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2026-08-07 01:02 1mo ago
2026-08-06 19:44 1mo ago
Viatris komentuje finanční guidance na rok 2026 a strategické iniciativy
VTRS Viatris
FMP Stock News 78
Original source text
Viatris Inc. (VTRS) Q2 2026 Earnings Call August 6, 2026 8:30 AM EDT

Company Participants

William Szablewski - Head of Investor Relations & Capital Markets
Scott Smith - CEO & Director
Philippe Martin - Chief R&D Officer
Paul Campbell - Interim CFO, Chief Accounting Officer & Corporate Controller
Corinne Le Goff - Chief Commercial Officer

Conference Call Participants

Ashwani Verma - UBS Investment Bank, Research Division
Umer Raffat - Evercore ISI Institutional Equities, Research Division
Matthew Dellatorre - Goldman Sachs Group, Inc., Research Division
Glen Santangelo - Barclays Bank PLC, Research Division
Ethan Brown - JPMorgan Chase & Co, Research Division
Yuchen Ding - Jefferies LLC, Research Division
Jason Gerberry - BofA Securities, Research Division
David Amsellem - Piper Sandler & Co., Research Division

Presentation

Operator

Good morning, everyone, and welcome to the Viatris Q2 2026 Earnings Call. [Operator Instructions] Please also note today's event is being recorded.

At this time, I'd like to turn the floor over to Bill Szablewski, Head of Capital Markets. Sir, please go ahead.

William Szablewski
Head of Investor Relations & Capital Markets

Good morning, everyone. Welcome to our Q2 2026 earnings call. With us today is CEO, Scott Smith; Interim CFO, Paul Campbell; Chief R&D Officer, Philippe Martin; and Chief Commercial Officer, Corinne Le Goff.

During today's call, we will be making forward-looking statements on a number of matters, including our financial guidance for 2026 and various strategic initiatives. These statements are subject to risks and uncertainties.

We will also be referring to certain actual and projected non-GAAP financial measures. Please refer to today's slide presentation and our SEC filings for more information, including reconciliations of those non-GAAP measures to most directly comparable GAAP measures.

When discussing 2026 actual or reported results, we will be making certain comparisons to 2025 actual or reported results on an operational basis, which excludes the impact of foreign currency
2026-08-06 20:13 1mo ago
2026-08-06 13:56 1mo ago
Viatris prodá Tyrvayu a zvýšila výhled pro fiskální rok 2026
VTRS Viatris
FMP Stock News 78
Original source text
Harrow Inc. (NASDAQ:HROW) on Thursday agreed to acquire Tyrvaya (varenicline solution) nasal spray 0.03 mg from Viatris Inc. (NASDAQ:VTRS).

Viatris To Sell Tyrvaya To Harrow In Up To $100 Million DealTyrvaya is a cholinergic agonist indicated for signs and symptoms of dry eye disease and is currently approved in the U.S., China, and Taiwan, with marketing authorization applications pending in other countries.

Harrow will pay $30 million in cash and up to $70 million in contingent milestone payments tied to Tyrvaya’s net sales, for a potential total consideration of up to $100 million.

The transaction is expected to close in the second half of 2026.

Read Next

Viatris Q2 PerformanceViatris on Thursday reported second-quarter adjusted earnings of 69 cents per share, beating the consensus of 60 cents.

The generic drug maker reported sales of $3.756 billion, ahead of the consensus of $3.675 billion.

Sales jumped 5% year over year (+3.5% on an operational basis), primarily driven by new product sales in Developed Markets and strong growth in Greater China.

“Our second-quarter results reflect another quarter of strong execution and reinforce the momentum we’re building across our business,” said Scott A. Smith, CEO, Viatris. “Commercial execution, pipeline progress and the early benefits of our enterprise-wide strategic review continue strengthening our business and improving our financial performance.”

In the company earnings conference call, Viatris said the Tyrvaya deal will help it focus on high-potential growth areas, particularly in complex generics and transdermal products, as well as continued investment in the Greater China market.

Viatris Raises 2026 Earnings And Sales Guidance“Our strong first-half results give us the confidence to raise our full-year guidance. We expect a more balanced operating environment in the second half of the year, and we remain focused on disciplined execution, investing behind our future growth drivers and creating long-term value for patients and shareholders,” Smith said.

Viatris raised its fiscal 2026 adjusted earnings guidance from $2.33-$2.47 per share to $2.45-$2.49 compared to the consensus of $2.44.

The company raised its 2026 sales guidance from $14.45 billion-$14.95 billion to $14.55 billion-$14.95 billion versus the Wall Street estimate of $14.783 billion.

VTRS Price Action: Viatris shares were down 4.16% at $16.91 at the time of publication on Thursday, according to Benzinga Pro data.

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2026-08-06 12:59 1mo ago
2026-08-06 06:59 1mo ago
Viatris zvýšil tržby, upravený EBITDA i výhled pro rok 2026
VTRS Viatris
FMP Stock News 92
Original source text
Delivers Total Revenues of $3.8 Billion, Representing 5% Reported Growth Compared to Second Quarter 2025 and a U.S. GAAP Net Loss of $119 Million Total Revenues Were Up 3.5% Operationally Compared to Second Quarter 2025 Adjusted EBITDA was $1.2 Billion, Up 8% Operationally Compared to Second Quarter 2025 Advances Key Pipeline Milestones, Including U.S. FDA Approval of Gwyn LoTM Announces Sale of Global Rights to Tyrvaya® Returns Approximately $550 Million of Capital to Shareholders, Including Through Share Repurchases; Reduces Gross Leverage Ratio to 2.9x Raises 2026 Financial Guidance Midpoints for All Metrics [1] , /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced its second-quarter 2026 financial results.

