Viatris (VTRS) 10-K risk factor changes: FY2022 vs FY2021
The 2022-12-31 10-K against the 2021-12-31 one, compared heading by heading and sentence by sentence.
Item 1A161 rewritten63 added138 removed519 unchanged
All filing items1,249 rewritten651 added648 removed2,694 unchanged
Summary
counted, not written
- Item 1A lists 43 risk factor headings: 5 new, 6 reworded and 32 unchanged since FY2021. 9 headings from FY2021 no longer appear.
- Sentence by sentence, 651 added, 648 removed, 1,249 rewritten and 2,694 unchanged across 11 items that differ.
New Item 1A headings (5)
- We may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, our strategic initiatives, including divestitures, acquisitions or other potential transactions.
- The integration of acquired businesses, as well as our global restructuring program, have presented and may in the future present significant challenges.
- Viatris may be subject to significant U.S. tax liabilities or be obligated to indemnify Pfizer for any such tax liability imposed on Pfizer in connection with the Combination.
- Viatris has suffered and in the future could suffer additional losses due to impairment charges.
- Viatris has certain material obligations relating to defined benefit pension and termination benefit programs.
Removed Item 1A headings (9)
- The integration of the Upjohn Business with Mylan following the Combination, as well as our global restructuring program, may present significant challenges.
- Viatris may not realize the anticipated benefits from the Combination or its global restructuring program.
- Viatris could incur operational difficulties or losses if 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, or if we are required to make payments to Pfizer pursuant to indemnities agreed to as part of the Combination.
- Viatris may be subject to significant U.S. tax liabilities, or be obligated to indemnify Pfizer for any such tax liability imposed on Pfizer and is subject to potentially significant restrictions that could limit its ability to undertake certain corporate actions (such as stock issuances or the undertaking of a merger or consolidation).
- Our strategic initiatives, including our strategic alliances, may not achieve all intended benefits.
- 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.
- If we fail to comply with our corporate integrity agreement, we could be subject to substantial penalties and exclusion from participation in federal healthcare programs.
- Viatris could suffer additional losses due to asset impairment charges.
- In connection with the Combination, Viatris assumed or retained certain material obligations relating to defined benefit pension and termination benefits and retiree medical and dental benefits associated with legacy employees of the Upjohn Business and/or sponsored by Upjohn entities. These liabilities and the related future funding obligations could restrict cash available for Viatris’ operations, capital expenditures, dividend payments and other requirements, and may materially adversely affect Viatris’ financial condition and liquidity.
Reworded Item 1A headings (6)
- There are risks and uncertainties associated with the
[removed: pending transaction involving][added: sale of] 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. - Current and changing economic
[removed: conditions][added: conditions, including inflation,] may adversely affect our industry, business, partners and suppliers. - Increasing scrutiny and evolving expectations from customers, regulators, [added: governments,] investors, [added: lenders,] 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.
- There can be no guarantee that we will continue to pay dividends or
[removed: that we will implement repurchases][added: repurchase shares] under our stock buyback program. - Currency fluctuations and changes in exchange rates [added: have impacted and] could [added: continue to] adversely affect our business, financial condition, results of operations, cash flows, ability to pay dividends and/or stock price.
- The market price of our common stock [added: has been and] may [added: continue to] be volatile, and the value of your investment could materially decline.
A heading is new when no FY2021 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
| Item | Added | Removed | Rewritten | Unchanged |
|---|---|---|---|---|
| Item 1A. Risk Factors | 63 | 138 | 161 | 519 |
| Item 7. Management’s Discussion and Analysis of Financial Condition And Results of Operations | 128 | 93 | 207 | 358 |
| Item 7A. Quantitative and Qualitative Disclosures About Market Risk | 5 | 0 | 3 | 22 |
| Item 1. Business | 93 | 32 | 70 | 246 |
| Item 3. Legal Proceedings | 0 | 0 | 1 | 0 |
| Cover and table of contents | 12 | 19 | 38 | 206 |
| Item 1B. Unresolved Staff Comments | 0 | 0 | 0 | 1 |
| Item 2. Properties | 0 | 0 | 0 | 1 |
| Item 4. Mine Safety Disclosures | 0 | 0 | 0 | 2 |
| Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 4 | 11 | 8 | 10 |
| Item 6. [Reserved] | 0 | 0 | 0 | 0 |
| Item 8. Financial Statements And Supplementary Data | 337 | 339 | 703 | 1,156 |
| Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures | 0 | 0 | 0 | 1 |
| Item 9A. Controls and Procedures | 1 | 0 | 6 | 1 |
| Item 9B. Other Information | 0 | 0 | 0 | 1 |
| Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 0 | 0 | 0 | 2 |
| Item 10. Directors, Executive Officers and Corporate Governance | 0 | 0 | 0 | 5 |
| Item 11. Executive Compensation | 0 | 0 | 0 | 1 |
| Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 2 | 2 | 1 | 7 |
| Item 13. Certain Relationships and Related Transactions, and Director Independence | 0 | 0 | 0 | 1 |
| Item 14. Principal Accounting Fees and Services | 0 | 0 | 0 | 2 |
| Item 15. Exhibits, Consolidated Financial Statement Schedules | 6 | 14 | 51 | 152 |
Underlined words on a shaded ground are new in FY2022; struck-through words were in FY2021. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. Risk Factors
161 rewritten, 63 added, 138 removed, 519 unchanged
Our risk factors are organized into [removed: six] [added: five] categories: [removed: Combination,] Strategic, Operational, Compliance, Finance and General.
◦The integration of [removed: the Upjohn Business with Mylan following the Combination,] [added: acquired businesses,] as well as our global restructuring [removed: program,] [added: program have presented and] may [added: in the future] present significant challenges.
[removed: ◦Public] [added: Public] health outbreaks, epidemics and pandemics, including the COVID-19 pandemic, have had and could continue to have a material adverse effect on our business, [removed: financial condition, results of operations, cash flows and/or stock price and may impact] [added: including] our [removed: ability to pay dividends.][added: workforce, suppliers, vendors, business partners, distribution channels, customers and patients.]
◦Current and changing economic [removed: conditions] [added: conditions, including inflation,] may adversely affect our industry, business, partners and suppliers.
◦There can be no guarantee that we will continue to pay dividends or [removed: that we will implement a] [added: repurchase shares under our] stock buyback program.
◦We may not be able to maintain competitive financial flexibility and our corporate tax rate which could adversely affect us and our [removed: shareholders][added: shareholders.]
[removed: ◦We] [added: We] have significant indebtedness, which could lead to adverse consequences or adversely affect our financial position and prevent us from fulfilling our obligations under such indebtedness, and any refinancing of this debt could be at significantly higher interest rates.
◦Viatris [added: has suffered and in the future] could suffer additional losses due to [removed: asset] impairment charges.
The integration of [removed: the Upjohn Business with Mylan following the Combination,] [added: acquired businesses,] as well as our global restructuring program, [added: have presented and] may [added: in the future] present significant challenges.
The combination of two [added: or more] independent [removed: businesses] [added: businesses, including, for example, the Combination and our recent acquisitions of Oyster Point and Famy Life Sciences,] is a complex, costly and time-consuming process and there is a significant degree of difficulty inherent in the [removed: process of integrating the Upjohn Business and Mylan.][added: integration process.]
These difficulties [added: may] include:
- the challenge of integrating the employees and business [removed: cultures of the Upjohn Business and Mylan;][added: cultures;]
- the challenge and cost of integrating manufacturing, logistics, information technology, communications and other [removed: systems of the Upjohn Business and Mylan;][added: systems;]
- the potential difficulty retaining key personnel and other [removed: employees of Mylan and the Upjohn Business;][added: employees;]
- challenges in reducing reliance on [removed: certain] transition [removed: services provided by Pfizer,] [added: services,] including [removed: difficulty] [added: difficulties in] hiring employees or finding [removed: other] suitable [removed: replacements and managing the amounts of related replacement costs,] [added: replacements,] prior to the expiration of any period in which such services are provided; and
- reducing costs associated with [removed: the] transition [removed: services provided by Pfizer.][added: services, including managing the amount for replacement costs.]
[removed: In addition to integration activities with respect to Mylan and the Upjohn Business,] Viatris [removed: is] [added: has] also [removed: implementing] [added: undertaken] a significant global restructuring program in order to achieve specified synergies and ensure the [removed: new company] [added: Company] is optimally structured and efficiently resourced to deliver sustainable value to patients, shareholders, customers, and other stakeholders.
If [removed: our senior management is not able to timely and effectively manage these] integration [added: activities] or [added: our global] restructuring [removed: processes, significant business activities] [added: program] are [removed: interrupted, or there is a delay] [added: unsuccessful, if the estimated costs are higher than anticipated,] or [removed: inability] [added: if we are unable] to [removed: achieve] [added: realize the] anticipated [removed: integration or restructuring goals, Viatris may not be able to achieve its synergy targets] [added: synergies] and [added: other benefits,] there could be a material adverse effect on Viatris’ business, financial condition, results of operations, cash flows, ability to pay dividends and/or stock price.
Even if the integration and global restructuring program are successful, we may not achieve [removed: these] [added: anticipated] synergies, growth opportunities and other financial and operating benefits within the timeline we anticipate, or at all.
[removed: The] [added: Any] quantification of synergies expected to result from [removed: the Combination] [added: a transaction or restructuring activities] is based on significant estimates and assumptions that are subjective in nature and inherently uncertain.
Realization of any benefits and synergies [added: from acquired businesses or our global restructuring program] could be affected by a number of factors beyond our control, including, without limitation, general economic conditions, increased operating costs, regulatory developments, and the other risks described in these risk factors.
The amount of synergies actually [removed: realized as a result of the Combination,] [added: realized,] if any, and the time periods in which any such synergies are realized, could differ materially from our current expectations and [removed: estimates, regardless of whether the two business operations are combined successfully.][added: estimates.]
In addition, if key personnel and other employees depart because of issues relating to the uncertainty and difficulty of integration [added: or restructuring] activities, [removed: Viatris’ ability to] [added: Viatris may not] realize the anticipated benefits of [removed: the Combination could be reduced.][added: these activities.]
[removed: If the integration] [added: that reduce our revenues] or [added: increase] our [removed: global restructuring program are unsuccessful, if the estimated] costs [removed: are higher than anticipated, or if we are unable to realize the anticipated synergies and other benefits of the Combination, there] could [removed: be] [added: have] a material adverse effect on [removed: Viatris’] [added: our] business, financial condition, results of operations, cash flows, ability to pay dividends and/or stock price.
Any [removed: payments pursuant to these indemnities could be significant and] [added: of the risks described above] could have a material adverse effect on our [added: reputation,] business, financial condition, results of operations, cash flows, ability to pay dividends [removed: or] [added: and/or] stock price.
Viatris may be subject to significant U.S. tax [removed: liabilities,] [added: liabilities] or be obligated to indemnify Pfizer for any such tax liability imposed on Pfizer [removed: and is subject to potentially significant restrictions that could limit its ability to undertake certain corporate actions (such as stock issuances or] [added: in connection with] the [removed: undertaking of a merger or consolidation).][added: Combination.]
In connection with the Combination, Pfizer received [removed: the IRS Ruling] [added: a private letter ruling] and [removed: the Tax Opinion,] [added: opinion of counsel,] each to the effect that, for U.S. federal income tax purposes, the Distribution, together with certain related transactions, [removed: will] [added: would] qualify as a tax-free “reorganization” [removed: within the meaning of Section 368(a)(1)(D) of the Code,] [added: and] the Distribution [removed: will] [added: would] qualify as a tax-free [removed: distribution 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.][added: distribution.]
If the Distribution were determined not to have qualified for tax-free [removed: treatment under Section 355 of the Code,] [added: treatment,] Pfizer would generally be subject to tax as if it sold the Viatris common stock in a transaction taxable to Pfizer, which could result in a material tax liability that, under certain circumstances, Viatris may be required to indemnify Pfizer against pursuant to the Tax Matters Agreement.
[removed: There] [added: ◦There] are risks and uncertainties associated with the [removed: pending transaction involving] [added: sale of] our biosimilars business, one or more of [removed: which could] [added: which could] have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or stock [removed: price.][added: price.]
We have [added: also] 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.
In [removed: addition, in] connection with the closing of the [removed: pending] transaction with Biocon Biologics, we [removed: will enter] [added: entered] into a transition services agreement pursuant to which we will provide services to Biocon Biologics, including commercialization services substantially [removed: the same as we currently provide to our biosimilar business, generally for a period of up to two years.]
[removed: Once in effect, our] [added: Our] obligations under the transition services agreement may result in additional expenses that are borne by us [added: during] and [added: after the exit from the transition services agreement,] may [added: create stranded costs, or 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 [removed: will receive] [added: received] in the [removed: pending transaction with] Biocon [removed: will be] [added: Biologics Transaction is] in the form of equity in Biocon Biologics, which is [added: currently] a privately held Indian company.
In addition, we believe the success of the Biocon [removed: biologics] [added: Biologics] business [removed: over at least the first two years after closing,] will be highly dependent upon the successful transition of the business to [removed: Biocon,] [added: Biocon Biologics,] including no major disruption in services provided under the transition services [removed: agreement, which will also have a significant impact on the value of the equity we will own in Biocon Biologics.][added: agreement.]
We may also [removed: 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 [added: realizing the anticipated proceeds,] 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.
[removed: Any of the risks described above] [added: These events] could have a material adverse effect on [added: the way we operate] our business, [added: including the resiliency of our supply chain, our] financial condition, results of operations, cash flows, ability to pay dividends and/or stock price.
These transactions and arrangements [added: have been and] may [added: in the future] be material both from a strategic and financial perspective.
We may miscalculate the risks associated with our strategic [removed: initiatives, including business development transactions,] [added: initiatives] 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.
[removed: Furthermore, divestitures,] [added: Divestitures,] product rationalizations or asset sales [added: have resulted and] could [added: continue to] result in [added: asset impairments or] decreased [removed: total revenues, results of operations] [added: revenues] and cash [removed: flows from operating activities in future periods,] [added: flows, or] 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, [removed: should] we [removed: seek] [added: may not be able] to [removed: divest other of our assets and business, we] [added: obtain the required regulatory approvals for a planned divestiture, or] may be unable to dispose of [removed: such] businesses [removed: and assets] [added: that we intend to divest] 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.
◦We may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, our strategic initiatives, including divestitures, acquisitions or other potential transactions.
We may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, our strategic initiatives, including divestitures, acquisitions or other potential transactions.
Viatris has announced various strategic initiatives, transactions and business arrangements, including our two-phased strategic vision.
In Phase 1 of this strategy, we have been focused on reducing debt, maintaining an investment grade credit rating and returning capital to shareholders.
In preparation for the second phase, the Company has completed certain transactions, including the Biocon Biologics Transaction, and has announced plans for certain other strategic actions, such as its intent to divest certain businesses no longer considered to be core to its future strategy, including OTC, women’s health care (primarily related to our oral and injectable contraceptives), API (while retaining some selective API capabilities) and Upjohn Distributor Markets.
The Company anticipates a period of renewed growth and leadership in this second phase as it intends to move up the value chain by focusing on more complex and innovative products to build a more durable higher margin portfolio.
Implementing these and other strategic initiatives has included and may in the future include divestitures, acquisitions, asset purchases, partnerships, collaborations, joint ventures, product rationalization and other investments.
These initiatives, whether we are able to complete them or not, have been and may continue to be complex, time-consuming or expensive, may divert managements’ attention, and expose us to operational ineffectiveness.
More complex products are more difficult, costly and time-consuming to develop, receive regulatory approval for and bring to market.
There can be no assurance that we will be able to achieve all of our intended goals or outlooks with respect to such strategies within the anticipated timeframes or at all, fully realize the expected benefits of any such transactions or arrangements, or successfully manage base business erosion or grow in future periods.
We may not be successful in separating underperforming or non-core assets, which could negatively impact our ongoing operations, future earnings and future goals and outlooks.
