020 by and between Pfizer Inc. and Sanjeev [removed: Narula.*] [added: Narula, filed as Exhibit 10.2 to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.*] | | |
| [10.3](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_103-vtrsx20201231x10xk.htm) | | | | | | Letter Agreement entered into on June 25, 2019 by and between Pfizer Inc. and Sanjeev [removed: Narula.*] [added: Narula, filed as Exhibit 10.3 to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.*] | | |
| [removed: [10.4](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_104-vtrsx20201231x10xk.htm)] [added: [10.4](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_104-vtrsx20201231x10xk.htm)] | | | | | | Letter Agreement entered into on June 26, 2019 by and between Pfizer Inc. and Michael [removed: Goettler.*] [added: Goettler, filed as Exhibit 10.4 to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.*] | | |
| [removed: [10.5](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_105-vtrsx20201231x10xk.htm)] [added: [10.5](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_105-vtrsx20201231x10xk.htm)] | | | | | | Letter Agreement entered into on July 29, 2019 by and between Pfizer Inc. and Michael [removed: Goettler.*] [added: Goettler, filed as Exhibit 10.5 to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.*] | | |
| [removed: [10.6](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_106-vtrsx20201231x10xk.htm)] [added: [10.6](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_106-vtrsx20201231x10xk.htm)] | | | | | | Severance Agreement entered into on December 3, 2020 by and between Viatris Inc. and Michael [removed: Goettler.*] [added: Goettler, filed as Exhibit 10.6 to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.*] | | |
| [removed: [10.7](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_107-vtrsx20201231x10xk.htm)] [added: [10.7](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_107-vtrsx20201231x10xk.htm)] | | | | | | Retention Agreement entered into on December 3, 2020, by and between Viatris Inc. and Rajiv [removed: Malik.*] [added: Malik, filed as Exhibit 10.7 to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.*] | | |
| [removed: [10.8](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_10-8xvtrsx20201231x10xk.htm)] [added: [10.8](http://www.sec.gov/Archives/edgar/data/1792044/000119312521145240/d113011dex101.htm)] | | | | | | Retention Agreement entered into on December 3, 2020, by and between Viatris Inc. and Anthony [removed: Mauro.*] [added: Mauro, filed as Exhibit 10.1 to Amendment No. 1 to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.*] | | |
| [removed: [10.9](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_109-vtrsx20201231x10xk.htm)] [added: [10.9](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_109-vtrsx20201231x10xk.htm)] | | | | | | Executive Employment Agreement, entered into on November 20, 2020, by and between Viatris Inc. and Robert J. [removed: Coury.*] [added: Coury, filed as Exhibit 10.9 to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.*] | | |
| [removed: [10.1](http://www.sec.gov/Archives/edgar/data/1623613/000119312516602386/d157810ddef14a.htm#toc157810_69)[0](http://www.sec.gov/Archives/edgar/data/1623613/000119312516602386/d157810ddef14a.htm#toc157810_69)[(a)](http://www.sec.gov/Archives/edgar/data/1623613/000119312516602386/d157810ddef14a.htm#toc157810_69)] [added: [10.10(a)](http://www.sec.gov/Archives/edgar/data/1623613/000119312516602386/d157810ddef14a.htm#toc157810_69)] | | | | | | Mylan N.V. Amended and Restated 2003 Long-Term Incentive Plan, filed as Appendix B to Mylan N.V.’s Definitive Proxy Statement on Schedule 14A filed by Mylan N.V. with the SEC on May 25, 2016, and incorporated herein by reference.* | | |
| [removed: [10.10(f)](http://www.sec.gov/Archives/edgar/data/1623613/000162361316000046/myl_ex101lx20151231-10k.htm)] [added: [10.10(g)](http://www.sec.gov/Archives/edgar/data/1623613/000162361316000046/myl_ex101lx20151231-10k.htm)] | | | | | | Form of Stock Option Agreement under the Mylan N.V. 2003 Long-Term Incentive Plan for awards granted after February 27, 2015, filed by Mylan N.V. as Exhibit 10.1(l) to Form 10-K for the fiscal year ended December 31, 2015, and incorporated herein by reference.* | | |