Executive Commentary

"Our second-quarter results reflect another quarter of strong execution and reinforce the momentum we're building across our business," said Scott A. Smith, CEO, Viatris. "Commercial execution, pipeline progress and the early benefits of our enterprise-wide strategic review continue strengthening our business and improving our financial performance. Our strong first-half results give us the confidence to raise our full-year guidance. We expect a more balanced operating environment in the second half of the year and we remain focused on disciplined execution, investing behind our future growth drivers and creating long-term value for patients and shareholders."

"We delivered another strong quarter of Total Revenues and Adjusted EBITDA growth over the prior year, reflecting continued strong operational execution," said Paul Campbell, Interim CFO, Chief Accounting Officer & Corporate Controller, Viatris. "At the same time, we continued to execute on our balanced capital allocation strategy, returning approximately $550 million to shareholders, including approximately $270 million of share repurchases occurring through early August. In addition, we further strengthened our balance sheet and reduced our gross leverage ratio to 2.9x."

[1] Viatris is not providing forward-looking guidance for U.S. GAAP net earnings (loss) or U.S. GAAP diluted EPS (loss) or a quantitative reconciliation of its 2026 Adjusted EBITDA or Adjusted EPS guidance. U.S. GAAP net cash provided by operating activities for 2026 is estimated to be between $1.9 billion and $2.1 billion, with a midpoint of approximately $2.0 billion. 2026 financial guidance ranges as provided on August 6, 2026, exclude the impact of any transaction-related and restructuring-related costs (as defined below) and acquired IPR&D for unsigned deals as they cannot be reasonably forecasted. Please see "2026 Financial Guidance" and "Non-GAAP Financial Measures" for additional information.

Second-Quarter Results

Three Months Ended

June 30,

(Unaudited; in millions, except %s and per share amounts)

2026

2025

Reported
Change

Operational
Change(1) (2)

Total Revenues

$ 3,756.8

$ 3,582.1

5 %

4 %

Total Net Sales

$ 3,745.9

$ 3,569.0

5 %

4 %

Developed Markets

2,193.7

2,119.3

4 %

2 %

Emerging Markets

542.3

555.1

(2) %

(2) %

JANZ

296.1

305.7

(3) %

— %

Greater China

713.8

588.9

21 %

16 %

Net Sales by Product Category

Brands

$ 2,418.4

$ 2,284.5

6 %

4 %

Generics

1,327.5

1,284.5

3 %

3 %

U.S. GAAP Gross Profit

$ 1,456.5

$ 1,332.9

9 %

U.S. GAAP Gross Margin

38.8 %

37.2 %

Adjusted Gross Profit (2)

$ 2,158.9

$ 2,028.4

6 %

Adjusted Gross Margin (2)

57.5 %

56.6 %

U.S. GAAP Net Loss

$   (118.8)

$       (4.6)

NM

U.S. GAAP Loss Per Share

$     (0.10)

$         —

NM

Adjusted Net Earnings (2)

$    808.5

$    726.0

11 %

Adjusted EPS (2)

$      0.69

$      0.62

11 %

9 %

EBITDA (2)

$    729.0

$    577.8

26 %

Adjusted EBITDA (2)

$ 1,188.3

$ 1,078.8

10 %

8 %

U.S. GAAP Net Cash Provided by Operating Activities

$    381.8

$    219.7

74 %

Capital Expenditures

52.8

52.9

— %

Free Cash Flow (2)(3)

$    329.0

$    166.8

97 %

___________

(1)

See "Certain Key Terms and Presentation Matters" in this release for more information.

(2)

Non-GAAP financial measures. See "Non-GAAP Financial Measures" for additional information.

(3)

Excluding the impact of transaction-related and restructuring-related costs of $120 million, free cash flow for the three months ended June 30, 2026, was $449 million. Excluding the impact of transaction-related costs of $74 million, free cash flow for the three months ended June 30, 2025, was $241 million.

Six Months Ended

June 30,

(Unaudited; in millions, except %s and per share amounts)

2026

2025

Reported
Change

Operational
Change(1) (2)

Total Revenues

$  7,273.8

$  6,836.4

6 %

3 %

Total Net Sales

$  7,255.6

$  6,812.2

7 %

3 %

Developed Markets

4,214.5

4,011.0

5 %

1 %

Emerging Markets

1,077.7

1,075.0

— %

(1) %

JANZ

569.5

581.8

(2) %

(1) %

Greater China

1,393.9

1,144.4

22 %

17 %

Net Sales by Product Category

Brands

$  4,750.9

$  4,401.4

8 %

4 %

Generics

2,504.7

2,410.8

4 %

2 %

U.S. GAAP Gross Profit

$  2,613.7

$  2,494.1

5 %

U.S. GAAP Gross Margin

35.9 %

36.5 %

Adjusted Gross Profit (2)

$  4,129.2

$  3,848.0

7 %

Adjusted Gross Margin (2)

56.8 %

56.3 %

U.S. GAAP Net Earnings (Loss) (3)

$       57.6

$ (3,046.6)

NM

U.S. GAAP Earnings (Loss) Per Share (3)

$       0.05

$      (2.58)

NM

Adjusted Net Earnings (2)

$  1,502.6

$  1,326.3

13 %

Adjusted EPS (2)

$       1.28

$       1.11

15 %

11 %

EBITDA (2)

$  1,277.9

$ (1,739.0)

NM

Adjusted EBITDA (2)

$  2,237.8

$  2,002.3

12 %

9 %

U.S. GAAP Net Cash Provided by Operating Activities

$     770.1

$     755.2

2 %

Capital Expenditures

92.7

95.5

(3) %

Free Cash Flow (2)(4)

$     677.4

$     659.7

3 %

___________

(1)

See "Certain Key Terms and Presentation Matters" in this release for more information.