Certain divestitures also have resulted and may in the future result in continued financial exposure to the divested assets or businesses, such as through guarantees, or other financial arrangements, continued supply and services arrangements, continued provision of corporate functions to the divested business, stranded costs, or potential litigation.
and collaborative arrangements will not generate financial returns.
- loss of institutional knowledge;
the same as we historically provided to our biosimilar business.
If Biocon Biologics is not prepared to operate the business independently at the end of the negotiated transition period, we may need to provide transition services for a longer than anticipated period of time, which would increase these risks.
If this transition is not successful, it would have a significant impact on the value of the equity we will own in Biocon Biologics and could negatively impact our business or financial condition.
Because our former biosimilars business was commingled with Viatris’ other businesses, the financial information for the biosimilars business is being carved-out of Viatris’ financial and other systems, and will impact the reporting of our results of operations, financial condition, and cash flows.
This process increases the risk of errors in the presentation of our financial results in conformity with U.S. GAAP.
In addition, rising rates of inflation have increase and may continue to increase pressure on governments, insurers and other payors to implement additional cost containment measures.
drugs to pass a test to assess their bioequivalence to a qualified reference drug (typically the originator drug).In addition, since 2018, China's National Healthcare Security Administration, in conjunction with relevant departments, has been promoting a centralized VBP policy for drugs, which has become standard practice and subjects many drugs to a competitive bidding process.
Some states have also signed into law programs that compel manufacturers to provide certain medicines at free or reduced costs to certain patients, and additional states are exploring such programs.
In 2022, President Biden signed into law the Inflation Reduction Act, which includes numerous Medicare reforms that will affect reimbursement for certain pharmaceuticals covered by Medicare and modify the Part D and Part B program structure, including shifting the liability for certain prescription drug costs shared between Medicare, pharmaceutical manufacturers, and Part D plans.
These reforms include government price negotiation for certain high-spend, single-source Medicare drugs, out-of-pocket caps for Medicare beneficiaries using insulin products, and the application of inflation-based rebates for certain Medicare drugs.
Significant additional reforms to the U.S. healthcare system, including changes to the ACA, Medicare and Medicaid, or changes to other laws or regulatory frameworks in other markets in which we operate,
In addition, a significant escalation or expansion of the conflict’s current scope may have a negative impact on our operations and financial results in future periods;
- inflation or hyperinflation in certain markets, including Turkey;
In addition, several companies have filed ANDAs seeking regulatory approval in the United States to market a generic version of our Yupelri product prior to the expiration of certain patents.
For example, if the U.S. government defaults on its debt, or the U.S. Treasury takes measures to avoid such a default, or if there is an assumption that such an event may occur, this could have a negative impact on general economic conditions, including the liquidity of and access to the capital markets.
In particular, during 2022, the global economy has been impacted by high levels of inflation and rising energy costs, which has resulted in significant economic volatility.
As a result, central banks have and continue to tighten their monetary policies and increase interest rates.
These macroeconomic pressures combined with the volatility in foreign exchange rates, including the strengthening of the U.S. dollar versus the other currencies in which we operate, negatively impacted our results of operations.
While inflationary and other macroeconomic pressures may ease, we continue to experience higher costs and we expect that this will likely continue throughout 2023, thereby negatively impacting our results of operations.
These requirements include regulation of the handling,
For example, in order to comply with foreign ownership restrictions and meet regulatory licensing, and cybersecurity requirements, we conduct some of our business in China through variable interest entities.
Although we believe these structures and activities related to our VIEs comply with existing laws and regulations in China, they involve unique risks and uncertainties, including that China may from time to time consider and implement additional changes in their legislative, regulatory, licensing, or other requirements that could subject us to penalties and impact these structures and activities.
A regulatory approval
In
In addition, as a result of changes in the provision of healthcare, we have experienced, and could continue to experience, unpredictable fluctuations in demand for certain of our products.
For the years ended December 31, 2022 and 2021, Viatris’ top three customers in terms of net sales, in the aggregate, represented approximately 26% and 23%, respectively, of the Company’s consolidated total net sales.
- Combination Risks
◦Viatris may not realize the anticipated benefits from the Combination or its global restructuring program.
◦Viatris could incur operational difficulties or losses if 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, or if we are required to make payments to Pfizer pursuant to indemnities agreed to as part of the Combination.
◦The risks and uncertainties associated with the pending transaction involving our biosimilars business.
◦Our strategic initiatives, including our strategic alliances, may not achieve all intended benefits.
◦If we fail to comply with our corporate integrity agreement, we could be subject to substantial penalties and exclusion from participation in federal healthcare programs.
Combination Risks
There is no assurance that Viatris will be able to manage this integration or restructuring in the manner or on the timelines currently anticipated.
Viatris may not realize the anticipated benefits from the Combination or its global restructuring program.
Viatris is expected to realize synergies, growth opportunities, and other financial and operating benefits as a result of the Combination.
Viatris’ success in realizing these benefits, and the timing of their realization, depends on the successful integration of the Upjohn Business with Mylan, as well as the success of our global restructuring program.
See “*The integration of the Upjohn Business with Mylan following the Combination, as well as our global restructuring program, may present significant challenges*” above.
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.
Viatris could incur operational difficulties or losses if 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, or if we are required to make payments to Pfizer pursuant to indemnities agreed to as part of the Combination.
In connection with the Combination, Viatris entered into several agreements with Pfizer or its subsidiaries, including among others, transition services and the manufacturing and supply agreements, which in general provide for the performance of certain services or obligations by each of Pfizer and Viatris for the benefit of each other for a transitional period following the Combination.
If either party is unable to satisfy its obligations under such agreements in a timely manner or at all, or if the transitional agreements fail to provide for or cover certain essential services needed by Viatris during the applicable transitional period, we have limited recourse and could incur operational difficulties or losses or face liability.
In particular, the legacy Upjohn Business historically received benefits and services from Pfizer.
Viatris no longer benefits from Pfizer’s services or business relationships to the extent not otherwise addressed in the definitive documents entered into in connection with the Combination.
While Pfizer has agreed to provide certain transition services to Viatris for a transitional period following the Combination, such services may not provide benefits equivalent to the services provided when the Upjohn Business was operating as a part of Pfizer.
Viatris may not be able to adequately replace resources formerly provided by Pfizer, or replace such services at the same or lower cost.
Viatris may also need to make significant investments to replicate or outsource from other providers certain facilities, systems, infrastructure, and personnel to which it no longer has access and may incur significant costs to replace such services.
In addition, we may experience operational disruptions associated with ending the transition services that Pfizer has agreed to provide Viatris under the transition agreements as Viatris transitions off of and attempts to replace these services.
Further, because Viatris is reliant on Pfizer for such services during the transitional period, any interruption, disruption or breach of Pfizer’s systems relating to such services, including information technology and information security systems, could have a material adverse effect on our business, financial condition and results of operations.
In connection with such transition services, Viatris and Pfizer agreed, among other things, that each of them will each bear 50% of the first $380 million of certain reasonable out-of-pocket costs incurred by Pfizer in connection with the services, with Viatris bearing all of such costs in excess of $380 million.
As of December 31, 2021, the Company has incurred approximately $83.5 million of such expenses.
In addition, in connection with the Combination, Viatris agreed to indemnify Pfizer for certain liabilities.
See “*We are involved in various legal proceedings and certain government inquiries and may experience unfavorable outcomes of such proceedings or inquiries*” below.
Although the IRS Ruling is generally binding on the IRS, the continuing validity of the IRS Ruling is subject to the accuracy of the factual representations made in the ruling request.
An opinion of tax counsel neither binds the IRS nor precludes the IRS or the courts from adopting a contrary position.
Accordingly, notwithstanding the IRS Ruling and Tax Opinion, there can be no assurance that the IRS will not assert a position contrary to one or more of the conclusions set forth herein and if the IRS prevails in such challenge, the U.S. federal income tax consequences of the Distribution, together with certain related transactions, to Pfizer, Viatris and the holders of Pfizer common stock could be materially different from, and worse than, the U.S. federal income tax consequences described below.
Even if the Distribution were otherwise to qualify as a tax-free transaction under Sections 368(a)(1)(D) and 355 of the Code, the Distribution would be taxable to Pfizer (but not to Pfizer’s stockholders) pursuant to Section 355(e) of the Internal Revenue Code if there were a 50 percent or greater change in ownership of either Pfizer or Viatris, directly or indirectly, as part of a plan or series of related transactions that included the Distribution.
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 (i.e., on November 16, 2022) are presumed to be part of such a plan, although Pfizer may be able to rebut that presumption.
For purposes of this test, the Combination will be treated as part of a plan, but the Combination standing alone will not cause the Distribution to be taxable to Pfizer under Section 355(e) of the Code because holders immediately before the Distribution of Pfizer common stock directly owned more than 50 percent of Viatris common stock immediately following the Combination.
Nevertheless, if the IRS were to determine that other acquisitions of Pfizer common stock or Viatris common stock, either before or after the Distribution, were part of a plan or series of related transactions that included the Distribution, such determination could result in the recognition of a material amount of taxable gain for U.S. federal income tax purposes by Pfizer under Section 355(e) of the Code.
Under the Tax Matters Agreement, Viatris will be required to indemnify Pfizer against any taxes resulting from the Distribution or certain aspects of the Separation that arise as a result of Viatris’ breach of certain representations or covenants in the Tax Matters Agreement or certain other acts or omissions by Viatris, including certain actions that could result in Section 355(e) of the Code applying to the Distribution.
In addition, the Tax Matters Agreement generally prohibits Viatris and its affiliates from taking certain actions that could cause the Distribution and certain related transactions to fail to qualify as tax-free transactions to Pfizer and its stockholders.
Furthermore, unless an exception applies, for a two-year period following the date of the Distribution (i.e., until November 16, 2022), Viatris and its subsidiaries may not:
- engage in transactions in which Viatris’ stock is acquired;
- engage in certain mergers or consolidations;
- discontinue the active conduct of the Upjohn Business;
An excerpt. Shown here: 40 of 161 rewritten, 40 of 63 added and 40 of 138 removed. The counts are complete. For every sentence, read Item 1A. Risk Factors in the FY2022 filing and the FY2021 filing.
Item 7. Management’s Discussion and Analysis of Financial Condition And Results of Operations
207 rewritten, 128 added, 93 removed, 358 unchanged
Such forward-looking statements may include, without limitation, statements about the [removed: Biocon Biologics Transaction; statements about] [added: goals or outlooks with respect to] the [removed: Combination,] [added: Company’s strategic initiatives, including but not limited to] the [added: Company’s two-phased strategic vision and potential divestitures and acquisitions; the] benefits and synergies of [removed: the Combination] [added: acquisitions, divestitures] 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 policy and payments, [added: stock repurchases,] debt ratio and covenants, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competitions, 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.
- the possibility that the Company may be unable to achieve expected benefits, synergies and operating efficiencies in connection with [removed: the Combination] [added: acquisitions, divestitures,] or its global restructuring [removed: program] [added: program,] within the expected timeframe or at all;
- the possibility that the Company may be unable to [removed: achieve all] [added: realize the] intended benefits [removed: of] [added: of, or achieve the intended goals or outlooks with respect to,] its strategic initiatives;
- changes in relevant laws and regulations, including but not limited to changes in tax, healthcare and pharmaceutical laws and regulations globally (including the impact of [added: recent and] potential tax reform in the U.S.);
- the effect of any changes in the Company’s or its partners’ customer and supplier relationships and customer purchasing patterns, including customer loss and business disruption being greater than expected following [removed: the Combination;][added: an acquisition or divestiture;]
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 [added: key] stakeholders.
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 [added: an] 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, generics, [added: and] complex generics, [removed: and biosimilars.][added: including biosimilars prior to the Biocon Biologics Transaction.]
The Company reports segment information on the basis of markets and geography, which reflects its focus on bringing its broad and diversified portfolio of branded, complex [removed: generics and biosimilars,] [added: generics, including biosimilars prior to the Biocon Biologics Transaction,] and generic products to people in markets everywhere.
*Biocon Biologics [removed: Agreement*][added: Transaction*]
On February [removed: 28,] [added: 27,] 2022, [removed: the Company] [added: Viatris] entered into [removed: an] [added: a definitive] agreement [added: with Biocon Biologics] to contribute its biosimilars [removed: business] [added: portfolio] to Biocon Biologics.
The [removed: Company has not yet repurchased any shares of common stock under the] share repurchase program [removed: and the share repurchase program] does not obligate the Company to acquire any particular amount of common stock.
The Company’s priorities remain protecting the health and safety of our workforce, continuing to produce critically needed medicines, deploying resources and expertise in the fight against COVID-19 [removed: through potential prevention and treatment efforts, supporting the communities in which we operate and maintaining the health of our overall business.]
As a result, [removed: many Viatris administrative offices continue operating under work from home protocols and] some of our customer facing field personnel continue on a remote engagement model to ensure continued support for healthcare professionals, patient care and access to needed [removed: products.][added: products and we have continued to take extra precautions at our manufacturing facilities to protect our site personnel and operations.]
[removed: Additionally, all] [added: 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 disruptions.
The global spread of COVID-19 has created and continues to create [removed: significant] volatility, uncertainty and economic disruption affecting the markets we serve, including impacts on 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 predict, and could adversely impact our [added: financial condition and] results of operations in future periods.
For additional information, [removed: see *Results of Operations*] [added: refer to Notes 2, 4, 7, 11, 13, 15, and 17] in Part II.
The table below is a summary of the Company’s financial results for the year ended December 31, [removed: 2021] [added: 2022] compared to the prior year period:
| (In millions, except per share [removed: amounts and %s)] [added: amounts)] | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | Change | | | | | | [removed: % Change] | | |
| Total revenues | | | $ | [removed: 17,886.3] [added: 16,262.7] | | | | | $ | [removed: 11,946.0] [added: 17,886.3] | | | | | $ | [removed: 5,940.3] [added: (1,623.6)] | | | | | [removed: 50] | | [removed: %] |
| Gross profit | | | [removed: 5,575.5] [added: 6,497.0] | | | | | | [removed: 3,796.7] [added: 5,575.5] | | | | | | [removed: 1,778.8] [added: 921.5] | | | | | | [removed: 47] | | [removed: %] |
| [removed: Loss] [added: Earnings (loss)] from operations | | | [removed: (34.0)] [added: 1,614.9] | | | | | | [removed: (210.8)] [added: (34.0)] | | | | | | [removed: 176.8] [added: 1,648.9] | | | | | | [removed: nm] | | |
| [removed: Net loss] [added: U.S. GAAP net earnings (loss)] | | | [removed: (1,269.1)] [added: $] | [added: 2,078.6] | | | | | [removed: (669.9)] | | | | | | [removed: (599.2)] [added: $] | [added: (1,269.1)] | | | | | [removed: (89)] | | [removed: %] | [added: | | | $ | (669.9) | | | | | | | |]
| Diluted [removed: loss] [added: earnings (loss)] per share | | | $ | [removed: (1.05)] [added: 1.71] | | | | | $ | [removed: (1.11)] [added: (1.05)] | | | | | $ | [removed: 0.06] [added: 2.76] | | | | | [removed: 5] | | [removed: %] |
| (In millions, except %s) | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | % Change | | | | | | [removed: 2021] [added: 2022] Currency Impact (1) | | | | | | [removed: 2021] [added: 2022] Constant Currency Revenues | | | | | | Constant Currency % Change (2) | | |
| Total net sales | | | [removed: 17,813.6] [added: 16,218.1] | | | | | | [removed: 11,819.9] [added: 17,813.6] | | | | | | [removed: 51] [added: (9)] | | % | | | | [removed: (206.4)] [added: 1,235.9] | | | | | | [removed: 17,607.2] [added: 17,454.0] | | | | | | [removed: 49] [added: (2)] | | % |
| Consolidated total revenues (4) | | | $ | [removed: 17,886.3] [added: 16,262.7] | | | | | $ | [removed: 11,946.0] [added: 17,886.3] | | | | | [removed: 50] [added: (9)] | | % | | | | $ | [removed: (207.4)] [added: 1,238.8] | | | | | $ | [removed: 17,678.9] [added: 17,501.5] | | | | | [removed: 48] [added: (2)] | | % |
(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: 2021] [added: 2022] constant currency net sales or revenues to the corresponding amount in the prior year.