| [removed: [10.10(g)](http://www.sec.gov/Archives/edgar/data/1623613/000162361317000014/exhibit102_20170331.htm)] [added: [10.10(h)](http://www.sec.gov/Archives/edgar/data/1623613/000162361318000019/myl_ex102x20180331-10q.htm)] | | | | | | Form of [added: Performance-Based] Restricted Stock Unit Award Agreement under the Mylan N.V. 2003 Long-Term Incentive Plan for Rajiv Malik for awards granted on or after February [removed: 23, 2017,] [added: 21, 2018,] filed by Mylan N.V. as Exhibit 10.2 to Form 10-Q for the quarter ended March 31, [removed: 2017,] [added: 2018,] and incorporated herein by reference.* | | |
| [removed: [10.10(h)](http://www.sec.gov/Archives/edgar/data/1623613/000162361317000014/exhibit103_20170331.htm)] [added: [10.10(l)](http://www.sec.gov/Archives/edgar/data/1623613/000162361319000016/myl_ex106x20190331-10q.htm)] | | | | | | Form of Performance-Based Restricted Stock Unit Award Agreement under the Mylan N.V. 2003 Long-Term Incentive Plan for Rajiv Malik for awards granted on or after February [removed: 23, 2017,] [added: 19, 2019,] filed by Mylan N.V. as Exhibit [removed: 10.3] [added: 10.6] to Form 10-Q for the quarter ended March 31, [removed: 2017,] [added: 2019,] and incorporated herein by reference.* | | |
| [removed: [10.10(i)](http://www.sec.gov/Archives/edgar/data/1623613/000162361318000019/myl_ex102x20180331-10q.htm)] [added: [10.10(i)](http://www.sec.gov/Archives/edgar/data/1623613/000162361318000019/myl_ex103x20180331-10q.htm)] | | | | | | Form of Performance-Based Restricted Stock Unit Award Agreement under the Mylan N.V. 2003 Long-Term Incentive Plan for [removed: Rajiv Malik for] awards granted on or after February 21, 2018, filed by Mylan N.V. as Exhibit [removed: 10.2] [added: 10.3] to Form 10-Q for the quarter ended March 31, 2018, and incorporated herein by reference.* | | |
| [removed: [10.10(j)](http://www.sec.gov/Archives/edgar/data/1623613/000162361318000019/myl_ex103x20180331-10q.htm)] [added: [10.10(k)](http://www.sec.gov/Archives/edgar/data/1623613/000162361319000016/myl_ex108x20190331-10q.htm)] | | | | | | Form of [removed: Performance-Based] Restricted Stock Unit Award Agreement under the Mylan N.V. 2003 Long-Term Incentive Plan for [added: Rajiv Malik for] awards granted on or after February [removed: 21, 2018,] [added: 19, 2019,] filed by Mylan N.V. as Exhibit [removed: 10.3] [added: 10.8] to Form 10-Q for the quarter ended March 31, [removed: 2018,] [added: 2019,] and incorporated herein by reference.* | | |
| [removed: [10.10(k)](http://www.sec.gov/Archives/edgar/data/1623613/000162361319000016/myl_ex107x20190331-10xq.htm)] [added: [10.10(j)](http://www.sec.gov/Archives/edgar/data/1623613/000162361319000016/myl_ex107x20190331-10xq.htm)] | | | | | | Form of Stock Option Agreement under the Mylan N.V. 2003 Long-Term Incentive Plan for Rajiv Malik for awards granted on or after February 19, 2019, filed by Mylan N.V. as Exhibit 10.7 to Form 10-Q for the quarter ended March 31, 2019, and incorporated herein by reference.* | | |
| [removed: [10.10(l)](http://www.sec.gov/Archives/edgar/data/1623613/000162361319000016/myl_ex108x20190331-10q.htm)] [added: [10.10(m)](http://www.sec.gov/Archives/edgar/data/1623613/000162361320000018/mylex10120200331-10q.htm)] | | | | | | Form of Restricted Stock Unit Award Agreement under the Mylan N.V. 2003 Long-Term Incentive Plan for [removed: Rajiv Malik] [added: independent directors] for awards granted on or after [removed: February 19, 2019,] [added: March 2, 2020,] filed by Mylan N.V. as Exhibit [removed: 10.8] [added: 10.1] to Form 10-Q for the quarter ended March 31, [removed: 2019,] [added: 2020,] and incorporated herein by reference.* | | |
| [removed: [10.10(m)](http://www.sec.gov/Archives/edgar/data/1623613/000162361319000016/myl_ex106x20190331-10q.htm)] [added: [10.10(n)](http://www.sec.gov/Archives/edgar/data/1623613/000162361320000018/mylex10220200331-10q.htm)] | | | | | | Form of [removed: Performance-Based Restricted] Stock [removed: Unit Award] [added: Option] Agreement under the Mylan N.V. 2003 Long-Term Incentive Plan for [removed: Rajiv Malik] [added: independent directors] for awards granted on or after [removed: February 19, 2019,] [added: March 2, 2020,] filed by Mylan N.V. as Exhibit [removed: 10.6] [added: 10.2] to Form 10-Q for the quarter ended March 31, [removed: 2019,] [added: 2020,] and incorporated herein by reference.* | | |