(2)

Non-GAAP financial measures. See "Non-GAAP Financial Measures" for additional information.

(3)

For the six months ended June 30, 2025, includes the previously disclosed goodwill impairment charge of $2.9 billion as a result of the interim goodwill impairment test performed as of March 31, 2025.

(4)

Excluding the impact of transaction-related and restructuring-related costs of $231 million, free cash flow for the six months ended June 30, 2026, was $908 million. Excluding the impact of transaction-related costs of $116 million, free cash flow for the six months ended June 30, 2025, was $776 million.

Financial Highlights for the Second Quarter of 2026

Total revenues were $3.8 billion, up 5% on a reported basis and up 3.5% on an operational basis compared to second-quarter 2025 results, primarily driven by new product sales in Developed Markets and strong growth in Greater China. Brands net sales reflect continued strength in Greater China and Emerging Markets. Generics net sales reflect contributions from new product launches, in addition to growth in certain products in Developed Markets, partially offset by supply constraints in the ARV business within Emerging Markets. The Company generated approximately $101 million in new product revenues (approximately $172 million for the year) and continues expecting to deliver approximately $450 million to $550 million in new product revenues in full-year 2026. U.S. GAAP net loss was $119 million compared to U.S. GAAP net loss of $5 million in the second quarter of 2025 and U.S. GAAP diluted loss per share was $(0.10) compared to a loss of less than $(0.01) per share in the second quarter of 2025. The loss in the second quarter of 2026 was primarily driven by a non-cash charge of $177.8 million related to the planned sale of the product rights for Tyrvaya® and the write down of that intangible asset to fair value, less cost to sell. Adjusted EBITDA was $1.2 billion, up 10% on a reported basis and up 8% on an operational basis compared to the second quarter of 2025, and adjusted EPS was $0.69 per share, up 11% on a reported basis and up 9% on an operational basis compared to the second quarter of 2025. The Company generated U.S. GAAP net cash provided by operating activities of $382 million ($770 million for the year) and free cash flow, excluding the impact of transaction-related and restructuring-related costs, of $449 million ($908 million for the year). Additional Highlights

In August, the Company signed a definitive agreement to sell the global product rights for Tyrvaya to Harrow, Inc., a leading provider of ophthalmic disease management solutions in North America, for an upfront payment of $30 million and an additional $70 million in commercial contingent milestone payments. The transaction reflects the Company's continued focus on prioritizing its capital, talent and resources toward opportunities it believes offer the greatest long-term growth potential. In July, the Company announced that the U.S. Food and Drug Administration (FDA) approved Gwyn LoTM (norelgestromin and ethinyl estradiol transdermal system), a new combined hormonal contraceptive patch with low-dose estrogen. The Company expects Gwyn Lo to be commercially available later this year. In July, the Company completed the sale of its equity position in Biocon Limited for a pre-tax total consideration of approximately $380 million. The pre-tax sale proceeds include the impacts of an approximate 2.7% block sale discount to market, transaction fees and the strengthening of the U.S. dollar since the Company obtained the equity in January 2026. This sale completes the Company's monetization of its stake in Biocon Biologics Limited for a total of approximately $780 million.  In June, the FDA approved the Company's generic ferric carboxymaltose injection in three strengths: 750 mg/15 mL, 1000 mg/20 mL and 100 mg/2 mL. Ferric carboxymaltose is a substitutable generic version of Injectafer®, which is indicated for the treatment of iron deficiency anemia and non-dialysis dependent chronic kidney disease, and iron deficiency. In June, the Company announced positive top-line results from a Phase 3 clinical trial evaluating the efficacy and safety of VR-205 (targeted-release budesonide formulation) (Nefecon®) in Japanese adult patients with primary immunoglobulin A nephropathy at risk of developing end-stage renal disease. In May, the FDA inspected the Company's oral solid dose manufacturing facility in Nashik, India, and issued Form 483 observations. The Company responded to the Form 483 observations and promptly initiated a comprehensive remediation plan. The Company has also engaged independent third-party subject matter experts to support its remediation plan. Activities under the remediation plan are ongoing and have led to intermittent disruptions at the facility. While production at the facility has resumed, the temporary manufacturing suspension due to the fire at the facility in February along with these intermittent disruptions are expected to impact product supply in the second half of the year. The Company currently anticipates the impact of product supply disruptions to be between $100 million and $150 million to total revenues in the second half of 2026. In May, the Company announced that the FDA accepted for review the New Drug Application for MR-107A-02 (fast-acting meloxicam), a non-opioid, for the treatment of moderate-to-severe acute pain. The FDA has assigned a PDUFA goal date of December 27, 2026. The Company signed a distribution agreement with Accord Healthcare to commercialize three biosimilar products (filgrastim, ustekinumab, teriparatide) in France. In addition, the Company signed a co-promotion partnership with Idorsia Ltd. for Quvivq® in Italy and Canada. These transactions reflect the Company's disciplined business development strategy of expanding its portfolio through complementary, accretive products that leverage its regional capabilities and commercial strengths. Capital Allocation

Through August 5, 2026, the Company has returned approximately $550 million of capital to shareholders, including approximately $270 million through share repurchases at a weighted average purchase price of $16.42 per share. The Company has approximately $730 million remaining under its existing board-authorized share repurchase program, providing continued flexibility to return additional capital to shareholders.

The Company repaid approximately $900 million of debt that matured in June 2026, refinancing the remaining balance with a public offering of €650 million aggregate principal amount of 4.250% euro-denominated senior notes due 2033. As a result, the Company ended the quarter with a gross leverage ratio of 2.9x.