(3)For the year ended December 31, [removed: 2021,] [added: 2022,] other revenues in Developed Markets, JANZ, and Emerging Markets were approximately [removed: $51.0] [added: $21.8] million, [removed: $1.5] [added: $1.4] million, and [removed: $20.2] [added: $21.4] million, respectively.
For the year ended December 31, [removed: 2021,] [added: 2022,] the Company reported total revenues of [removed: $17.89] [added: $16.26] billion, compared to [removed: $11.95] [added: $17.89] billion for the comparable prior year period, representing [removed: an increase] [added: a decrease] of [removed: $5.94] [added: $1.62] billion, or [removed: 50%.][added: 9%.]
Net sales for the year ended December 31, [removed: 2021] [added: 2022] were [removed: $17.81] [added: $16.22] billion, compared to [removed: $11.82] [added: $17.81] billion for the comparable prior year period, representing [removed: an increase] [added: a decrease] of [removed: $5.99] [added: $1.60] billion, or [removed: 51%.][added: 9%.]
Other revenues for the year ended December 31, [removed: 2021] [added: 2022] were [removed: $72.7] [added: $44.6] million, compared to [removed: $126.1] [added: $72.7] million for the comparable prior year period, a decrease of [removed: $53.4] [added: $28.1] million.
The [removed: increase] [added: decrease] in net sales was primarily driven by the [removed: incremental net sales from the Upjohn Business totaling $5.80 billion and the favorable] [added: unfavorable] impact of foreign currency [removed: translation,] [added: translation of approximately $1.24 billion, or 7%,] primarily reflecting changes in the U.S. Dollar as compared to the currencies of subsidiaries in countries within the EU, [removed: of approximately $206.4 million, or 2%.][added: Japan and India.]
[added: The decrease in net sales from existing products was partially offset by approximately $483.1 million of new product sales, primarily in the U.S.] New product sales include new products launched in [removed: 2021] [added: 2022] and the carryover impact of new products, including business development, launched within the last twelve months.
Generally, this is due to the timing of new product [removed: introductions] [added: introductions, seasonality,] and the amount, if any, of additional competition in the market.
Our top ten products in terms of net sales, in the aggregate, represented [removed: approximately] 33% [removed: and 23%] for the years ended December 31, [removed: 2021] [added: 2022] and [removed: 2020, respectively, with the year over year increase a result of the Combination.][added: 2021.]
Net sales from Developed Markets [removed: increased] [added: decreased] by [removed: $1.92 billion] [added: $659.8 million] or [removed: 23%] [added: 6%] during the year ended December 31, [removed: 2021] [added: 2022] when compared to the prior year.
Net sales within North America totaled approximately [removed: $4.59] [added: $4.34] billion and net sales within Europe totaled approximately [removed: $5.84] [added: $5.43] billion.
This increase was partially offset by [removed: lower pricing] [added: the year over year impact of the sale of the biosimilars business,] and [removed: volumes on] [added: lower] net sales of existing [removed: products, including Wixela® Inhub®, Perforomist®, Xulane®, and Miacalcin® within] [added: products in] the U.S., [added: including Miacalcin®, Wixela Inhub® and Perforomist®, as a result of lower pricing and, to a lesser extent, volumes] due to additional competition.
- impairment charges or other losses related to the divestiture or sale of businesses or assets;
*Ophthalmology Acquisitions*
During the first quarter of 2023, the Company completed the acquisition of Oyster Point for approximately $425 million in cash, which includes $11 per share paid to Oyster Point stockholders through a tender offer and the repayment of the principal amount of certain debt of Oyster Point.
In addition to the upfront cash consideration, each Oyster Point stockholder received one non-tradeable contingent value right representing up to an additional $2 per share, or approximately $60 million in the aggregate, contingent upon Oyster Point achieving certain metrics based upon full year 2022 performance, which are expected to be determined by the end of the first quarter of 2023.
Oyster Point is a commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases.
On November 7, 2022, the Company entered into a definitive agreement to acquire the remaining equity shares of Famy Life Sciences, a private-owned research company with a complementary portfolio of ophthalmology therapies under development, for a consideration of $281 million.
The Company had previously entered into a Master Development Agreement with Famy Life Sciences on December 20, 2019 to grant the Company rights with respect to acquiring certain pharmaceutical products and had additionally acquired shares representing approximately 13.5% equity interest in Famy Life Sciences for $25.0 million during the year ended December 31, 2020.
The transaction to acquire the remaining equity shares of Famy Life Sciences closed during the first quarter of 2023.
The accounting impact of the Oyster Point and Famy Life Sciences acquisitions and the results of the operations for Oyster Point and Famy Life Sciences will be included in our consolidated financial statements beginning in the first quarter of 2023.
Item 8 of this Form 10-K for more information.
Such repurchases may be made from time-to-time at the Company’s discretion and effected by any means, including but not limited to, open market repurchases, pursuant to plans in accordance with Rules 10b5-1 or 10b-18 under the Exchange Act, privately negotiated transactions (including accelerated stock repurchase programs) or any combination of such methods as the Company deems appropriate.
The program does not have an expiration date.
During 2022, the Company did not repurchase any shares of common stock under the share repurchase program.
In January and February 2023, the Company repurchased approximately 21.2 million shares of common stock at a cost of approximately $250 million.
*International Operations*
The ongoing conflict between Russia and Ukraine did not have a material impact on our business as the combined total revenues for both countries were approximately 1% of consolidated total revenues during the years ended December 31, 2022 and 2021.
However, trade controls, sanctions, supply chain and staffing challenges and other economic considerations related to the conflict have impacted our operations in these markets and may negatively impact our financial results in future periods.
In addition, a significant escalation or expansion of the conflict’s current scope may have a negative impact on our operations and financial results in future periods.
For a further discussion of the risks we encounter in our business, including the risks of conducting our business internationally, please refer to *Risk Factors in* Part I, Item 1A of this Form 10-K.
Under ASC 830, Foreign Currency Matters (“ASC 830”), a highly inflationary economy is one that has cumulative inflation of approximately 100% or more over a three-year period.
Effective April 1, 2022, we classified Turkey as highly inflationary and began to utilize the U.S. dollar as our functional currency in Turkey, which historically utilized the Turkish lira as the functional currency.
Application of the guidance in ASC 830 did not have a material impact on our consolidated financial statements for the year ended December 31, 2022.
The impacted net sales for the year ended December 31, 2022 and total assets at December 31, 2022 represented less than 1% of our consolidated net sales and total assets, respectively.
The transaction subsequently closed on November 29, 2022, creating what Viatris expects to be a unique fully vertically integrated global biosimilars leader.
Under the terms of the Biocon Agreement, Viatris received $3 billion in consideration in the form of a $2 billion cash payment, adjusted as set forth in the Biocon Agreement, and approximately $1 billion of CCPS representing a stake of approximately 12.9% (on a fully diluted basis) in Biocon Biologics.
Viatris also is entitled to $335 million of additional cash payments in 2024.
In addition, Viatris and Biocon Biologics have agreed to a closing working capital target of $250 million.
An amount of cash equal to all or a portion of the closing working capital target may become payable to Biocon Biologics in connection with certain events in the future, depending on the valuations attributable to such events.
Upon closing of the transaction, the Company recognized a gain on sale of approximately $1.75 billion and has not recognized the results of the business in its consolidated financial statements subsequent to November 29, 2022.
Viatris and Biocon Biologics also entered an agreement pursuant to which Viatris is providing commercialization and certain other transition services on behalf of Biocon Biologics, including billings, collections and the remittance of rebates, to ensure business continuity for patients, customers and colleagues.
The term of the transition services agreement is generally up to two years.
Under the transition services agreement, Viatris is entitled to be reimbursed for its costs (subject to certain caps) plus a markup.
through potential prevention and treatment efforts, supporting the communities in which we operate and maintaining the health of our overall business.
In addressing the COVID-19 pandemic and helping meet urgent global health needs, tens of thousands of dedicated Viatris employees across the world have worked to help ensure a stable supply of much needed treatments.
Because protecting the health and safety of our workforce remains paramount, we continue to align with government directives and the advice of relevant international, national and local health authorities at every Viatris facility around the world.
2022 Compared to 2021
| Developed Markets | | | $ | 9,768.9 | | | | | $ | 10,428.7 | | | | | (6) | | % | | | | $ | 666.6 | | | | | $ | 10,435.5 | | | | | — | | % |
| Greater China | | | 2,201.2 | | | | | | 2,212.8 | | | | | | (1) | | % | | | | 73.8 | | | | | | 2,275.1 | | | | | | 3 | | % |
| JANZ | | | 1,632.4 | | | | | | 2,027.4 | | | | | | (19) | | % | | | | 230.8 | | | | | | 1,863.2 | | | | | | (8) | | % |
| Emerging Markets | | | 2,615.6 | | | | | | 3,144.7 | | | | | | (17) | | % | | | | 264.7 | | | | | | 2,880.2 | | | | | | (8) | | % |
- the integration of Mylan and the Upjohn Business or the implementation of the Company’s global restructuring program being more difficult, time consuming or costly than expected;
- the pending Biocon Biologics Transaction may not achieve its intended benefits;
- the possibility that the Company may be unable to successfully integrate Mylan and the Upjohn Business or implement its global restructuring program;
- operational or financial difficulties or losses associated with the Company’s reliance on agreements with Pfizer in connection with the Combination, including with respect to transition services;
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).
*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®.
Viatris’ restructuring initiative incorporates and expands on the restructuring program announced by Mylan N.V. earlier in 2020 as part of its business transformation efforts.
Current inventory levels, both ours and those in our distribution channel, remain in-line with normal levels.
Item 7.
| 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 | | % |
| Other revenues (3) | | | 72.7 | | | | | | 126.1 | | | | | | (42) | | % | | | | (1.0) | | | | | | 71.7 | | | | | | (43) | | % |
New product sales of $698.7 million were offset by a decrease in net sales from existing products as a result of lower pricing and volumes of $710.9 million.
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 percentage may fluctuate based upon the timing of new product launches, seasonality and the impact of competition.
This increase was primarily the result of the incremental net sales from the Upjohn Business in the current year of $1.83 billion and new product sales, including the portfolio of thrombosis products in Europe acquired from Aspen in the fourth quarter of 2020.
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.
The favorable impact of foreign currency translation on current period net sales was approximately $185.1 million, or 2%.
This increase was primarily the result of the incremental net sales from the Upjohn Business of $1.93 billion.
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 pricing driven by government price reductions and product competition.
Foreign currency translation had a favorable impact of approximately $2.7 million, or less than 1%.
This increase was primarily the result of the incremental net sales from the Upjohn Business of $1.37 billion and COVID-19 related product sales in India, primarily remdesivir and ambisome.
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.
The increase in net sales was partially offset by the favorable impact of foreign currency translation of $9.3 million, or less than 1%.
Constant currency net sales increased by approximately $1.28 billion, or 69%.
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.
An excerpt. Shown here: 40 of 207 rewritten, 40 of 128 added and 40 of 93 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 FY2022 filing and the FY2021 filing.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
3 rewritten, 5 added, 0 removed, 22 unchanged
As of December 31, [removed: 2021,] [added: 2022,] Viatris’ outstanding fixed rate borrowings consist principally of [removed: $20.60] [added: $18.41] billion notional amount of senior U.S. dollar and Euro notes.
As of December 31, [removed: 2021,] [added: 2022,] the fair value of our outstanding fixed rate senior U.S. dollar and Euro notes was approximately [removed: $22.01] [added: $15.36] 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: $18.4] [added: $3.1] million per year.
As of December 31, 2022, Viatris’ outstanding variable rate borrowings consist principally of borrowings under the Yen Term Loan Facility of $305.1 million.
*Fair Value Risk*
The Company’s fair value risk exposure relates primarily to our equity investments that do not have readily determinable fair values, principally the CCPS received as part of the Biocon Biologics Transaction.
As of December 31, 2022 and 2021, the carrying value of these investments were approximately $1.09 billion and $81.4 million, respectively.
A hypothetical 20 percent decline in the fair value of these investments would have decreased the carrying value and other (income) expense, net by approximately $218.0 million at December 31, 2022.
Item 1. Business
70 rewritten, 93 added, 32 removed, 246 unchanged
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 [added: key] stakeholders.
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 [added: an] 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, generics, [added: and] complex generics, [removed: and biosimilars.][added: including biosimilars prior to the Biocon Biologics Transaction.]
Prior to the [removed: Separation,] [added: separation of] the [added: Upjohn Business from the remainder of Pfizer’s businesses, the] legacy Upjohn Business historically received support services from Pfizer.
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: 2021.][added: 2022.]
Viatris product and other company data included in this Item 1 are from internal sources and are as of November 30, [removed: 2021.][added: 2022.]
The Upjohn Business was a global, primarily off-patent branded and generic established medicines business, which included 20 primarily off-patent [removed: solid] oral [added: solid] dose legacy brands, such as Lyrica®, Lipitor®, Celebrex® and Viagra®.
Item 8 of this Form [removed: 10-K.][added: 10-K for more information.]
[removed: ][added: ]
Our global portfolio, supported by our science, medical and manufacturing expertise, delivers global iconic and key brands, complex generics, [removed: biosimilars, generics -] including [removed: complex and branded] [added: biosimilars prior to the Biocon Biologics Transaction,] generics [removed: -] and [removed: over-the-counter] [added: OTC] products.
- 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, [removed: were] [added: are] among the leading causes of death [removed: globally as of 2016.][added: globally.]
[removed: 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.
Our confidence in the future delivery of our pipeline is rooted in our strong historic development programs and list of firsts, including the [removed: recent approval] [added: first FDA approvals] of the generic version of Allergan's Restasis® and [removed: Semglee® (insulin glargine-yfgn),] the [removed: first interchangeable biosimilar ever approved in the U.S., and the launch] [added: generic version] of [removed: the first biosimilar to Humira® (adalimumab) in Japan.][added: Symbicort®, Breyna™.]
In addition, we are working on many other programs, including the potential to be first to market for our [removed: BOTOX® (onabotulinumtoxinA)] [added: generics of Abilify Maintena®, Injectafer®, Invega Trinza®, Ozempic®, Sandostin® LAR Depot, Venofer®] and [removed: Eylea® (aflibercept) biosimilars.][added: Wegovy™.]
[removed: Complex] [added: We believe complex] products categories are critical to patient health and are growing at a rapid pace.
[removed: ][added: ]
Our efforts to build a responsive global network have helped us maintain a reliable supply of much needed medicines [removed: as the fight against] [added: during] the COVID-19 [removed: pandemic continues.][added: pandemic.]
We are committed to advancing responsible and sustainable operations and work diligently to minimize our environmental footprint across the Viatris [removed: network while safeguarding access to medicine.]
- Diverse and differentiated global portfolio includes products in more than 10 major therapeutic areas, including both infectious diseases and NCDs and medicines that treat [removed: 9 out of] [added: the top] 10 of the WHO’s leading causes of [removed: death.][added: death globally.]
[removed: ][added: ]
[removed: 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 [removed: groups.][added: groups to promote sustainable access to treatment, build more resilient healthcare systems and drive these issues within our industry on global, regional and local levels.]
[removed: Our key] [added: Many of our] collaborations focus on access to medicine; public awareness and disease screening; and healthcare [removed: provider] [added: professional] education and support.
Our Global Healthcare [removed: Gateway®] [added: Gateway®] is open for business.
[removed: Although] [added: With] the global platforms and infrastructure supporting our innovative Global Healthcare [removed: Gateway are not entirely new, what is new is how] [added: Gateway®,] 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.