| [removed: [10.10(n)](http://www.sec.gov/Archives/edgar/data/1623613/000162361320000018/mylex10120200331-10q.htm)] [added: [10.1(f)](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000018/ex_101xvtrsx20210331x10-q.htm)] | | | | | | Form of Restricted Stock Unit Award Agreement under the [removed: Mylan N.V. 2003 Long-Term] [added: Viatris Inc. 2020 Stock] Incentive Plan for [removed: independent directors for] awards granted on or after March 2, [removed: 2020, filed by Mylan N.V.] [added: 2021, included] as Exhibit 10.1 to Form 10-Q for the quarter ended March 31, [removed: 2020,] [added: 2021] and incorporated [removed: herein] by [removed: reference.*] [added: reference herein.*] | | |
| [removed: [10.10(o)](http://www.sec.gov/Archives/edgar/data/1623613/000162361320000018/mylex10220200331-10q.htm)] [added: [10.1(g)](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000018/ex_102xvtrsx20210331x10-q.htm)] | | | | | | Form of [added: Performance-Based Restricted] Stock [removed: Option] [added: Unit Award] Agreement under the [removed: Mylan N.V. 2003 Long-Term] [added: Viatris Inc. 2020 Stock] Incentive Plan for [removed: Independent directors for] awards granted on or after March 2, [removed: 2020, filed by Mylan N.V.] [added: 2021, included] as Exhibit 10.2 to Form 10-Q for the quarter ended March 31, [removed: 2020,] [added: 2021] and incorporated [removed: herein] by [removed: reference.*] [added: reference herein.*] | | |
| [10.24](http://www.sec.gov/Archives/edgar/data/1623613/000162361320000011/mylex102920191231-10k.htm) | | | | | | 2007 Supplemental Health Insurance Plan for Certain Key Employees of Mylan Laboratories Inc., adopted as of January 29, 2007, filed by Mylan N.V. as Exhibit [removed: 10.19] [added: 10.29] to the Form 10-K for the fiscal year ended December 31, 2019 and incorporated herein by reference.* | | |
| [removed: [10.25](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_1025-vtrsx20201231x10xk.htm)] [added: [10.25](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_1025-vtrsx20201231x10xk.htm)] | | | | | | Form of Indemnification Agreement between Viatris Inc. and each of its directors and its executive [removed: officers.*] [added: officers, filed as Exhibit 10.25 to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.*] | | |
| [removed: [10.28](http://www.sec.gov/Archives/edgar/data/1792044/000119312520170586/d133688dex101.htm)] [added: [10.28(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520170586/d133688dex101.htm)] | | | | | | Revolving Credit Agreement, dated as of June 16, 2020, among Upjohn Inc., the guarantors from time to time party thereto, the lenders and issuing banks from time to time party thereto and Bank of America, N.A., as administrative agent, filed as Exhibit 10.1 to the Report on Form 8-K filed by Upjohn Inc. with the SEC on June 17, 2020, and incorporated herein by reference. | | |
| [removed: [10.30](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex101.htm)] [added: [10.31](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex101.htm)] | | | | | | Form of Dealer Agreement among Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V., Mylan Inc. and the dealer thereto, filed as Exhibit 10.1 to the Report on Form 8-K/A filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. | | |
| [removed: [10.31](http://www.sec.gov/Archives/edgar/data/1623613/000119312517263762/d418144dex101.htm)] [added: [10.32](http://www.sec.gov/Archives/edgar/data/1623613/000119312517263762/d418144dex101.htm)] | | | | | | Settlement Agreement with the U.S. Department of Justice and two relators finalizing the Medicaid drug rebate settlement, dated August 16, 2017, filed as Exhibit 10.1 to the Report on Form 8-K filed by Mylan N.V. with the SEC on August 21, 2017, and incorporated herein by reference. | | |
| [removed: [10.32](http://www.sec.gov/Archives/edgar/data/1623613/000119312517263762/d418144dex102.htm)] [added: [10.33](http://www.sec.gov/Archives/edgar/data/1623613/000119312517263762/d418144dex102.htm)] | | | | | | Corporate Integrity Agreement between the Office of Inspector General of the Department of Health and Human Services and Mylan Inc. and Mylan Specialty L.P., dated August 16, 2017, filed as Exhibit 10.2 to the Report on Form 8-K filed by Mylan N.V. with the SEC on August 21, 2017, and incorporated herein by reference. | | |