2026 Financial Guidance

Viatris is raising the midpoints of its 2026 financial guidance ranges, each as set forth below. The Company is not providing forward-looking guidance for U.S. GAAP net earnings (loss) or U.S. GAAP diluted earnings (loss) per share (EPS) or a quantitative reconciliation of its 2026 adjusted EBITDA or adjusted EPS guidance to the most directly comparable U.S. GAAP measures, U.S. GAAP net earnings (loss) or U.S. GAAP diluted EPS, respectively, because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items, including integration, acquisition and divestiture-related expenses, restructuring expenses, asset impairments, litigation settlements, future share repurchases, and other contingencies, such as changes to contingent consideration, acquired IPR&D and certain other gains or losses as well as related income tax accounting, because certain of these items have not occurred, are out of the Company's control and/or cannot be reasonably predicted without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on U.S. GAAP reported results for the guidance period. With respect to the Estimated Ranges as provided on August 6, 2026, U.S. GAAP net cash provided by operating activities for 2026 is estimated to be between $1.9 billion and $2.1 billion, with a midpoint of approximately $2.0 billion. With respect to the Estimated Ranges reaffirmed on May 7, 2026, U.S. GAAP net cash provided by operating activities for 2026 was estimated to be between $1.7 billion and $2.0 billion, with a midpoint of approximately $1.85 billion.

(In millions, except Adjusted EPS)

Estimated Ranges (2)

May 7, 2026

Midpoint (2)

May 7, 2026

Estimated Ranges (3)

August 6, 2026

Midpoint (3)

August 6, 2026

Total Revenues

$14,450 - $14,950

$14,700

$14,550 - $14,950

$14,750

Adjusted EBITDA (1)

$4,150 - $4,450

$4,300

$4,300 - $4,500

$4,400

Adjusted EPS (1)

$2.33 - $2.47

$2.40

$2.45 - $2.59

$2.52

Free Cash Flow (1)

Excluding Transaction-related and Restructuring-related Costs

$1,950 - $2,350

$2,150

$2,050 - $2,350

$2,200

(1)

Non-GAAP financial measures. See "Non-GAAP Financial Measures" for additional information.

(2)

2026 Financial Guidance reaffirmed on May 7, 2026, excluded any acquired IPR&D for unsigned deals to be incurred in any future period as it could not be reasonably forecasted. 

(3)

2026 Financial Guidance as provided on August 6, 2026, excludes any acquired IPR&D for unsigned deals to be incurred in any future period as it cannot be reasonably forecasted.

Conference Call and Earnings Materials 

As previously announced, Viatris will host a conference call and live webcast, today at 8:30 a.m. ET, to review the Company's second-quarter 2026 financial results. Investors and the general public are invited to listen to a live webcast of the call at investor.viatris.com or by calling 844.308.3344 or 412.317.1896 for international callers. The "Viatris Q2 2026 Earnings Presentation," which will be referenced during the call, can be found at investor.viatris.com. A replay of the webcast also will be available on the website.

About Viatris

Viatris Inc. (Nasdaq: VTRS) is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we strive to deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a broad portfolio that spans generics, value-added medicines, established brands and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, China, and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X.

Non-GAAP Financial Measures

This press release includes the presentation and discussion of certain financial information that differs from what is reported under accounting principles generally accepted in the United States ("U.S. GAAP"). These non-GAAP financial measures, including, but not limited to, adjusted gross profit, adjusted gross margins, adjusted net earnings, adjusted EPS, EBITDA, adjusted EBITDA, free cash flow, free cash flow excluding the impact of transaction-related and restructuring-related costs, adjusted R&D and as a % of total revenues, adjusted SG&A and as a % of total revenues, adjusted earnings from operations, adjusted interest expense, adjusted other income, net, adjusted effective tax rate, constant currency total revenues, constant currency net sales, constant currency adjusted EBITDA, constant currency adjusted EPS, notional debt, gross leverage ratio and long-term gross leverage ratio target, are presented in order to supplement investors' and other readers' understanding and assessment of the financial performance of Viatris Inc. ("Viatris" or the "Company"). Free cash flow refers to U.S. GAAP net cash provided by operating activities less capital expenditures. Management uses these measures internally for forecasting, budgeting, measuring its operating performance, and incentive-based awards. Primarily due to acquisitions, divestitures and other significant events which may impact comparability of our periodic operating results, Viatris believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results was limited to financial measures prepared only in accordance with U.S. GAAP. We believe that non-GAAP financial measures are useful supplemental information for our investors and when considered together with our U.S. GAAP financial measures and the reconciliation to the most directly comparable U.S. GAAP financial measure, provide a more complete understanding of the factors and trends affecting our operations. The financial performance of the Company is measured by senior management, in part, using adjusted metrics included herein, along with other performance metrics. In addition, the Company believes that including EBITDA and supplemental adjustments applied in presenting adjusted EBITDA is appropriate to provide additional information to investors to demonstrate the Company's ability to comply with financial debt covenants and assess the Company's ability to incur additional indebtedness. The Company also believes that adjusted EBITDA better focuses management on the Company's underlying operational results and true business performance and is used, in part, for management's incentive compensation. We also report sales performance using the non-GAAP financial measures of "constant currency", also referred to herein as "operational change", total revenues, net sales, adjusted EBITDA, and adjusted EPS. These measures provide information on the change in total revenues, net sales, adjusted EBITDA, and adjusted EPS assuming that foreign currency exchange rates had not changed between the prior and current period. The comparisons presented at constant currency rates reflect comparative local currency sales at the prior year's foreign exchange rates. We routinely evaluate our net sales, total revenues, adjusted EBITDA, and adjusted EPS performance at constant currency so that sales results can be viewed without the impact of foreign currency exchange rates, thereby facilitating a period-to-period comparison of our operational activities and believe that this presentation also provides useful information to investors for the same reason. The "Summary of Total Revenues by Segment" table below compares total revenues and net sales on an actual and constant currency basis for each reportable segment for the three and six months ended June 30, 2026 and 2025. Also, set forth below, Viatris has provided reconciliations of such non-GAAP financial measures to the most directly comparable U.S. GAAP financial measures. Investors and other readers are encouraged to review the related U.S. GAAP financial measures and the reconciliations of the non-GAAP measures to their most directly comparable U.S. GAAP measures set forth below, and investors and other readers should consider non-GAAP measures only as supplements to, not as substitutes for or as superior measures to, the measures of financial performance prepared in accordance with U.S. GAAP. For additional information regarding the components and uses of non-GAAP financial measures refer to Management's Discussion and Analysis of Financial Condition and Results of Operations--Use of Non-GAAP Financial Measures section of Viatris' Quarterly Report on Form 10-Q for the three and six months ended June 30, 2026.