Our significant licensing and other partner agreements are primarily focused on the development, manufacturing, supply and commercialization of multiple, high-value generic [removed: biosimilar compounds, insulin analog products] [added: compounds] and respiratory products, among other complex products.
Refer to Note [removed: 18] [added: 19] *Licensing and Other Partner Agreements* included in Part II.
The manufacturing of APIs and finished dosage forms is [added: currently] performed by a combination of internal and external manufacturing operations.
Internally, many of the products we produce are [added: currently] vertically integrated; meaning we manufacture both the APIs and finished dosage forms related to those products.
The Company’s significant manufacturing, warehousing and distribution activities are located primarily in the U.S., Puerto Rico, Singapore, India, [removed: Japan,] [added: Australia,] China, and certain E.U. countries, including Ireland.
We work systematically and diligently to minimize our environmental [removed: footprint.][added: footprint while seeking to safeguard stable access to medicine.]
While it is [removed: impossible] [added: very hard] to predict accurately the future costs associated with [removed: environmental] compliance [removed: and potential remediation activities, compliance] with environmental [removed: laws] [added: laws, this] is not expected to require significant capital expenditures and has not had, and is not expected to have, a material adverse effect on our operations or competitive position.
The table below displays the percentage of consolidated net sales to our largest customers during the years ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019.][added: 2020.]
| | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |
| McKesson Corporation | | | [removed: 9] [added: 11] | | % | | | | [removed: 13] [added: 9] | | % | | | | [removed: 15] [added: 13] | | % |
| AmerisourceBergen Corporation | | | [removed: 9] [added: 10] | | % | | | | [removed: 10] [added: 9] | | % | | | | [removed: 9] [added: 10] | | % |
| Cardinal Health, Inc. | | | 5 | | % | | | | [removed: 8] [added: 5] | | % | | | | 8 | | % |
Viatris [added: currently] markets prescription brand drugs, generic drugs, complex generic drugs, [removed: biosimilars] and APIs.
Viatris has numerous branded drugs, including iconic brands, as well as several global [removed: key brands to help patients manage their health.]
Viatris offers a number of these important medicines to patients, including our [removed: Wixela®] [added: Wixela] Inhub®, the first generic of ADVAIR DISKUS® and glatiramer acetate injection, a generic version of Copaxone®, for example.
Our [removed: API is] [added: APIs are] sold through a dedicated sales and marketing team primarily to pharmaceutical companies throughout the world.
As a result of the Combination, Viatris held the combined Upjohn Business and Mylan business and Mylan ceased to exist as a separate legal entity after merging with and into Mylan II B.V., an indirect wholly owned subsidiary of Viatris.
Refer to Note 4 *Acquisitions and Other Transactions* included in Part II.
By the end of 2022, the Company had exited substantially all transition services with Pfizer.
In February 2022, the Company announced plans for certain strategic actions, anchored by a significant global reshaping initiative designed to unlock trapped value and provide the financial flexibility required to deliver on its vision.
The Company also announced that it had entered into a strategic transaction with Biocon Biologics to create what it expects to be a vertically integrated global biosimilars leader, as well as potential plans to divest other select assets no longer considered core to our future strategy to help reshape the Company.
On February 27, 2022, Viatris entered into a definitive agreement with Biocon Biologics to contribute its biosimilars portfolio to Biocon Biologics.
The transaction subsequently closed on November 29, 2022.
Under the terms of the Biocon Agreement, Viatris received $3 billion in consideration in the form of a $2 billion cash payment, adjusted as set forth in the Biocon Agreement, and approximately $1 billion of CCPS representing a stake of approximately 12.9% (on a fully diluted basis) in Biocon Biologics.
Viatris also is entitled to $335 million of additional cash payments in 2024.
In addition, Viatris and Biocon Biologics have agreed to a closing working capital target of $250 million.
An amount of cash equal to all or a portion of the closing working capital target may become payable to Biocon Biologics in connection with certain events in the future, depending on the valuations attributable to such events.
Upon closing of the transaction, the Company recognized a gain on sale of approximately $1.75 billion and has not recognized the results of the business in its consolidated financial statements subsequent to November 29, 2022.
Viatris and Biocon Biologics also entered an agreement pursuant to which Viatris is providing commercialization and certain other transition services on behalf of Biocon Biologics, including billings, collections and the remittance of rebates, to ensure business continuity for patients, customers and colleagues.
The term of the transition services agreement is generally up to two years.
Under the transition services agreement, Viatris is entitled to be reimbursed for its costs (subject to certain caps) plus a markup.
In November 2022, the Company provided an update on the strategic priorities announced in February 2022, including identifying the following businesses no longer considered core to its future strategy that the Company intends to divest:
- OTC;
- API (while retaining some selective development API capabilities);
- Women’s health care, primarily related to our oral and injectable contraceptives.
This does not include all of our women’s health care related products; as an example, our Xulane® product in the U.S. is excluded; and
- Upjohn Distributor Markets.
During the first quarter of 2023, the Company completed the acquisition of Oyster Point for approximately $425 million in cash, which includes $11 per share paid to Oyster Point stockholders through a tender offer and the repayment of the principal amount of certain debt of Oyster Point.
In addition to the upfront cash consideration, each Oyster Point stockholder received one non-tradeable contingent value right representing up to an additional $2 per share, or approximately $60 million in the aggregate, contingent upon Oyster Point achieving certain metrics based upon full year 2022 performance, which are expected to be determined by the end of the first quarter of 2023.
Oyster Point is a commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases.
On November 7, 2022, the Company entered into a definitive agreement to acquire the remaining equity shares of Famy Life Sciences, a private-owned research company with a complementary portfolio of ophthalmology therapies under development, for a consideration of $281 million.
The Company had previously entered into a Master Development Agreement with Famy Life Sciences on December 20, 2019 to grant the Company rights with respect to acquiring certain pharmaceutical products and had additionally acquired shares representing approximately 13.5% equity interest in Famy Life Sciences for $25.0 million during the year ended December 31, 2020.
The transaction to acquire the remaining equity shares of Famy Life Sciences closed during the first quarter of 2023.
Ophthalmology is one of the key therapeutic areas of focus that the Company announced in February 2022.
With the combination of Viatris' global commercial footprint, R&D and regulatory capabilities and supply chain, along with Oyster Point's deep knowledge of the ophthalmology space from a clinical, medical, regulatory and commercial perspective—including a commercial asset, Tyrvaya®, for the treatment of dry eye disease—and Famy Life Sciences' Phase III-ready pipeline, the Company believes it has the foundation to create a leading global ophthalmology franchise, accelerating efforts to address the unmet needs of patients with ophthalmic disease and the eye care professionals who treat them.
The Eye Care division within the company will be led by former Oyster Point CEO, Jeff Nau Ph.D.
We see access as fundamental to empowering people worldwide to live healthier at every stage of life—a powerful concept in challenging times.
It begins with our efforts to sustainably deliver high-quality medicines and health solutions at scale to people, regardless of geography or circumstance.
As a healthcare company born during a global pandemic, Viatris was formed to bridge the traditional divide between generics and brands, aiming to combine the best of both, to more holistically address healthcare needs globally.
With an extensive portfolio of medicines to meet nearly every health need, a one-of-a-kind global supply chain designed to reach more people with health solutions when and where they need them, and the scientific expertise to address some of the world’s most enduring health challenges, access takes on deeper meaning at Viatris.
From our unique vantage point, we touch all of life’s moments, from birth to end of life, acute conditions to chronic diseases.
We see across multiple therapeutic areas to the person at the center of their own unique health journey.
We are focused on meeting individual needs, whether with a generic medicine, an improved version of an existing medicine, or a truly novel therapeutic solution.
Ultimately, we know we are stronger together.
Both as a company and as a global community.
Our pursuit of access is relentless.
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 “Combination”).
In addition, pursuant to the SDA and immediately prior to the Distribution, Viatris made a cash payment to Pfizer equal to $12 billion as partial consideration for the Contribution.
As a result of the Combination, Viatris holds the combined Upjohn Business and Mylan business.
Upon completion of the Distribution and the Combination, holders of Pfizer’s common stock as of the Record Date owned approximately 57% of the outstanding shares of Viatris common stock, and former Mylan shareholders owned approximately 43% of the outstanding shares of Viatris common stock, in each case on a fully diluted, as-converted and as-exercised basis.
In connection with the Combination, on November 16, 2020, Mylan merged with and into Mylan II B.V., a company incorporated under the laws of the Netherlands and an indirect wholly owned subsidiary of Viatris, pursuant to and in accordance with the BCA.
As a result of such merger, Mylan ceased to exist as a separate legal entity.
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.
For additional information, see “Risk Factors – *Viatris could incur operational difficulties or losses if 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, or if we are required to make payments to Pfizer pursuant to indemnities agreed to as part of the Combination.*”
This includes our previously disclosed significant global restructuring program, which is described further in Note 17 included in Part II.
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.
Our integrated, comprehensive approach focuses on water, air emissions, waste, climate change and energy.
We also are a leading provider of biosimilars globally, with regulatory approvals for biosimilars in more than 85 countries in the areas of oncology, immunology, endocrinology, ophthalmology and dermatology.
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.
Looking ahead, to help ensure we identify and manage risks and opportunities appropriately, we are conducting a climate scenario analysis and intend to establish science-based greenhouse gas reduction targets and strategies, acknowledging the context of the Paris Agreement, as well as goals for water and waste.
*Biosimilars* are approved by regulatory authorities as highly similar to the originally approved biologic brand version with no clinically meaningful differences in safety or efficacy.
Biosimilar versions are increasingly available as therapeutic alternatives for patients facing many serious diseases, including diabetes, autoimmune disorders and multiple cancers.
We offer one of the industry’s largest and most diverse global biosimilars franchises with more than 300 marketing authorizations globally focused on the areas of oncology, immunology, endocrinology, ophthalmology and dermatology.
These vital products can help increase access for current and future patients while supporting the sustainability of healthcare systems, and we continue to invest in bringing more to market, as we believe more than two-thirds of the products we will launch in the coming years will be either complex generics or biosimilars.
Biosimilars often are marketed under a brand-name.
Viatris offers one of the industry’s largest and most diverse global biosimilars franchises, including Fulphila®, Ogivri®, Hulio®, and SEMGLEE®.
New product launches are an important growth driver.
Important recent launches include adalimumab biosimilar in Japan.
New products sold in the Emerging Markets segment in 2021 include Remdesivir and a number of biosimilars.
- Establishing four inaugural Employee Resource Groups (ERGs): Blacks, Women, LGBTQ+ and Working Parents.
We believe that it is only through the diverse experiences and perspectives of all our colleagues that we can elicit the best ideas, drive innovation, and achieve business results; and
- Being recognized on the Forbes® 2021 World’s Best Employers list.
We are committed to cultivating and acquiring talent, developing capabilities and driving performance.
We are systematically reviewing and developing structures, programs and processes to support colleagues’ professional development and ensure that Viatris contains the appropriate competencies to support our mission.
Others have traded their desks for kitchen tables and are juggling disrupted family schedules as well as work, like so many, during this time.
*Approach to restructuring*
Viatris is undertaking a global restructuring program intended to ensure that the organization is optimally structured and efficiently resourced to deliver sustainable value to patients, shareholders, customers, and other stakeholders.
Any workforce actions taken as part of this restructuring program have been and will continue to be implemented in a way that is consistent with the company’s strong commitment to treating employees fairly and with respect.
An excerpt. Shown here: 40 of 70 rewritten, 40 of 93 added and all 32 removed. The counts are complete. For every sentence, read Item 1. Business in the FY2022 filing and the FY2021 filing.
Item 3. Legal Proceedings
1 rewritten, 0 added, 0 removed, 0 unchanged
For information regarding legal proceedings, refer to Note [removed: 19] [added: 20] *Litigation* included in Item 8 in Part II of this 10-K.
Cover and table of contents
38 rewritten, 12 added, 19 removed, 206 unchanged
| | | | For the Fiscal Year Ended December 31, [removed: 2021] [added: 2022] | | |
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant as of June 30, [removed: 2021,] [added: 2022,] the last business day of the registrant’s most recently completed second fiscal quarter, was approximately [removed: $17,237,737,213.][added: $12,662,127,991.]
The number of shares of common stock outstanding, par value $0.01 per share, of the registrant as of February [removed: 22, 2022] [added: 21, 2023] was [removed: 1,209,576,280.][added: 1,196,813,959.]