| [removed: [10.33](http://www.sec.gov/Archives/edgar/data/1792044/000119312520181088/d920857dex48.htm)] [added: [10.34](http://www.sec.gov/Archives/edgar/data/1792044/000119312520181088/d920857dex48.htm)] | | | | | | Registration Rights Agreement, dated as of June 22, 2020, by and between Upjohn Inc. and Goldman Sachs & Co. LLC, BofA Securities, Inc., Citigroup Global Markets Inc., Morgan Stanley and Co. LLC, and Mizuho Securities USA LLC, as representatives of the several initial purchasers of the U.S. Dollar Notes, filed as Exhibit 4.8 to the Report on Form 8-K filed by Upjohn Inc. with the SEC on June 26, 2020, and incorporated herein by reference. | | |
| [removed: [10.34(a)](http://www.sec.gov/Archives/edgar/data/1623613/000162361320000035/ex102myl10-q09302020.htm)] [added: [10.35(a)](http://www.sec.gov/Archives/edgar/data/1623613/000162361320000035/ex102myl10-q09302020.htm)] | | | | | | Asset Purchase Agreement, dated as of September 7, 2020, between Aspen Global Incorporated and Mylan Ireland Limited, filed by Mylan N.V. as Exhibit 10.2 to the Form 10-Q for the quarter ended September 30, 2020, and incorporated herein by reference.^ | | |
| [removed: [10.34(b)](https://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_1034b-vtrsx20201231x10xk.htm)] [added: [10.35(b)](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_1034b-vtrsx20201231x10xk.htm)] | | | | | | Amendment No. 1, dated as of November 5, 2020, to the Asset Purchase Agreement dated as of September 7, 2020, between Aspen Global Incorporated and Mylan Ireland [removed: Limited.^] [added: Limited, filed as Exhibit 10.34(b) to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference. ^] | | |
| [removed: [10.35](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex101.htm)] [added: [10.36](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex101.htm)] | | | | | | Transition Services Agreement, dated as of November 16, 2020, by and between Pfizer Inc. (as Service Provider) and Upjohn Inc. (as Service Recipient), filed as Exhibit 10.1 to the Report on Form 8-K filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. ^ | | |
| Year ended December 31, 2021 | | | $ | 159.9 | | | | | 16.0 | | | | | | — | | | | | | (21.4) | | | | | | $ | 154.5 | |
| Year ended December 31, 2021 | | | $ | 443.6 | | | | | 82.2 | | | | | | 260.8 | | | | | | (6.2) | | | | | | $ | 780.4 | |
| [2.2(b)](http://www.sec.gov/Archives/edgar/data/0001623613/000162361320000018/mylex2120200331-10q.htm) | | | | | | Amendment No. 1, dated as of February 18, 2020, to the Separation and Distribution Agreement, dated as of July 29, 2019, by and between Pfizer Inc. and Upjohn Inc., filed by Mylan N.V. as Exhibit 2.1 to the Form 10-Q for the quarter ended March 31, 2020, and incorporated herein by reference. | | |
| [10.1(h)](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000018/ex_103xvtrsx20210331x10-q.htm) | | | | | | Form of Director Restricted Stock Unit Award Agreement under the Viatris Inc. 2020 Stock Incentive Plan for non-employee directors for awards granted on or after March 2, 2021, included as Exhibit 10.3 to Form 10-Q for the quarter ended March 31, 2021 and incorporated by reference herein.* | | |
| [10.28(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312521206477/d50384dex101.htm) | | | | | | Amended and Restated Revolving Credit Agreement, dated as of July 1, 2021, among Viatris, the guarantors from time to time party thereto, the lenders and issuing banks from time to time party thereto and Bank of America, N.A., as administrative agent, filed as Exhibit 10.1 to the Report on Form 8-K filed by Viatris Inc. with the SEC on July 1, 2021, and incorporated herein by reference. ^ | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | | | |
| Year ended December 31, 2018 | | | $ | 75.3 | | | | | 32.3 | | | | | | 0.2 | | | | | | (9.6) | | | | | | $ | 98.2 | |
| Year ended December 31, 2018 | | | $ | 662.8 | | | | | 203.8 | | | | | | — | | | | | | (60.6) | | | | | | $ | 806.0 | |
An excerpt. Shown here: 40 of 55 rewritten, all 7 added and all 2 removed. The counts are complete. For every sentence, read Item 15. Exhibits, Consolidated Financial Statement Schedules in the FY2021 filing and the FY2020 filing.