With respect to the guidance ranges reaffirmed on May 7, 2026, at that time the Company did not provide forward-looking guidance for U.S. GAAP net earnings (loss) or U.S. GAAP diluted EPS or a quantitative reconciliation of its 2026 adjusted EBITDA or adjusted EPS guidance to the most directly comparable U.S. GAAP measures, U.S. GAAP net earnings (loss) or U.S. GAAP diluted EPS, respectively, because it was unable to predict with reasonable certainty the ultimate outcome of certain significant items, including integration, acquisition and divestiture-related expenses, restructuring expenses, asset impairments, litigation settlements, future share repurchases, and other contingencies, such as changes to contingent consideration, acquired IPR&D and certain other gains or losses, including for the fair value accounting impact for equity investments, as well as related income tax accounting, because certain of these items had not occurred, were out of the Company's control, and/or could not be reasonably predicted without unreasonable effort. These items were uncertain, depended on various factors, and could have had a material impact on U.S. GAAP reported results for the guidance period. As previously disclosed, such guidance ranges excluded the impact of transaction-related and restructuring-related costs as well as any acquired IPR&D for unsigned deals to be incurred in any future period as it could not be reasonably forecasted. With respect to the Estimated Ranges reaffirmed on May 7, 2026, U.S. GAAP net cash provided by operating activities for 2026 was estimated to be between $1.7 billion and $2.0 billion, with a midpoint of approximately $1.85 billion.

Certain Key Terms and Presentation Matters

New product sales, new product launches or new product revenues: Refers to revenue from new products launched in 2026 and the carryover impact of new products, including business development, launched within the last 12 months.

Operational change: Refers to constant currency percentage changes and is derived by translating amounts for the current period at prior year comparative period exchange rates and in doing so shows the percentage change from 2026 constant currency net sales, total revenues, adjusted EBITDA, and adjusted EPS to the corresponding amount in the prior year.

Transaction-related costs: Refers to the impact of any acquisition and divestiture-related transaction costs, including taxes.

Restructuring-related costs: Refers to the impact of any cash costs associated with the restructuring activities of the enterprise-wide strategic review, which are expected to be primarily related to severance and employee benefits expense, as well as other costs, including those related to contract terminations, vendor consolidations, product transfer costs and network related simplification and modernization costs.