For the Year Ended December 31, [removed: 2021][added: 2022]
| ITEM 1. | | | [removed: [Business](#ie2fdfbf3ed474f27b20ef16155bfdf72_13)] [added: [Business](#i7434bb1a8ab040e887ebfe503bff36b7_13)] | | | [removed: [9](#ie2fdfbf3ed474f27b20ef16155bfdf72_13)] [added: [8](#i7434bb1a8ab040e887ebfe503bff36b7_13)] | | |
| ITEM 1A. | | | [Risk [removed: Factors](#ie2fdfbf3ed474f27b20ef16155bfdf72_82)] [added: Factors](#i7434bb1a8ab040e887ebfe503bff36b7_82)] | | | [removed: [20](#ie2fdfbf3ed474f27b20ef16155bfdf72_82)] [added: [20](#i7434bb1a8ab040e887ebfe503bff36b7_82)] | | |
| ITEM 1B. | | | [Unresolved Staff [removed: Comments](#ie2fdfbf3ed474f27b20ef16155bfdf72_85)] [added: Comments](#i7434bb1a8ab040e887ebfe503bff36b7_85)] | | | [removed: [52](#ie2fdfbf3ed474f27b20ef16155bfdf72_85)] [added: [48](#i7434bb1a8ab040e887ebfe503bff36b7_85)] | | |
| ITEM 2. | | | [removed: [Properties](#ie2fdfbf3ed474f27b20ef16155bfdf72_88)] [added: [Properties](#i7434bb1a8ab040e887ebfe503bff36b7_88)] | | | [removed: [52](#ie2fdfbf3ed474f27b20ef16155bfdf72_88)] [added: [48](#i7434bb1a8ab040e887ebfe503bff36b7_88)] | | |
| ITEM 3. | | | [Legal [removed: Proceedings](#ie2fdfbf3ed474f27b20ef16155bfdf72_91)] [added: Proceedings](#i7434bb1a8ab040e887ebfe503bff36b7_91)] | | | [removed: [52](#ie2fdfbf3ed474f27b20ef16155bfdf72_91)] [added: [48](#i7434bb1a8ab040e887ebfe503bff36b7_91)] | | |
| ITEM 4. | | | [Mine Safety [removed: Disclosures](#ie2fdfbf3ed474f27b20ef16155bfdf72_1099511630152)] [added: Disclosures](#i7434bb1a8ab040e887ebfe503bff36b7_94)] | | | [removed: [52](#ie2fdfbf3ed474f27b20ef16155bfdf72_1099511630152)] [added: [48](#i7434bb1a8ab040e887ebfe503bff36b7_94)] | | |
| ITEM 5. | | | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#ie2fdfbf3ed474f27b20ef16155bfdf72_97)] [added: Securities](#i7434bb1a8ab040e887ebfe503bff36b7_100)] | | | [removed: [53](#ie2fdfbf3ed474f27b20ef16155bfdf72_97)] [added: [49](#i7434bb1a8ab040e887ebfe503bff36b7_100)] | | |
| ITEM 7. | | | [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#ie2fdfbf3ed474f27b20ef16155bfdf72_103)] [added: Operations](#i7434bb1a8ab040e887ebfe503bff36b7_109)] | | | [removed: [55](#ie2fdfbf3ed474f27b20ef16155bfdf72_103)] [added: [51](#i7434bb1a8ab040e887ebfe503bff36b7_109)] | | |
| ITEM 7A. | | | [Quantitative and Qualitative Disclosures about Market [removed: Risk](#ie2fdfbf3ed474f27b20ef16155bfdf72_139)] [added: Risk](#i7434bb1a8ab040e887ebfe503bff36b7_148)] | | | [removed: [77](#ie2fdfbf3ed474f27b20ef16155bfdf72_139)] [added: [73](#i7434bb1a8ab040e887ebfe503bff36b7_148)] | | |
| ITEM 8. | | | [Financial Statements and Supplementary [removed: Data](#ie2fdfbf3ed474f27b20ef16155bfdf72_142)] [added: Data](#i7434bb1a8ab040e887ebfe503bff36b7_151)] | | | [removed: [78](#ie2fdfbf3ed474f27b20ef16155bfdf72_142)] [added: [75](#i7434bb1a8ab040e887ebfe503bff36b7_151)] | | |
| ITEM 9. | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#ie2fdfbf3ed474f27b20ef16155bfdf72_250)] [added: Disclosure](#i7434bb1a8ab040e887ebfe503bff36b7_259)] | | | [removed: [148](#ie2fdfbf3ed474f27b20ef16155bfdf72_250)] [added: [144](#i7434bb1a8ab040e887ebfe503bff36b7_259)] | | |
| ITEM 9A. | | | [Controls and [removed: Procedures](#ie2fdfbf3ed474f27b20ef16155bfdf72_253)] [added: Procedures](#i7434bb1a8ab040e887ebfe503bff36b7_262)] | | | [removed: [148](#ie2fdfbf3ed474f27b20ef16155bfdf72_253)] [added: [144](#i7434bb1a8ab040e887ebfe503bff36b7_262)] | | |
| ITEM 9B. | | | [Other [removed: Information](#ie2fdfbf3ed474f27b20ef16155bfdf72_256)] [added: Information](#i7434bb1a8ab040e887ebfe503bff36b7_265)] | | | [removed: [148](#ie2fdfbf3ed474f27b20ef16155bfdf72_256)] [added: [144](#i7434bb1a8ab040e887ebfe503bff36b7_265)] | | |
| ITEM 9C. | | | [Disclosure Regarding Foreign Jurisdictions that Prevent [removed: Inspections](#ie2fdfbf3ed474f27b20ef16155bfdf72_1099511630180)] [added: Inspections](#i7434bb1a8ab040e887ebfe503bff36b7_268)] | | | [removed: [148](#ie2fdfbf3ed474f27b20ef16155bfdf72_1099511630180)] [added: [144](#i7434bb1a8ab040e887ebfe503bff36b7_268)] | | |
| ITEM 10. | | | [Directors, Executive Officers and Corporate [removed: Governance](#ie2fdfbf3ed474f27b20ef16155bfdf72_262)] [added: Governance](#i7434bb1a8ab040e887ebfe503bff36b7_274)] | | | [removed: [149](#ie2fdfbf3ed474f27b20ef16155bfdf72_262)] [added: [145](#i7434bb1a8ab040e887ebfe503bff36b7_274)] | | |
| ITEM 11. | | | [Executive [removed: Compensation](#ie2fdfbf3ed474f27b20ef16155bfdf72_265)] [added: Compensation](#i7434bb1a8ab040e887ebfe503bff36b7_277)] | | | [removed: [149](#ie2fdfbf3ed474f27b20ef16155bfdf72_265)] [added: [145](#i7434bb1a8ab040e887ebfe503bff36b7_277)] | | |
| ITEM 12. | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#ie2fdfbf3ed474f27b20ef16155bfdf72_268)] [added: Matters](#i7434bb1a8ab040e887ebfe503bff36b7_280)] | | | [removed: [149](#ie2fdfbf3ed474f27b20ef16155bfdf72_268)] [added: [145](#i7434bb1a8ab040e887ebfe503bff36b7_280)] | | |
| ITEM 13. | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#ie2fdfbf3ed474f27b20ef16155bfdf72_271)] [added: Independence](#i7434bb1a8ab040e887ebfe503bff36b7_283)] | | | [removed: [149](#ie2fdfbf3ed474f27b20ef16155bfdf72_271)] [added: [145](#i7434bb1a8ab040e887ebfe503bff36b7_283)] | | |
| ITEM 14. | | | [Principal Accounting Fees and [removed: Services](#ie2fdfbf3ed474f27b20ef16155bfdf72_274)] [added: Services](#i7434bb1a8ab040e887ebfe503bff36b7_286)] | | | [removed: [149](#ie2fdfbf3ed474f27b20ef16155bfdf72_274)] [added: [145](#i7434bb1a8ab040e887ebfe503bff36b7_286)] | | |
| ITEM 15. | | | [Exhibits and Consolidated Financial Statement [removed: Schedules](#ie2fdfbf3ed474f27b20ef16155bfdf72_280)] [added: Schedules](#i7434bb1a8ab040e887ebfe503bff36b7_292)] | | | [removed: [150](#ie2fdfbf3ed474f27b20ef16155bfdf72_280)] [added: [146](#i7434bb1a8ab040e887ebfe503bff36b7_292)] | | |
Unless the context requires otherwise, references to “Viatris,” “the Company,” “we,” “us” or “our” in this [removed: 2021] [added: 2022] Form 10-K (defined below) refer to Viatris Inc. and its subsidiaries.
We also have used several other terms in this [removed: 2021] [added: 2022] Form 10-K, most of which are explained or defined below.
| 2003 LTIP | | | [added: Mylan N.V. Amended and Restated] 2003 Long-Term Incentive Plan | | |
| API | | | Active pharmaceutical [removed: ingredients] [added: ingredient] | | |
| Biocon Agreement | | | The [added: transaction] agreement between Viatris and Biocon Biologics, dated February [removed: 28,] [added: 27,] 2022, relating to the Biocon Biologics [added: Transaction, as amended by that certain Amendment No. 1 to] Transaction [added: Agreement, dated November 28, 2022] | | |
| Form 10-K | | | This annual report on Form 10-K for the fiscal year ended December 31, [removed: 2021] [added: 2022] | | |
| Note Securitization Facility | | | The note securitization facility entered into in [removed: July 2021] [added: August 2022] for borrowings up to $200 million and expiring in August [removed: 2022] [added: 2023] | | |
| [added: 2020 Incentive] Plan | | | Viatris Inc. 2020 Stock Incentive Plan | | |
| Receivables Facility | | | The $400 million accounts receivable entered into in August 2020 and expiring in April [removed: 2022] [added: 2025] | | |
| 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 [added: B.V.] and Utah Acquisition Sub Inc. | | |
| Senior U.S. Dollar Notes | | | The [removed: Registered] Upjohn U.S. Dollar Notes, the Utah U.S. Dollar Notes and the Mylan Inc. U.S. Dollar Notes, collectively | | |
| 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 [added: B.V.] and Utah Acquisition Sub Inc. | | |
| Upjohn U.S. Dollar Notes | | | Senior unsecured notes denominated in U.S. dollars and [added: originally] issued by Upjohn Inc. [added: or Viatris Inc.] pursuant to an indenture dated June 22, 2020 [added: and fully and unconditionally guaranteed by Mylan Inc., Mylan II B.V. and Utah Acquisition Sub Inc.] | | |
| YEN Term Loan Facility | | | The ¥40 billion term loan agreement dated as of July 1, 2021, by and among Viatris, [removed: Mizuho] [added: MUFG] Bank, Ltd. and [removed: MUFG] [added: Mizuho] Bank, Ltd., as administrative agent | | |
| ITEM 6. | | | [\[Reserved\]](#i7434bb1a8ab040e887ebfe503bff36b7_103) | | | [50](#i7434bb1a8ab040e887ebfe503bff36b7_103) | | |
| [Signatures](#i7434bb1a8ab040e887ebfe503bff36b7_295) | | | | | | [154](#i7434bb1a8ab040e887ebfe503bff36b7_295) | | |
| 505(b)(2) | | | A streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant and for which the applicant has not obtained right of reference. | | |
| Biocon Biologics Transaction | | | The transaction between Viatris and Biocon Biologics pursuant to which Viatris contributed its biosimilars portfolio, composed of the Biocon collaboration programs, biosimilars to Humira®, Enbrel®, and Eylea®, as well as related assets and liabilities to Biocon Biologics | | |
| CCPS | | | Compulsory convertible preferred shares | | |
| DRIP | | | Dividend Reinvestment and Share Purchase Plan | | |
| Famy Life Sciences | | | Famy Life Sciences Private Limited | | |
| NCEs | | | New Chemical Entities | | |
| OECD | | | The Organisation for Economic Co-operation and Development | | |
| Oyster Point | | | Oyster Point Pharma, Inc. | | |
| TSA | | | Transition services agreement | | |
| Upjohn Distributor Markets | | | Select geographic markets that were part of the Combination that are smaller in nature and in which we had no established infrastructure prior to or following the Combination and that the Company intends to divest | | |
| ITEM 6. | | | [\[Reserved\]](#ie2fdfbf3ed474f27b20ef16155bfdf72_2199023257942) | | | [54](#ie2fdfbf3ed474f27b20ef16155bfdf72_2199023257942) | | |
| [Signatures](#ie2fdfbf3ed474f27b20ef16155bfdf72_283) | | | | | | [159](#ie2fdfbf3ed474f27b20ef16155bfdf72_283) | | |
| 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 | | |
| BPCIA | | | Biologics Price Competition and Innovation Act of 2009 | | |
| CIA | | | Corporate Integrity Agreement, dated August 16, 2017, entered into between the OIG-HHA, Mylan Inc. and Mylan Specialty L.P. | | |
| CJEU | | | European Court of Justice | | |
| CMS | | | Centers for Medicare & Medicaid Services | | |
| Commission | | | European Commission | | |
| Contribution | | | Pfizer's contribution of the Upjohn Business to Viatris | | |
| EURIBOR | | | Euro Interbank Offered Rate | | |
| 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. | | |
| FCA | | | Financial Conduct Authority in the U.K. | | |
| IRS Ruling | | | The private letter ruling issued by the IRS to Pfizer with respect to the Combination, dated as of March 17, 2020 | | |
| Mylan II | | | Mylan 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 | | |
| OIG-HHS | | | Office of Inspector General of the Department of Health and Human Services | | |
| Pfizer Distribution Payments | | | Payments made by Pfizer using the proceeds of the $12 billion cash distribution to (a) repurchase Pfizer common stock, (b) make pro rata special cash distributions to its stockholders and/or (c) repay or repurchase debt (including principal, interest and associated premiums and fees) held by third party lenders | | |
| SOFR | | | Secured overnight financial rate | | |
| Tax Opinion | | | The tax opinion issued by Pfizer’s tax counsel, David Polk & Wardwell LLP, with respect to the Combination | | |
| TSA | | | Transition service agreements | | |
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
8 rewritten, 4 added, 11 removed, 10 unchanged
As of February [removed: 22, 2021,] [added: 21, 2023,] there were approximately [removed: 113,007] [added: 108,736] holders of record of shares of Viatris common stock.
On [removed: January 4, 2022,] [added: February 24, 2023,] 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 [removed: 16, 2022] [added: 17, 2023] to shareholders of record as of the close of business on [removed: February 24, 2022.][added: March 9, 2023.]
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: 2021.][added: 2022.]
[removed: ][added: ]
| | | | November 16, 2020 | | | | | | December 31, 2020 | | | | | | December 31, 2021 | | | [added: | | | December 31, 2022 | | |]
| Viatris Inc. | | | 100.00 | | | | | | 118.20 | | | | | | 87.32 | | | [added: | | | 74.84 | | |]
| S&P 500 | | | 100.00 | | | | | | 115.21 | | | | | | 148.28 | | | [added: | | | 121.43 | | |]
| Dow Jones U.S. Pharmaceuticals | | | 100.00 | | | | | | 113.12 | | | | | | 141.38 | | | [added: | | | 152.44 | | |]
The Company paid quarterly dividends of $0.12 per share on the Company’s issued and outstanding common stock on March 16, 2022, June 16, 2022, September 16, 2022 and December 16, 2022.
* $100 invested on November 16, 2020 in stock or October 31, 2020 in index, including reinvestment of dividends.
| | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
UNREGISTERED SALES OF DEBT SECURITIES
In the past three years, we have issued unregistered securities in connection with the following transactions:
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 2050 (collectively, the “Unregistered Upjohn U.S. Dollar Notes”).
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 September 2021, Viatris filed a registration statement with the SEC with respect to an offer to exchange up to $7.45 billion aggregate principal amount of Unregistered Upjohn U.S. Dollar Notes with Registered Upjohn Notes in the same aggregate principal amount and with terms substantially identical in all material respects, which was declared effective on September 28, 2021.
The exchange offer expired on October 28, 2021 and settled on October 29, 2021.
More than 99.9% of the aggregate principal amount of the Unregistered Upjohn U.S. Dollar Notes were exchanged for Registered Upjohn Notes.
In June 2020, Upjohn Finance B.V., a wholly owned financing subsidiary of Upjohn, issued €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.
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 8. Financial Statements And Supplementary Data
703 rewritten, 337 added, 339 removed, 1,156 unchanged
| [Management’s Report on Internal Control over Financial [removed: Reporting](#ie2fdfbf3ed474f27b20ef16155bfdf72_145)] [added: Reporting](#i7434bb1a8ab040e887ebfe503bff36b7_154)] | | | [removed: [79](#ie2fdfbf3ed474f27b20ef16155bfdf72_145)] [added: [76](#i7434bb1a8ab040e887ebfe503bff36b7_154)] | | |
| [Reports of Independent Registered Public Accounting [removed: Firm](#ie2fdfbf3ed474f27b20ef16155bfdf72_148) [](#ie2fdfbf3ed474f27b20ef16155bfdf72_148)] [added: Firm](#i7434bb1a8ab040e887ebfe503bff36b7_157)] (PCAOB ID No. 34) | | | [removed: [80](#ie2fdfbf3ed474f27b20ef16155bfdf72_148)] [added: [77](#i7434bb1a8ab040e887ebfe503bff36b7_157)] | | |
| [Consolidated Balance Sheets as of December 31, [removed: 202](#ie2fdfbf3ed474f27b20ef16155bfdf72_154)[1](#ie2fdfbf3ed474f27b20ef16155bfdf72_154)] [added: 202](#i7434bb1a8ab040e887ebfe503bff36b7_163)[2](#i7434bb1a8ab040e887ebfe503bff36b7_163)] [and [removed: 20](#ie2fdfbf3ed474f27b20ef16155bfdf72_154)[20](#ie2fdfbf3ed474f27b20ef16155bfdf72_154)] [added: 20](#i7434bb1a8ab040e887ebfe503bff36b7_163)[21](#i7434bb1a8ab040e887ebfe503bff36b7_163)] | | | [removed: [84](#ie2fdfbf3ed474f27b20ef16155bfdf72_154)] [added: [81](#i7434bb1a8ab040e887ebfe503bff36b7_163)] | | |
| [Consolidated Statements of Operations for the Years Ended December 31, [removed: 202](#ie2fdfbf3ed474f27b20ef16155bfdf72_157)[1](#ie2fdfbf3ed474f27b20ef16155bfdf72_157)[, 20](#ie2fdfbf3ed474f27b20ef16155bfdf72_157)[20](#ie2fdfbf3ed474f27b20ef16155bfdf72_157)[, and 201](#ie2fdfbf3ed474f27b20ef16155bfdf72_157)[9](#ie2fdfbf3ed474f27b20ef16155bfdf72_157)] [added: 202](#i7434bb1a8ab040e887ebfe503bff36b7_166)[2](#i7434bb1a8ab040e887ebfe503bff36b7_166)[, 202](#i7434bb1a8ab040e887ebfe503bff36b7_166)[1](#i7434bb1a8ab040e887ebfe503bff36b7_166) [and 2](#i7434bb1a8ab040e887ebfe503bff36b7_166)[021](#i7434bb1a8ab040e887ebfe503bff36b7_166)] | | | [removed: [85](#ie2fdfbf3ed474f27b20ef16155bfdf72_157)] [added: [82](#i7434bb1a8ab040e887ebfe503bff36b7_166)] | | |
| [Consolidated Statements of [removed: Comprehensive (Loss) Earnings for] [added: Comprehensive](#i7434bb1a8ab040e887ebfe503bff36b7_169) [Earnings](#i7434bb1a8ab040e887ebfe503bff36b7_169) [(Loss)](#i7434bb1a8ab040e887ebfe503bff36b7_169) [for] the Years Ended December 31, [removed: 202](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)[1](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)[, 20](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)[2](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)[0](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)] [added: 202](#i7434bb1a8ab040e887ebfe503bff36b7_169)[2](#i7434bb1a8ab040e887ebfe503bff36b7_169)[, 202](#i7434bb1a8ab040e887ebfe503bff36b7_169)[1](#i7434bb1a8ab040e887ebfe503bff36b7_169)] [and [removed: 201](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)[9](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)] [added: 2](#i7434bb1a8ab040e887ebfe503bff36b7_169)[02](#i7434bb1a8ab040e887ebfe503bff36b7_169)[0](#i7434bb1a8ab040e887ebfe503bff36b7_169)] | | | [removed: [86](#ie2fdfbf3ed474f27b20ef16155bfdf72_160)] [added: [83](#i7434bb1a8ab040e887ebfe503bff36b7_169)] | | |
| [Consolidated Statements of Equity for the Years Ended December 31, [removed: 202](#ie2fdfbf3ed474f27b20ef16155bfdf72_163)[1](#ie2fdfbf3ed474f27b20ef16155bfdf72_163)[, 20](#ie2fdfbf3ed474f27b20ef16155bfdf72_163)[20](#ie2fdfbf3ed474f27b20ef16155bfdf72_163)] [added: 202](#i7434bb1a8ab040e887ebfe503bff36b7_172)[2](#i7434bb1a8ab040e887ebfe503bff36b7_172)[, 202](#i7434bb1a8ab040e887ebfe503bff36b7_172)[1](#i7434bb1a8ab040e887ebfe503bff36b7_172)] [and [removed: 201](#ie2fdfbf3ed474f27b20ef16155bfdf72_163)[9](#ie2fdfbf3ed474f27b20ef16155bfdf72_163)] [added: 20](#i7434bb1a8ab040e887ebfe503bff36b7_172)[20](#i7434bb1a8ab040e887ebfe503bff36b7_172)] | | | [removed: [87](#ie2fdfbf3ed474f27b20ef16155bfdf72_163)] [added: [84](#i7434bb1a8ab040e887ebfe503bff36b7_172)] | | |
| [Consolidated Statements of Cash Flows for the Years Ended December 31, [removed: 202](#ie2fdfbf3ed474f27b20ef16155bfdf72_166)[1](#ie2fdfbf3ed474f27b20ef16155bfdf72_166)[, 20](#ie2fdfbf3ed474f27b20ef16155bfdf72_166)[20](#ie2fdfbf3ed474f27b20ef16155bfdf72_166)] [added: 202](#i7434bb1a8ab040e887ebfe503bff36b7_175)[2](#i7434bb1a8ab040e887ebfe503bff36b7_175)[, 202](#i7434bb1a8ab040e887ebfe503bff36b7_175)[1](#i7434bb1a8ab040e887ebfe503bff36b7_175)] [and [removed: 201](#ie2fdfbf3ed474f27b20ef16155bfdf72_166)[9](#ie2fdfbf3ed474f27b20ef16155bfdf72_166)] [added: 20](#i7434bb1a8ab040e887ebfe503bff36b7_175)[20](#i7434bb1a8ab040e887ebfe503bff36b7_175)] | | | [removed: [88](#ie2fdfbf3ed474f27b20ef16155bfdf72_166)] [added: [85](#i7434bb1a8ab040e887ebfe503bff36b7_175)] | | |
| [Notes to Consolidated Financial [removed: Statements](#ie2fdfbf3ed474f27b20ef16155bfdf72_169)] [added: Statements](#i7434bb1a8ab040e887ebfe503bff36b7_178)] | | | [removed: [89](#ie2fdfbf3ed474f27b20ef16155bfdf72_169)] [added: [86](#i7434bb1a8ab040e887ebfe503bff36b7_178)] | | |
As a result of this assessment, management has concluded that the Company maintained effective internal control over financial reporting as of December 31, [removed: 2021] [added: 2022] based on the criteria in *Internal Control - Integrated Framework (2013)* issued by COSO.
Deloitte & Touche LLP’s opinion on the Company’s internal control over financial reporting appears on page [removed: 83] [added: 80] of this Annual Report on Form 10-K.
We have audited the accompanying consolidated balance sheets of Viatris Inc. and subsidiaries (the "Company") as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] the related consolidated statements of operations, comprehensive [removed: (loss) earnings,] [added: earnings (loss),] equity, and cash flows, for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] and the related notes and the 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: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] 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: 2021,] [added: 2022,] based on criteria established in *Internal Control — Integrated Framework (2013)* issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February [removed: 28, 2022,] [added: 27, 2023,] expressed an unqualified opinion on the Company's internal control over financial reporting.
Goodwill – Viatris Inc. Europe and JANZ Reporting Units – Refer to Note [removed: 8] [added: 9] to the financial statements.
The Company performed [removed: its] [added: the] annual goodwill impairment test as of April 1, [removed: 2021.][added: 2022.]
As of [added: March 31, 2022 and] April 1, [removed: 2021,] [added: 2022,] the Company had [removed: $11.91] [added: $11.95] billion of consolidated goodwill, [removed: $5.15] [added: $4.95] billion and [removed: $0.82] [added: $0.78] billion of which was allocated to the Viatris Inc. Europe and JANZ reporting units, respectively.
The fair values of the Europe and the JANZ reporting units exceeded their carrying values by approximately [removed: $0.91] [added: $0.8] billion, or [removed: 5.8%,] [added: 5.3%,] and $0.23 billion, or [removed: 7.0%,] [added: 7.4%,] respectively, as of [added: March 31, 2022 and] April 1, [removed: 2021] [added: 2022] and, therefore, no impairments were recognized.
- We tested the effectiveness of controls over the review of the goodwill impairment [removed: test,] [added: tests,] including those over the development of the business forecasts of future revenues and the selection of the discount rates and terminal growth rates.
Net Revenue Provisions – [removed: Chargebacks] [added: Sales Returns] Accrual at [removed: Mylan Pharmaceuticals Inc. (“MPI”)] [added: MPI] – Refer to Note 3 to the financial statements.
The returns reserve at MPI represents a significant component of the global sales returns reserve as of December 31, [removed: 2021.][added: 2022.]
We have audited the internal control over financial reporting of Viatris, Inc. and subsidiaries (the “Company”) as of December 31, [removed: 2021,] [added: 2022,] 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: 2021,] [added: 2022,] 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: 2021,] [added: 2022,] of the Company and our report dated February [removed: 28, 2022,] [added: 27, 2023,] expressed an unqualified opinion on those financial statements.
| [added: (In millions)] | | | December 31, [added: 2022 | | | | | | December 31,] 2021 | | | | | | December 31, 2020 | | |
| Cash and cash equivalents | | | $ | [added: 1,259.9 | | | | | $ |] 701.2 | | | | | $ | 844.4 | |
| Accounts receivable, net | | | [removed: 4,266.4] [added: 3,814.5] | | | | | | [removed: 4,843.8] [added: 4,266.4] | | |
| Inventories | | | [removed: 3,977.7] [added: 3,519.5] | | | | | | [removed: 5,471.9] [added: 3,977.7] | | |
| Prepaid expenses and other current assets | | | [removed: 1,957.6] [added: 1,811.2] | | | | | | [removed: 1,707.4] [added: 1,957.6] | | |
| Total current assets | | | [removed: 10,902.9] [added: 10,635.4] | | | | | | [removed: 12,867.5] [added: 10,902.9] | | |
| Property, plant and equipment, net | | | [removed: 3,188.6] [added: 3,024.5] | | | | | | [removed: 3,459.9] [added: 3,188.6] | | |
| Intangible assets, net | | | [removed: 26,134.2] [added: 22,607.1] | | | | | | [removed: 29,683.2] [added: 26,134.2] | | |
| Goodwill | | | [removed: 12,113.7] [added: 10,425.8] | | | | | | [removed: 12,347.0] [added: 12,113.7] | | |
| Deferred income tax benefit | | | [removed: 1,332.7] [added: 925.9] | | | | | | [removed: 2,147.9] [added: 1,332.7] | | |
| Other assets | | | [removed: 1,170.7] [added: 2,403.5] | | | | | | [removed: 1,047.5] [added: 1,170.7] | | |
| Total assets | | | $ | [removed: 54,842.8] [added: 50,022.2] | | | | | $ | [removed: 61,553.0] [added: 54,842.8] | |
| Accounts payable | | | $ | [removed: 1,657.4] [added: 1,766.6] | | | | | $ | [removed: 1,904.2] [added: 1,657.4] | |
| Short-term borrowings | | | [removed: 1,493.0] [added: —] | | | | | | [removed: 1,100.9] [added: 1,493.0] | | |
| Income taxes payable | | | [removed: 236.9] [added: 279.6] | | | | | | [removed: 288.6] [added: 236.9] | | |
| Current portion of long-term debt and other long-term obligations | | | [removed: 1,877.5] [added: 1,259.1] | | | | | | [removed: 2,308.5] [added: 1,877.5] | | |
| Other current liabilities | | | [removed: 4,619.6] [added: 3,440.9] | | | | | | [removed: 4,960.7] [added: 4,619.6] | | |
The Company performed an interim and annual goodwill impairment test as of March 31, 2022 and April 1, 2022, respectively.
February 27, 2023
February 27, 2023
| Assets held for sale | | | 230.3 | | | | | | — | | |
| Research and development | | | 662.2 | | | | | | 681.0 | | | | | | 512.6 | | |
| Acquired IPR&D | | | 36.4 | | | | | | 70.1 | | | | | | 42.5 | | |
| Issuance of restricted stock, net | | | 3,972,427 | | | | | | — | | | | | | 1.6 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | | | | | | 1.6 | | | | | |
| Issuance of common stock | | | 313,341 | | | | | | — | | | | | | 3.3 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | | | | | | 3.3 | | | | | |
| Cash dividends declared, $0.48 per common share | | | — | | | | | | — | | | | | | — | | | | | | (591.8) | | | | | | — | | | | | | — | | | | | | — | | | | | | | | | | | | (591.8) | | | | | |
| Balance at December 31, 2022 | | | 1,213,793,231 | | | | | | $ | 12.1 | | | | | $ | 18,645.8 | | | | | $ | 5,175.6 | | | | | — | | | | | | $ | — | | | | | $ | (2,761.2) | | | | | | | | | | | $ | 21,072.3 | | | | |
| Net earnings (loss) | | | $ | 2,078.6 | | | | | $ | (1,269.1) | | | | | $ | (669.9) | |
| Gain on disposal of business | | | (1,754.1) | | | | | | — | | | | | | — | | |
| Issuance of common stock | | | 3.3 | | | | | | — | | | | | | — | | |
Certain reclassifications were made to conform the prior period consolidated financial statements to the current period presentation.
Upfront and milestone-related charges in connection with collaboration and licensing arrangements made prior to regulatory approval of a development product that were previously presented in *Research and Development* are now presented in *Acquired IPR&D* in the consolidated statements of operations.
Under ASC 830, Foreign Currency Matters (“ASC 830”), a highly inflationary economy is one that has cumulative inflation of approximately 100% or more over a three-year period.
Effective April 1, 2022, we classified Turkey as highly inflationary and began to utilize the U.S. dollar as our functional currency in Turkey, which historically utilized the Turkish lira as the functional currency.
Application of the guidance in ASC 830 did not have a material impact on our consolidated financial statements for the year ended December 31, 2022.
The impacted net sales for the year ended December 31, 2022 and total assets at December 31, 2022 represented less than 1% of our consolidated net sales and total assets, respectively.
Divestitures. For businesses that are divested, the Company records the net gain or loss on the sale within *Other (income) expense, net*.
For divestitures of businesses, including divestitures of products that qualify as a business, the Company allocates the relative fair value of goodwill associated with the businesses in the determining the gain or loss on sale.
The Company records amounts received as part of TSAs within *Other (income) expense, net.*
Receivables, including deferred consideration, with terms in excess of one year are initially recorded at their net present value using discount rates reflecting the relative credit risk.
| Net earnings (loss) attributable to Viatris Inc. common shareholders | | | $ | 2,078.6 | | | | | $ | (1,269.1) | | | | | $ | (669.9) | |
| Weighted average shares outstanding | | | 1,212.1 | | | | | | 1,208.8 | | | | | | 601.2 | | |
The Company paid quarterly dividends of $0.12 per share on the Company’s issued and outstanding common stock on March 16, 2022, June 16, 2022, September 16, 2022 and December 16, 2022.
On May 6, 2022, the Company announced that its Board of Directors had authorized a DRIP.
The DRIP allows shareholders to automatically reinvest all or a portion of the cash dividends paid on their shares of the Company’s common stock and to make certain additional optional cash investments in the Company’s common stock.
Such repurchases may be made from time-to-time at the Company’s discretion and effected by any means, including but not limited to, open market repurchases, pursuant to plans in accordance with Rules 10b5-1 or 10b-18 under the Exchange Act, privately negotiated transactions (including accelerated stock repurchase programs) or any combination of such methods as the Company deems appropriate.
The program does not have an expiration date.
During 2022, the Company did not repurchase any shares of common stock under the share repurchase program.
In January and February 2023, the Company repurchased approximately 21.2 million shares of common stock at a cost of approximately $250 million.
We adopted the ASU prospectively on January 1, 2022.
On December 21, 2022, the FASB issued ASU 2022-06 to defer the sunset date of ASC 848 until December 31, 2024.
ASU 2022-06 became effective upon issuance.
In September 2022, the FASB issued Accounting Standards Update 2022-04, *Liabilities—Supplier Finance Programs (Subtopic 405-50),* which requires entities to provide qualitative and quantitative disclosures about their supplier finance programs, including a rollforward of related obligations.
| Brands | | | 5,160.4 | | | | | | 2,190.7 | | | | | | 922.6 | | | | | | 1,615.9 | | | | | | 9,889.6 | | |
| Complex Gx and Biosimilars | | | 1,218.0 | | | | | | 0.6 | | | | | | 44.1 | | | | | | 50.7 | | | | | | 1,313.4 | | |
| Generics | | | 3,390.5 | | | | | | 9.9 | | | | | | 665.7 | | | | | | 949.0 | | | | | | 5,015.1 | | |
| Total Viatris | | | $ | 9,768.9 | | | | | $ | 2,201.2 | | | | | $ | 1,632.4 | | | | | $ | 2,615.6 | | | | | $ | 16,218.1 | |
| | | | | | |
| --- | --- | --- | --- | --- | --- |
*Critical Audit Matter Description*
*How the Critical Audit Matter Was Addressed in the Audit*
The Company has agreements with certain indirect customers, such as independent pharmacies, retail pharmacy chains, managed care organizations, hospitals, nursing homes, governmental agencies, and pharmacy benefit managers, which establish contract prices for certain products.
The indirect customers then independently select a wholesaler from which to purchase the products at these contracted prices.
Alternatively, certain wholesalers may enter into agreements with indirect customers that establish contract pricing for certain products, which the wholesalers provide.
Under either arrangement, Viatris will provide credit to the wholesaler for any difference between the contracted price with the indirect party and the wholesaler’s invoice price.
Such credits are called chargebacks.
The provision for chargebacks is the most significant and complex provision in the context of the Company’s gross-to-net adjustments in the determination of net revenue.
The chargeback accrual recorded at MPI represents the majority of the global chargeback reserve as of December 31, 2021.
The Company's recorded estimate is based on expected sell-through levels by the Company’s wholesaler customers to indirect customers, as well as estimated wholesaler inventory levels.
Estimating the amounts to be accrued for chargebacks requires significant estimation as management’s model utilizes historical buying patterns, estimated end-user demand, estimated inventory levels in the distribution channel, contracted sales terms with customers, as well as other competitive factors.
Given the volume of chargebacks and the level of estimation uncertainty involved, auditing management’s judgments required a high degree of auditor judgment and an increased extent of effort.