Forward-Looking Statements

This press release contains "forward-looking statements". These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include, without limitation, statements about our 2026 financial guidance; our second-quarter results reflect another quarter of strong execution and reinforce the momentum we're building across our business; commercial execution, pipeline progress and the early benefits of our enterprise-wide strategic review continue strengthening our business and improving our financial performance; our strong first-half results give us the confidence to raise our full-year guidance; we expect a more balanced operating environment in the second half of the year and we remain focused on disciplined execution, investing behind our future growth drivers and creating long-term value for patients and shareholders; we delivered another strong quarter of Total Revenues and Adjusted EBITDA growth over the prior year, reflecting continued strong operational execution; at the same time, we continued to execute on our balanced capital allocation strategy, returning approximately $550 million to shareholders, including approximately $270 million of share repurchases occurring through early August; in addition, we further strengthened our balance sheet and reduced our gross leverage ratio to 2.9x; the Company generated approximately $101 million in new product revenues (approximately $172 million for the year) and continues expecting to deliver approximately $450 million to $550 million in new product revenues in full-year 2026; the transaction to sell the global product rights for Tyrvaya® reflects the Company's continued focus on prioritizing its capital, talent and resources toward opportunities it believes offer the greatest long-term growth potential; the Company expects Gwyn Lo to be commercially available later this year; the outcomes of clinical trials; in May, the FDA inspected the Company's oral solid dose manufacturing facility in Nashik, India, and issued Form 483 observations; the Company responded to the Form 483 observations and promptly initiated a comprehensive remediation plan; the Company has also engaged independent third-party subject matter experts to support its remediation plan; activities under the remediation plan are ongoing and have led to intermittent disruptions at the facility; while production at the facility has resumed, the temporary manufacturing suspension due to the fire at the facility in February along with these intermittent disruptions are expected to impact product supply in the second half of the year; the Company currently anticipates the impact of product supply disruptions to be between $100 million and $150 million to total revenues in the second half of 2026; in May, the Company announced that the FDA accepted for review the New Drug Application for MR-107A-02 (fast-acting meloxicam), a non-opioid, for the treatment of moderate-to-severe acute pain and the FDA has assigned a PDUFA goal date of December 27, 2026; the Company signed a distribution agreement with Accord Healthcare to commercialize three biosimilar products (filgrastim, ustekinumab, teriparatide) in France; the Company signed a co-promotion partnership with Idorsia Ltd. for Quvivq® in Italy and Canada; these transactions reflect the Company's disciplined business development strategy of expanding its portfolio through complementary, accretive products that leverage its regional capabilities and commercial strengths; the Company has approximately $730 million remaining under its existing board-authorized share repurchase program, providing continued flexibility to return additional capital to shareholders; the goals or outlooks with respect to the Company's strategic initiatives and priorities, including but not limited to divestitures, acquisitions, strategic alliances, collaborations, or other potential transactions; the anticipated benefits of such strategic initiatives or priorities or restructuring activities; future opportunities for the Company and its products; the outcomes of clinical trials and research studies; R&D and new product development; and any other statements regarding the Company's future operations, financial or operating results, capital allocation, dividend policy and payments, share repurchases, debt ratio and covenants, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, imperatives, competitions, commitments, confidence in future results, efforts to create, enhance or otherwise unlock value, and other expectations and targets for future periods. Forward-looking statements may often be identified by the use of words such as "will", "may", "could", "should", "would", "project", "believe", "anticipate", "expect", "plan", "estimate", "forecast", "potential", "pipeline", "intend", "continue", "target", "seek" and variations of these words or comparable words. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the possibility that the Company may not realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives and priorities; the possibility that the Company may be unable to achieve the intended or expected benefits of its enterprise-wide strategic review and related cost-saving and restructuring activities within the expected timeframe or at all; the possibility that the Company may be unable to achieve intended or expected benefits in connection with divestitures, acquisitions, strategic alliances, collaborations, or other transactions, or restructuring programs, within the expected timeframes or at all; goodwill or impairment charges or other losses; success of clinical trials and the Company's or its partners' ability to execute on new product opportunities and develop, manufacture and commercialize products; any changes in or difficulties with the Company's manufacturing facilities, including with respect to short- or long-term shutdowns, inspections, remediation and restructuring activities, supply chain continuity, inventory management, or the ability to meet anticipated demand; the Company's failure to achieve expected or targeted future financial and operating performance and results; the potential impact of natural or man-made disasters, public health outbreaks, fires, accidents, weather, unrest or other emergencies in regions where we or our partners or suppliers operate; actions and decisions of healthcare and pharmaceutical regulators; changes in relevant laws, regulations and policies and/or the application or implementation thereof, including but not limited to tax, healthcare and pharmaceutical laws, regulations and policies globally; the ability to attract, motivate and retain key personnel; the Company's liquidity, capital resources and ability to obtain financing; any regulatory, legal or other impediments to the Company's ability to bring new products to market; products in development that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; the scope, timing and outcome of any ongoing legal proceedings, including government inquiries or investigations, and the impact of any such proceedings on the Company; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with having significant operations globally; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; 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 an adverse regulatory action, acquisition or divestiture; the impacts of competition, including decreases in sales or revenues as a result of the loss of market exclusivity for certain products; changes in the economic and financial conditions of the Company or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, wars or other conflicts, potential for adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and inherent uncertainties involved in the estimates and judgments used in the preparation of financial statements, and the providing of estimates of financial measures, in accordance with U.S. GAAP and related standards or on an adjusted basis. For more detailed information on the risks and uncertainties associated with Viatris, see the risks described in Part I, Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2025, and our other filings with the SEC. You can access Viatris' filings with the SEC through the SEC website at www.sec.gov or through our website, and Viatris strongly encourages you to do so. Viatris routinely posts information that may be important to investors on our website at investor.viatris.com, and we use this website address as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). The contents of our website are not incorporated into this press release or our filings with the SEC. Viatris undertakes no obligation to update any statements herein for revisions or changes after the date of this press release other than as required by law.

Viatris Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(Unaudited)

Three Months Ended

Six Months Ended

June 30,

June 30,

(In millions, except per share amounts)

2026

2025

2026

2025

Revenues:

Net sales

$    3,745.9

$    3,569.0

$    7,255.6

$    6,812.2

Other revenues

10.9

13.1

18.2

24.2

Total revenues

3,756.8

3,582.1

7,273.8

6,836.4

Cost of sales

2,300.3

2,249.2

4,660.1

4,342.3

Gross profit

1,456.5

1,332.9

2,613.7

2,494.1

Operating expenses:

Research and development

248.3

218.8

496.9

440.8

Acquired IPR&D

(5.8)



0.2

10.0

Selling, general and administrative

1,134.5

928.7

2,063.3

1,876.8

Impairment of goodwill







2,936.8

Litigation settlements and other contingencies, net

73.2

(47.6)

126.7

(121.1)

Total operating expenses

1,450.2

1,099.9

2,687.1

5,143.3

Earnings (loss) from operations

6.3

233.0

(73.4)

(2,649.2)

Interest expense

120.7

116.6

240.8

232.1

Other (income) expense, net

(50.4)

333.5

(2.9)

432.8

Loss before income taxes

(64.0)

(217.1)

(311.3)

(3,314.1)

Income tax provision (benefit)

54.8

(212.5)

(368.9)

(267.5)

Net (loss) earnings

$     (118.8)

$       (4.6)

$       57.6

$  (3,046.6)

(Loss) earnings per share attributable to Viatris Inc. shareholders

Basic

$       (0.10)

$          —

$       0.05

$       (2.58)

Diluted

$       (0.10)

$          —

$       0.05

$       (2.58)

Weighted average shares outstanding:

Basic

1,163.3

1,173.0

1,159.4

1,182.7

Diluted

1,163.3

1,173.0

1,173.8

1,182.7

Viatris Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(Unaudited)