Our audit procedures related to the Net Revenue Provisions – Chargebacks accrual included the following, among others:
- We evaluated the Company’s methodology and assumptions in developing their chargeback accruals, including assessing the completeness and accuracy of the underlying data used by management in their estimates.
- We tested the effectiveness of controls over the calculation of the chargebacks reserves.
- We compared prior period chargebacks accruals to chargeback credits subsequently issued to evaluate management’s ability to accurately forecast chargeback activity.
- We developed independent expectations of product-level chargeback accruals and chargeback accruals in the aggregate using the 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.
Net Revenue Provisions – Sales Returns Accrual at MPI – Refer to Note 3 to the financial statements.
February 28, 2022
| Research and development | | | 751.1 | | | | | | 555.1 | | | | | | 639.9 | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Balance at December 31, 2018 | | | 539,289,665 | | | | | | $ | 6.0 | | | | | $ | 8,591.4 | | | | | $ | 6,010.7 | | | | | 23,490,867 | | | | | | $ | (999.7) | | | | | $ | (1,441.3) | | | | | | | | | | | $ | 12,167.1 | | | | |
| Issuance of restricted stock and stock options exercised, net | | | 1,457,206 | | | | | | 0.1 | | | | | | 8.1 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | | | | | | 8.2 | | | | | |
| Cancellation of restricted stock | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 1,107,207 | | | | | | — | | | | | | — | | | | | | | | | | | | — | | | | | |
| Cumulative effect of the adoption of new accounting standards | | | — | | | | | | — | | | | | | — | | | | | | 3.6 | | | | | | — | | | | | | — | | | | | | (3.6) | | | | | | | | | | | | — | | | | | |
In January 2020, the FASB issued Accounting Standards Update 2020-01, *Clarifying the Interactions Between Topic 321, Topic 323, and Topic 815* (“ASU 2020-01”)*,* which clarifies that an entity should consider observable transactions that require it to either apply or discontinue the equity method of accounting for the purposes of applying the measurement alternative in accordance with Topic 321 immediately before applying or upon discontinuing the equity method.
In addition, ASU 2020-01 states that for the purpose of applying paragraph 815-10-15-141(a) an entity should not consider whether, upon the settlement of the forward contract or exercise of the purchased option, individually or with existing investments, the underlying securities would be accounted for under the equity method in Topic 323 or the fair value option in accordance with the financial instruments guidance in Topic 825.
The Company applied the provisions of ASU 2020-01 as of January 1, 2021.
In December 2019, the FASB issued Accounting Standards Update 2019-12, *Income Taxes (Topic 740)* which is intended to simplify the accounting for income taxes by eliminating certain exceptions and simplifying certain requirements under Topic 740.
The Company applied the provisions of ASU 2019-12 on a prospective basis as of January 1, 2021.
The Company is currently assessing the impact of the adoption of this guidance on its disclosures.
| Brands | | | 4,199.1 | | | | | | 207.6 | | | | | | 533.3 | | | | | | 422.1 | | | | | | 5,362.1 | | |
| Complex Gx and Biosimilars | | | 1,127.4 | | | | | | 0.4 | | | | | | 23.8 | | | | | | 59.7 | | | | | | 1,211.3 | | |
| Generics | | | 2,913.5 | | | | | | 6.6 | | | | | | 635.4 | | | | | | 1,241.4 | | | | | | 4,796.9 | | |
| Total Viatris | | | $ | 8,240.0 | | | | | $ | 214.6 | | | | | $ | 1,192.5 | | | | | $ | 1,723.2 | | | | | $ | 11,370.3 | |
| Chargebacks | | | $ | 585.2 | | | | | $ | 5,530.1 | | | | | $ | 63.4 | | | | | $ | (5,585.4) | | | | | $ | (1.6) | | | | | $ | 591.7 | |
| Returns | | | 539.9 | | | | | | 384.6 | | | | | | 269.0 | | | | | | (499.0) | | | | | | (7.7) | | | | | | 686.8 | | |
| Governmental rebate programs | | | 313.3 | | | | | | 689.5 | | | | | | 110.6 | | | | | | (705.2) | | | | | | (9.0) | | | | | | 399.2 | | |
An excerpt. Shown here: 40 of 703 rewritten, 40 of 337 added and 40 of 339 removed. The counts are complete. For every sentence, read Item 8. Financial Statements And Supplementary Data in the FY2022 filing and the FY2021 filing.
Item 9A. Controls and Procedures
6 rewritten, 1 added, 0 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: 2021.][added: 2022.]
During the quarter ended December 31, [removed: 2021,] [added: 2022,] the Company [removed: continued to] [added: substantially completed its] transition [added: of] certain support services from Pfizer, as well as certain subsidiaries, to a new ERP system.
The Company has modified and [removed: will continue to modify its internal] [added: implemented new] controls [added: and procedures] relating to its business and financial processes throughout the transition [removed: period, which is expected through the end of calendar year 2022.][added: period.]
While the Company believes that this new system and the related changes to internal controls will ultimately strengthen its [removed: internal control over financial reporting,] [added: ICFR,] there are inherent risks in implementing any new ERP system and the Company [removed: has evaluated and tested control changes in order] [added: will continue] to [removed: provide Management’s Report on Internal Control over Financial Reporting for] [added: evaluate and monitor] the [removed: year ended December 31, 2021.][added: effectiveness of the related controls in subsequent periods.]
Management’s Report on Internal Control over Financial Reporting is on page [removed: 79,] [added: 76,] which is incorporated herein by reference.
The effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2021] [added: 2022] has been audited by Deloitte & Touche LLP (PCAOB ID No. 34), an independent registered public accounting firm, as stated in their report on page [removed: 83,] [added: 80,] which is incorporated herein by reference.
Management identified the following change in the Company’s internal control over financial reporting (“ICFR”) that occurred during the quarter that has materially affected, or is reasonably likely to materially affect, the Company’s ICFR.
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: 2021:][added: 2022:]
| Equity compensation plans approved by security holders | | | 31,721,568 | | | | | | $ | 15.56 | | | | | 43,297,637 | | |
| Total | | | 31,721,568 | | | | | | $ | 15.56 | | | | | 43,297,637 | | |
| Equity compensation plans approved by security holders | | | 22,434,618 | | | | | | $ | 20.60 | | | | | 59,591,643 | | |
| Total | | | 22,434,618 | | | | | | $ | 20.60 | | | | | 59,591,643 | | |
Item 15. Exhibits, Consolidated Financial Statement Schedules
51 rewritten, 6 added, 14 removed, 152 unchanged
| [removed: [4.3(a)](http://www.sec.gov/Archives/edgar/data/1623613/000119312515403822/d73153dex41.htm)] [added: [4.3(a)](http://www.sec.gov/Archives/edgar/data/1623613/000119312516622620/d207286dex41.htm)] | | | | | | Indenture, dated as of [removed: December] [added: June] 9, [removed: 2015,] [added: 2016,] among Mylan N.V., as issuer, Mylan Inc., as guarantor, and The Bank of New York Mellon, as trustee, filed as Exhibit 4.1 to the Report on Form 8-K filed by Mylan N.V. with the SEC on [removed: December] [added: June] 15, [removed: 2015,] [added: 2016,] and incorporated herein by reference. | | |
| [removed: [4.3(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex43.htm)] [added: [4.3(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex44.htm)] | | | | | | First Supplemental Indenture dated November 16, 2020, by and among Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V., Mylan Inc. and the Bank of New York Mellon, as trustee, to the Indenture dated [removed: December] [added: June] 9, [removed: 2015,] [added: 2016,] by and among Mylan N.V., Mylan Inc. and the Bank of New York Mellon, as trustee, filed as Exhibit [removed: 4.3] [added: 4.4] 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: [4.4(a)](http://www.sec.gov/Archives/edgar/data/1623613/000119312516622620/d207286dex41.htm)] [added: [4.5(a)](http://www.sec.gov/Archives/edgar/data/1623613/000119312518111603/d560332dex41.htm)] | | | | | | Indenture, dated as of [removed: June] [added: April] 9, [removed: 2016,] [added: 2018,] among Mylan [removed: N.V.,] [added: Inc.,] as issuer, Mylan [removed: Inc.,] [added: N.V.,] as guarantor, and [removed: The] [added: the] Bank of New York Mellon, as trustee, filed as Exhibit 4.1 to the Report on Form 8-K filed by Mylan N.V. with the SEC on [removed: June 15, 2016,] [added: April 9, 2018,] and incorporated herein by reference. | | |
| [removed: [4.4(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex44.htm)] [added: [4.7(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex41.htm)] | | | | | | First Supplemental Indenture dated November 16, 2020, by and among Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V., Mylan Inc. and the Bank of New York Mellon, as trustee, to the Indenture dated June [removed: 9, 2016,] [added: 22, 2020,] by and among [removed: Mylan N.V., Mylan] [added: Viatris] Inc. and the Bank of New York Mellon, as trustee, filed as Exhibit [removed: 4.4] [added: 4.1] 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: [4.5(a)](http://www.sec.gov/Archives/edgar/data/1623613/000162361317000007/exhibit49.htm)] [added: [4.4(a)](http://www.sec.gov/Archives/edgar/data/1623613/000162361317000007/exhibit49.htm)] | | | | | | Indenture, dated November 22, 2016, among Mylan N.V., as issuer, Mylan, Inc., as guarantor and Citibank, N.A., London Branch, as trustee, paying agent, transfer agent, registrar and calculation agent, filed by Mylan N.V. as Exhibit 4.9 to Form 10-K for the fiscal year ended December 31, 2016, and incorporated herein by reference. | | |
| [removed: [4.5(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex45.htm)] [added: [4.4(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex45.htm)] | | | | | | First Supplemental Indenture dated November 16, 2020, by and among Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V., Mylan Inc. and Citibank, N.A., London Branch, as trustee, paying agent, transfer agent, and registrar, to the Indenture dated November 22, 2016, by and among Mylan N.V., Mylan Inc. and Citibank, N.A., London Branch, as trustee, paying agent, transfer agent, registrar and calculation agent, filed as Exhibit 4.5 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: [4.6(a)](http://www.sec.gov/Archives/edgar/data/1623613/000119312518111603/d560332dex41.htm)] [added: [4.6(a)](http://www.sec.gov/Archives/edgar/data/1623613/000119312518172116/d566535dex41.htm)] | | | | | | Indenture, dated as of [removed: April 9,] [added: May 23,] 2018, among Mylan Inc., as issuer, Mylan N.V., as guarantor, and [removed: the Bank of New York Mellon,] [added: Citibank, N.A., London Branch,] as trustee, [added: paying agent, transfer agent and registrar,] filed as Exhibit 4.1 to the Report on Form 8-K filed by Mylan N.V. with the SEC on [removed: April 9,] [added: May 23,] 2018, and incorporated herein by reference. | | |
| [removed: [4.6(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex48.htm)] [added: [4.5(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex48.htm)] | | | | | | First Supplemental Indenture dated November 16, 2020, by and among Mylan Inc., Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V. and the Bank of New York Mellon, as trustee, to the Indenture dated April 9, 2018, by and among Mylan Inc., Mylan N.V. and the Bank of New York Mellon, as trustee, filed as Exhibit 4.8 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: [4.7(a)](http://www.sec.gov/Archives/edgar/data/1623613/000119312518172116/d566535dex41.htm)] [added: [4.8(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520181088/d920857dex49.htm)] | | | | | | Indenture, dated as of [removed: May] [added: June] 23, [removed: 2018,] [added: 2020,] among [removed: Mylan Inc.,] [added: Upjohn Finance B.V.,] as issuer, [removed: Mylan N.V.,] [added: Upjohn Inc.,] as guarantor, and Citibank, N.A., London Branch, as trustee, [removed: paying agent,] transfer [added: agent, paying] agent and registrar, filed as Exhibit [removed: 4.1] [added: 4.9] to the Report on Form 8-K filed by [removed: Mylan N.V.] [added: Upjohn Inc.] with the SEC on [removed: May 23, 2018,] [added: June 26, 2020,] and incorporated herein by reference. | | |
| [removed: [4.7(b)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex49.htm)] [added: [4.6(b)](https://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex49.htm)] | | | | | | First Supplemental Indenture dated November 16, 2020, by and among Mylan Inc., Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V. and Citibank, N.A., London Branch, as trustee, paying agent, transfer agent, and registrar, to the Indenture dated May 23, 2018, by and among Mylan Inc., Mylan N.V. and Citibank, N.A., London Branch, as trustee, paying agent, transfer agent, and registrar, filed as Exhibit 4.9 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: [4.8(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520181088/d920857dex41.htm)] [added: [4.7(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520181088/d920857dex41.htm)] | | | | | | Indenture, dated as of June 22, 2020, between Upjohn Inc., as issuer, and The Bank of New York Mellon, as trustee, filed as Exhibit 4.1 to the Report on Form 8-K filed by Upjohn Inc. with the SEC on June 26, 2020, and incorporated herein by reference. | | |
| [removed: [4.8(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex41.htm)] [added: [4.8(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex42.htm)] | | | | | | First Supplemental Indenture dated November 16, 2020, by and among [added: Upjohn Finance B.V.,] Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V., Mylan Inc. and [removed: the Bank of New York Mellon,] [added: Citibank, N.A., London Branch,] as trustee, [added: paying agent, transfer agent, and registrar,] to the Indenture dated June [removed: 22,] [added: 23,] 2020, by and among [added: Upjohn Finance B.V.,] Viatris Inc. and [removed: the Bank of New York Mellon,] [added: Citibank, N.A., London Branch,] as trustee, [added: paying agent, transfer agent, and registrar,] filed as Exhibit [removed: 4.1] [added: 4.2] 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: [4.9(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520181088/d920857dex49.htm)] [added: [10.25(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520170586/d133688dex101.htm)] | | | | | | [removed: Indenture,] [added: Revolving Credit Agreement,] dated as of June [removed: 23,] [added: 16,] 2020, among Upjohn [removed: Finance B.V., as issuer, Upjohn] Inc., [removed: as guarantor,] [added: the guarantors from time to time party thereto, the lenders] and [removed: Citibank,] [added: issuing banks from time to time party thereto and Bank of America,] N.A., [removed: London Branch,] as [removed: trustee, transfer] [added: administrative] agent, [removed: paying agent and registrar,] filed as Exhibit [removed: 4.9] [added: 10.1] to the Report on Form 8-K filed by Upjohn Inc. with the SEC on June [removed: 26,] [added: 17,] 2020, and incorporated herein by reference. | | |
| [removed: [4.9(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex42.htm)] [added: [10.28](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex101.htm)] | | | | | | [removed: First Supplemental Indenture dated November 16, 2020, by and] [added: Form of Dealer Agreement] among [removed: Upjohn Finance B.V.,] Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V., Mylan Inc. and [removed: Citibank, N.A., London Branch, as trustee, paying agent, transfer agent, and registrar, to] the [removed: Indenture dated June 23, 2020, by and among Upjohn Finance B.V., Viatris Inc. and Citibank, N.A., London Branch, as trustee, paying agent, transfer agent, and registrar,] [added: dealer thereto,] filed as Exhibit [removed: 4.2] [added: 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: [4.10](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_410-vtrsx20201231x10k.htm)] [added: [4.9](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 Act, filed as Exhibit 4.10 to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference. | | |
| [removed: [10.10(h)](http://www.sec.gov/Archives/edgar/data/1623613/000162361318000019/myl_ex102x20180331-10q.htm)] [added: [10.10(j)](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: 21, 2018,] [added: 19, 2019,] filed by Mylan N.V. as Exhibit [removed: 10.2] [added: 10.6] to Form 10-Q for the quarter ended March 31, [removed: 2018,] [added: 2019,] and incorporated herein by reference.* | | |
| [removed: [10.10(i)](http://www.sec.gov/Archives/edgar/data/1623613/000162361318000019/myl_ex103x20180331-10q.htm)] [added: [10.10(i)](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(j)](http://www.sec.gov/Archives/edgar/data/1623613/000162361319000016/myl_ex107x20190331-10xq.htm)] [added: [10.10(h)](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(k)](http://www.sec.gov/Archives/edgar/data/1623613/000162361319000016/myl_ex108x20190331-10q.htm)] [added: [10.10(k)](http://www.sec.gov/Archives/edgar/data/1623613/000162361320000018/mylex10220200331-10q.htm)] | | | | | | Form of [removed: 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: 10.8] [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/mylex10220200331-10q.htm)] [added: [10.32(a)](http://www.sec.gov/Archives/edgar/data/1623613/000162361320000035/ex102myl10-q09302020.htm)] | | | | | | [removed: Form] [added: Asset Purchase Agreement, dated as] of [removed: Stock Option Agreement under the Mylan N.V. 2003 Long-Term Incentive Plan for independent directors for awards granted on or after March 2,] [added: September 7,] 2020, [added: between Aspen Global Incorporated and Mylan Ireland Limited,] filed by Mylan N.V. as Exhibit 10.2 to [added: the] Form 10-Q for the quarter ended [removed: March 31,] [added: September 30,] 2020, and incorporated herein by [removed: reference.*] [added: reference.^] | | |
| [removed: [10.19](http://www.sec.gov/Archives/edgar/data/1623613/000162361320000018/mylex10320200331-10q.htm)] [added: [10.19](http://www.sec.gov/Archives/edgar/data/1623613/000162361319000008/myl_ex1020cx20181231-10xk.htm)] | | | | | | [added: Third Amended and Restated] Executive Employment Agreement, entered into on [added: February 25, 2019, and effective as of] April [removed: 15, 2020,] [added: 1, 2019,] by and between Mylan [removed: N.V., Mylan] Inc. and [removed: Robert J. Coury,] [added: Rajiv Malik,] filed by Mylan N.V. as Exhibit [removed: 10.3] [added: 10.20(c)] to Form [removed: 10-Q] [added: 10-K] for the [removed: quarter] [added: fiscal year] ended [removed: March] [added: December] 31, [removed: 2020,] [added: 2018,] and incorporated herein by reference.* | | |
| [removed: [10.20](http://www.sec.gov/Archives/edgar/data/1623613/000162361319000008/myl_ex1020cx20181231-10xk.htm)] [added: [10.20](http://www.sec.gov/Archives/edgar/data/1623613/000162361319000008/myl_ex1021bx20181231-10xk.htm)] | | | | | | [removed: Third Amended and Restated] Executive Employment Agreement, [removed: entered into on] [added: dated as of] February 25, 2019, and effective as of April 1, 2019, by and between Mylan Inc. and [removed: Rajiv Malik,] [added: Anthony Mauro,] filed [removed: by Mylan N.V.] as Exhibit [removed: 10.20(c)] [added: 10.21(b)] to Form 10-K for the fiscal year ended December 31, 2018, and incorporated herein by reference.* | | |
| [removed: [10.21](http://www.sec.gov/Archives/edgar/data/1623613/000162361319000008/myl_ex1021bx20181231-10xk.htm)] [added: [10.23](http://www.sec.gov/Archives/edgar/data/69499/000006949914000007/myl_ex1038x20131231-10k.htm)] | | | | | | [removed: Executive Employment Agreement, dated as of February 25, 2019,] [added: Amended] and [removed: effective as] [added: Restated Form] of [removed: April 1, 2019, by and] [added: Indemnification Agreement] between Mylan Inc. and [removed: Anthony Mauro,] [added: each Director,] filed [added: by Mylan Inc.] as Exhibit [removed: 10.21(b)] [added: 10.38] to Form 10-K for the fiscal year ended December 31, [removed: 2018,] [added: 2013,] and incorporated herein by reference.* | | |
| [removed: [10.23](http://www.sec.gov/Archives/edgar/data/1623613/000162361317000014/exhibit104_20170331.htm)] [added: [10.24](http://www.sec.gov/Archives/edgar/data/1623613/000119312515068819/d882101dex101.htm)] | | | | | | Form of [removed: Waiver Letter with respect to Specified Award Agreements by and] [added: Indemnification Agreement] between Mylan N.V. and [removed: Rajiv Malik, February 23, 2017,] [added: directors,] filed [removed: by Mylan N.V.] as Exhibit [removed: 10.4] [added: 10.1] to [added: the Report on] Form [removed: 10-Q for] [added: 8-K filed by Mylan N.V. with] the [removed: quarter ended March 31, 2017,] [added: SEC on February 27, 2015,] and incorporated herein by [removed: reference. *] [added: reference.*] | | |
| [removed: [10.24](http://www.sec.gov/Archives/edgar/data/1623613/000162361320000011/mylex102920191231-10k.htm)] [added: [10.21](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 10.29 to the Form 10-K for the fiscal year ended December 31, 2019 and incorporated herein by reference.* | | |
| [removed: [10.25](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_1025-vtrsx20201231x10xk.htm)] [added: [10.22](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 officers, filed as Exhibit 10.25 to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference.* | | |
| [removed: [10.27](http://www.sec.gov/Archives/edgar/data/1623613/000119312515068819/d882101dex101.htm)] [added: [10.29](http://www.sec.gov/Archives/edgar/data/1623613/000119312517263762/d418144dex101.htm)] | | | | | | [removed: Form of Indemnification] [added: Settlement] Agreement [removed: between Mylan N.V.] [added: with the U.S. Department of Justice] and [removed: directors,] [added: 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 [removed: February 27, 2015,] [added: August 21, 2017,] and incorporated herein by [removed: reference.*] [added: reference.] | | |
| [removed: [10.28(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312520170586/d133688dex101.htm)] [added: [10.25(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312521206477/d50384dex101.htm)] | | | | | | [added: Amended and Restated] Revolving Credit Agreement, dated as of [removed: June 16, 2020,] [added: July 1, 2021,] among [removed: Upjohn Inc.,] [added: 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 [removed: Upjohn] [added: Viatris] Inc. with the SEC on [removed: June 17, 2020,] [added: July 1, 2021,] and incorporated herein by reference. [added: ^] | | |
| [removed: [10.28(b)](http://www.sec.gov/Archives/edgar/data/1792044/000119312521206477/d50384dex101.htm)] [added: [10.27](http://www.sec.gov/Archives/edgar/data/1792044/000119312521206477/d50384dex102.htm)] | | | | | | [removed: Amended and Restated Revolving] [added: Term Loan] Credit Agreement, dated as of July 1, 2021, among Viatris, the guarantors from time to time party thereto, the lenders [removed: and issuing banks] from time to time party thereto and [removed: Bank of America, N.A.,] [added: Mizuho Bank, Ltd.,] as administrative agent, filed as Exhibit [removed: 10.1] [added: 10.2] to the Report on Form 8-K filed by Viatris Inc. with the SEC on July 1, 2021, and incorporated herein by reference. ^ | | |
| [removed: [10.29](http://www.sec.gov/Archives/edgar/data/1792044/000119312520170586/d133688dex102.htm)] [added: [10.26](http://www.sec.gov/Archives/edgar/data/1792044/000119312520170586/d133688dex102.htm)] | | | | | | Delayed Draw Term Loan Credit Agreement, dated as of June 16, 2020, among Upjohn Inc., the guarantors from time to time party thereto, the lenders from time to time party thereto and MUFG Bank, Ltd., as administrative agent, filed as Exhibit 10.2 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/1792044/000119312521206477/d50384dex102.htm)] [added: [2.3(a)](http://www.sec.gov/Archives/edgar/data/1792044/000119312522058054/d265304dex21.htm)] | | | | | | [removed: Term Loan Credit] [added: Transaction] Agreement, dated as of [removed: July 1, 2021,] [added: February 27, 2022, by and] among [removed: Viatris, the guarantors from time to time party thereto, the lenders from time to time party thereto] [added: Biocon Biologics Limited] and [removed: Mizuho Bank, Ltd., as administrative agent,] [added: Viatris Inc.,] filed as Exhibit [removed: 10.2] [added: 2.1] to the Report on Form 8-K filed by Viatris Inc. with the SEC on [removed: July 1, 2021,] [added: February 28, 2022,] and incorporated herein by [removed: reference. ^] [added: reference.^] | | |
| [removed: [10.31](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298236/d57281dex101.htm)] [added: [10.36](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex104.htm)] | | | | | | [removed: Form] [added: Employee Matters Agreement, dated as] of [removed: Dealer Agreement among Viatris Inc., Utah Acquisition Sub Inc., Mylan II B.V., Mylan] [added: November 16, 2020, by and between Pfizer] Inc. and [removed: the dealer thereto,] [added: Viatris Inc.,] filed as Exhibit [removed: 10.1] [added: 10.4] to the Report on Form [removed: 8-K/A] [added: 8-K] filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by [removed: reference.] [added: reference.^] | | |
| [removed: [10.32](http://www.sec.gov/Archives/edgar/data/1623613/000119312517263762/d418144dex101.htm)] [added: [10.30](http://www.sec.gov/Archives/edgar/data/1623613/000119312517263762/d418144dex102.htm)] | | | | | | [removed: Settlement] [added: Corporate Integrity] Agreement [removed: with] [added: between] the [removed: U.S.] [added: Office of Inspector General of the] Department of [removed: Justice] [added: Health] and [removed: two relators finalizing the Medicaid drug rebate settlement,] [added: Human Services and Mylan Inc. and Mylan Specialty L.P.,] dated August 16, 2017, filed as Exhibit [removed: 10.1] [added: 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/1623613/000119312517263762/d418144dex102.htm)] [added: [10.33](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex101.htm)] | | | | | | [removed: Corporate Integrity Agreement between the Office of Inspector General of the Department of Health and Human] [added: Transition] Services [added: Agreement, dated as of November 16, 2020, by] and [removed: Mylan] [added: between Pfizer] Inc. [added: (as Service Provider)] and [removed: Mylan Specialty L.P., dated August 16, 2017,] [added: Upjohn Inc. (as Service Recipient),] filed as Exhibit [removed: 10.2] [added: 10.1] to the Report on Form 8-K filed by [removed: Mylan N.V.] [added: Viatris Inc.] with the SEC on [removed: August 21, 2017,] [added: November 19, 2020,] and incorporated herein by reference. [added: ^] | | |
| [removed: [10.34](http://www.sec.gov/Archives/edgar/data/1792044/000119312520181088/d920857dex48.htm)] [added: [10.31](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: [10.35(a)](http://www.sec.gov/Archives/edgar/data/1623613/000162361320000035/ex102myl10-q09302020.htm)] [added: [10.32(b)](http://www.sec.gov/Archives/edgar/data/1792044/000179204421000009/ex_1034b-vtrsx20201231x10xk.htm)] | | | | | | [added: Amendment No. 1, dated as of November 5, 2020, to the] Asset Purchase [removed: Agreement,] [added: Agreement] dated as of September 7, 2020, between Aspen Global Incorporated and Mylan Ireland Limited, filed [removed: by Mylan N.V.] as Exhibit [removed: 10.2] [added: 10.34(b)] to [removed: the] Form [removed: 10-Q] [added: 10-K] for the [removed: quarter] [added: fiscal year] ended [removed: September 30,] [added: December 31,] 2020, and incorporated herein by [removed: reference.^] [added: reference. ^] | | |
| [removed: [10.36](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex101.htm)] [added: [10.34](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex102.htm)] | | | | | | Transition Services Agreement, dated as of November 16, 2020, by and between [removed: Pfizer] [added: Upjohn] Inc. (as Service Provider) and [removed: Upjohn] [added: Pfizer] Inc. (as Service Recipient), filed as Exhibit [removed: 10.1] [added: 10.2] to the Report on Form 8-K filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. ^ | | |
| [removed: [10.37](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex102.htm)] [added: [10.35](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex103.htm)] | | | | | | [removed: Transition Services] [added: Tax Matters] Agreement, dated as of November 16, 2020, by and between [removed: Upjohn Inc. (as Service Provider) and] Pfizer Inc. [removed: (as Service Recipient),] [added: and Upjohn Inc.,] filed as Exhibit [removed: 10.2] [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: [10.38](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex103.htm)] [added: [10.39](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex107.htm)] | | | | | | [removed: Tax] [added: Intellectual Property] Matters Agreement, dated as of November 16, 2020, by and between Pfizer Inc. and [removed: Upjohn] [added: Viatris] Inc., filed as Exhibit [removed: 10.3] [added: 10.7] to the Report on Form 8-K filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. ^ | | |
| [removed: [10.39](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex104.htm)] [added: [10.40](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex108.htm)] | | | | | | [removed: Employee Matters] [added: Trademark License] Agreement, dated as of November 16, 2020, by and between Pfizer Inc. and Viatris Inc., filed as Exhibit [removed: 10.4] [added: 10.8] to the Report on Form 8-K filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by [removed: reference.^] [added: reference. ^] | | |
| Year ended December 31, 2022 | | | $ | 154.5 | | | | | 21.5 | | | | | | — | | | | | | (61.3) | | | | | | $ | 114.7 | |
| Year ended December 31, 2022 | | | $ | 780.4 | | | | | 42.7 | | | | | | — | | | | | | (436.1) | | | | | | $ | 387.0 | |
| /s/ ELISHA FINNEY | | | | | | Director | | |
| Elisha Finney | | | | | | | | |
| /s/ SCOTT SMITH | | | | | | Director | | |
| Scott Smith | | | | | | | | |
| Year ended December 31, 2019 | | | $ | 98.2 | | | | | 14.2 | | | | | | — | | | | | | (39.6) | | | | | | $ | 72.8 | |
| Year ended December 31, 2019 | | | $ | 806.0 | | | | | 36.8 | | | | | | — | | | | | | (239.3) | | | | | | $ | 603.5 | |
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| [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 19, 2019, filed by Mylan N.V. as Exhibit 10.6 to Form 10-Q for the quarter ended March 31, 2019, and incorporated herein by reference.* | | |
| [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 independent directors for awards granted on or after March 2, 2020, filed by Mylan N.V. as Exhibit 10.1 to Form 10-Q for the quarter ended March 31, 2020, and incorporated herein by reference.* | | |
| [10.22](http://www.sec.gov/Archives/edgar/data/1623613/000162361316000065/myl_ex105x20160630-10q.htm) | | | | | | Letter Agreement, dated June 3, 2016, among Mylan N.V., Mylan Inc., and Robert J. Coury, filed by Mylan N.V. as Exhibit 10.5 to Form 10-Q for the quarter ended June 30, 2016, and incorporated herein by reference.* | | |
| [10.26](http://www.sec.gov/Archives/edgar/data/69499/000006949914000007/myl_ex1038x20131231-10k.htm) | | | | | | Amended and Restated Form of Indemnification Agreement between Mylan Inc. and each Director, filed by Mylan Inc. as Exhibit 10.38 to Form 10-K for the fiscal year ended December 31, 2013, and incorporated herein by reference.* | | |
| [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 Limited, filed as Exhibit 10.34(b) to Form 10-K for the fiscal year ended December 31, 2020, and incorporated herein by reference. ^ | | |
| [10.43](http://www.sec.gov/Archives/edgar/data/1792044/000119312520298226/d56774dex108.htm) | | | | | | Trademark License Agreement, dated as of November 16, 2020, by and between Pfizer Inc. and Viatris Inc., filed as Exhibit 10.8 to the Report on Form 8-K filed by Viatris Inc. with the SEC on November 19, 2020, and incorporated herein by reference. ^ | | |
| /s/ NEIL DIMICK | | | | | | Director | | |
| Neil Dimick | | | | | | | | |
| /s/ IAN READ | | | | | | Director | | |
| Ian Read | | | | | | | | |
An excerpt. Shown here: 40 of 51 rewritten, all 6 added and all 14 removed. The counts are complete. For every sentence, read Item 15. Exhibits, Consolidated Financial Statement Schedules in the FY2022 filing and the FY2021 filing.