(In millions)

June 30,
2026

December 31,
2025

ASSETS

Assets

Current assets:

Cash and cash equivalents

$        886.5

$      1,322.4

Accounts receivable, net

3,126.2

3,031.3

Inventories

3,933.2

3,999.2

Prepaid expenses and other current assets

2,109.8

1,436.3

Total current assets

10,055.7

9,789.2

Intangible assets, net

13,676.9

15,102.1

Goodwill

6,654.4

6,754.7

Other non-current assets

4,657.6

5,547.1

Total assets

$    35,044.6

$    37,193.1

LIABILITIES AND EQUITY

Liabilities

Current portion of long-term debt and other long-term obligations

$      1,738.9

$      1,933.3

Other current liabilities

4,606.9

5,161.0

Long-term debt

11,612.4

12,480.6

Other non-current liabilities

2,826.0

2,906.9

Total liabilities

20,784.2

22,481.8

Shareholders' equity

14,260.4

14,711.3

Total liabilities and equity

$    35,044.6

$    37,193.1

Viatris Inc. and Subsidiaries

Key Product Net Sales, on a Consolidated Basis

(Unaudited)

Three months ended June 30,

Six months ended June 30,

(In millions)

2026

2025

2026

2025

Select Key Global Products

Lipitor ®

$          452.2

$          387.9

$          914.2

$          775.9

Norvasc ®

200.2

182.7

410.2

355.0

EpiPen® Auto-Injectors

129.2

136.8

230.3

233.5

Lyrica ®

120.6

128.1

241.2

240.7

Viagra ®

112.9

100.3

207.9

198.8

Creon ®

97.4

91.4

194.8

173.8

Celebrex ®

76.4

70.0

143.5

133.4

Zoloft ®

71.4

61.1

144.0

121.3

Effexor ®

66.7

63.1

128.7

122.4

Xalabrands

38.8

40.7

78.0

77.8

Select Key Segment Products

Yupelri ®

70.7

66.6

$          133.2

$          124.9

Dymista ®

39.8

48.4

77.1

91.2

Amitiza ®

39.4

41.6

73.4

74.9

Xanax ®

38.1

33.9

72.9

66.2

____________

(a)

The Company does not disclose net sales for any products considered competitively sensitive.

(b)

Products disclosed may change in future periods, including as a result of seasonality, competition or new product launches.

(c)

Amounts include the impact of foreign currency fluctuations compared to the prior year period.

Viatris Inc. and Subsidiaries 
Reconciliation of Non-GAAP Financial Measures 
(Unaudited)

Reconciliation of U.S. GAAP Net (Loss) Earnings to Adjusted Net Earnings and U.S. GAAP (Loss) Earnings Per Share to Adjusted EPS

Below is a reconciliation of U.S. GAAP net (loss) earnings and diluted (loss) earnings per share to adjusted net earnings and adjusted EPS for the three and six months ended June 30, 2026, compared to the prior year period: 

Three Months Ended June 30,

Six Months Ended June 30,

(In millions, except per share amounts)

2026

2025

2026

2025

U.S. GAAP net (loss) earnings and U.S. GAAP diluted (loss) earnings per share

$ (118.8)

$         (0.10)

$   (4.6)

$   —

$   57.6

$ 0.05

$         (3,046.6)

$ (2.58)

Purchase accounting amortization (primarily included in cost of sales)

586.4

597.8

1,177.9

1,181.3

Impairment of goodwill







2,936.8

Litigation settlements and other contingencies, net

73.2

(47.6)

126.7

(121.1)

Interest expense (primarily amortization of premiums and discounts on long term debt)

(10.2)

(9.5)

(20.3)

(18.7)

Loss on divestitures of businesses (included in other (income) expense, net)



43.8

13.9

80.7

Acquisition and divestiture-related costs (primarily included in cost of sales and SG&A)(a)

51.4

53.7

113.7

94.4

Restructuring costs (b)

47.8

26.6

140.3

119.5

Share-based compensation expense

38.7

37.1

86.9

92.3

Other special items included in:

Cost of sales (c)

56.3

59.1

198.7

100.7

Research and development expense

1.1

1.4

3.9

2.1

Selling, general and administrative expense (d)

241.1

30.1

276.5

47.7

Other (income) expense, net (e)

(35.8)

304.6

25.5

406.0

Tax effect of the above items and other income tax related items (f)

(122.7)

(366.5)

(698.7)

(548.8)

Adjusted net earnings and adjusted EPS

$ 808.5

$ 0.69

$ 726.0

$ 0.62

$         1,502.6

$ 1.28

$ 1,326.3

$ 1.11

Weighted average diluted shares outstanding

1,172.4

1,176.8

1,173.8

1,189.9

____________

Significant items include the following:

(a)

Acquisition and divestiture-related costs consist primarily of contractual obligations related to divestitures, transaction costs including legal and consulting fees, and integration activities.

(b)

For the three and six months ended June 30, 2026, charges include approximately $26.9 million and $76.7 million in cost of sales, approximately $2.0 million and $2.6 million in R&D, and approximately $19.0 million and $61.0 million in SG&A, primarily relating to the 2026 restructuring program.

(c)

For the three and six months ended June 30, 2026, includes certain asset impairments, contractual termination costs, and incremental manufacturing variances and certain remediation costs at plants slated for sale or closure or undergoing remediation activities of approximately $44.2 million and $174.9 million, respectively, including charges of $14.9 million and $86.8 million, respectively, primarily related to the write off of inventory and fixed assets damaged in the fire at the Nashik manufacturing facility and incremental manufacturing variances.

(d)

For the three and six months ended June 30, 2026, includes a charge of $177.8 million related to the planned sale of the product rights for Tyrvaya®.

(e)

For the three and six months ended June 30, 2026, charges include a (gain)/loss of approximately $(56.3) million and $8.6 million, respectively, as a result of changes in the fair value of the Biocon Limited equity shares.

(f)

Adjusted for changes for uncertain tax positions. 

Reconciliation of U.S. GAAP Net (Loss) Earnings to EBITDA and Adjusted EBITDA

Below is a reconciliation of U.S. GAAP net (loss) earnings to EBITDA and adjusted EBITDA for the three and six months ended June 30, 2026, compared to the prior year period:

Three Months Ended

Six Months Ended

June 30,

June 30,

(In millions)

2026

2025

2026

2025

U.S. GAAP net (loss) earnings

$    (118.8)

$       (4.6)

$       57.6

$  (3,046.6)

Add / (deduct) adjustments:

Income tax provision (benefit)

54.8

(212.5)

(368.9)

(267.5)

Interest expense (a)

120.7

116.6

240.8

232.1

Depreciation and amortization (b)

672.3

678.3

1,348.4

1,343.0

EBITDA

$     729.0

$     577.8

$   1,277.9

$  (1,739.0)

Add / (deduct) adjustments:

Share-based compensation expense

38.7

37.1

86.9

92.3

Litigation settlements and other contingencies, net

73.2

(47.6)

126.7

(121.1)

Loss on divestitures of businesses



43.8

13.9

80.7

Impairment of goodwill







2,936.8

Restructuring, acquisition and divestiture-related and other special items (c)

347.4

467.7

732.4

752.6

Adjusted EBITDA

$   1,188.3

$   1,078.8

$   2,237.8

$   2,002.3

____________

(a)

Includes amortization of premiums and discounts on long-term debt.

(b)

Includes purchase accounting related amortization.

(c)

See items detailed in the Reconciliation of U.S. GAAP Net (Loss) Earnings to Adjusted Net Earnings.

Summary of Total Revenues by Segment

Three Months Ended

June 30,

(In millions, except %s)

2026

2025

%
Change

2026
Currency
Impact (1)

2026
Constant
Currency
Revenues

Constant
Currency %
Change (2)

Net sales

Developed Markets

$ 2,193.7

$ 2,119.3

4 %

$   (30.8)

$  2,162.9

2 %

Greater China

713.8

588.9

21 %

(28.6)

685.2

16 %

JANZ

296.1

305.7

(3) %

8.1

304.2

— %

Emerging Markets

542.3

555.1

(2) %

2.1

544.4

(2) %

Total net sales

3,745.9

3,569.0

5 %

(49.2)

3,696.7

4 %

Other revenues (3)

10.9

13.1

NM

(0.1)

10.8

NM

Consolidated total revenues (4)

$ 3,756.8

$ 3,582.1

5 %

$   (49.3)

$  3,707.5

4 %

Six Months Ended

June 30,

(In millions, except %s)

2026

2025

%
Change

2026
Currency
Impact (1)

2026
Constant
Currency
Revenues

Constant
Currency %
Change (2)

Net sales

Developed Markets

$ 4,214.5

$ 4,011.0

5 %

$  (148.5)

$  4,066.0

1 %

Greater China

1,393.9

1,144.4

22 %

(54.2)

1,339.7

17 %

JANZ

569.5

581.8

(2) %

4.3

573.8

(1) %

Emerging Markets

1,077.7

1,075.0

— %

(12.5)

1,065.2

(1) %

Total net sales

$ 7,255.6

$ 6,812.2

7 %

$  (210.9)

$  7,044.7

3 %

Other revenues (3)

18.2

24.2

NM

(0.2)

18.0

NM

Consolidated total revenues (4)

$ 7,273.8

$ 6,836.4

6 %

$  (211.1)

$  7,062.7

3 %

____________

(1)

Currency impact is shown as unfavorable (favorable).

(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 2026 constant currency net sales or revenues to the corresponding amount in the prior year.

(3)

For the three months ended June 30, 2026, other revenues in Developed Markets, JANZ, and Emerging Markets were approximately $9.3 million, $0.1 million, and $1.5 million, respectively. For the six months ended June 30, 2026, other revenues in Developed Markets, JANZ, and Emerging Markets were approximately $14.5 million, $0.2 million, and $3.5 million, respectively.

(4)

Amounts exclude intersegment revenue which eliminates on a consolidated basis.

Reconciliation of Statements of Operations Line Items

(Unaudited)

Three Months Ended

Six Months Ended

June 30,

June 30,

(In millions, except %s)

2026

2025

2026

2025

U.S. GAAP cost of sales

$   2,300.3

$   2,249.2

$   4,660.1

$   4,342.3

Deduct:

Purchase accounting amortization and other related items

(586.4)

(597.8)

(1,177.9)

(1,181.3)

Acquisition and divestiture-related costs

(32.0)

(26.4)

(60.4)

(38.6)

Restructuring costs

(26.9)

(11.3)

(76.7)

(31.1)

Share-based compensation expense

(0.8)

(0.9)

(1.8)

(2.2)

Other special items, including restructuring related costs

(56.3)

(59.1)

(198.7)

(100.7)

Adjusted cost of sales

$   1,597.9

$   1,553.7

$   3,144.6

$   2,988.4

Adjusted gross profit (a)

$   2,158.9

$   2,028.4

$   4,129.2

$   3,848.0

Adjusted gross margin (a)

57 %

57 %

57 %

56 %

Three Months Ended

Six Months Ended

June 30,

June 30,

(In millions, except %s)

2026

2025

2026

2025

U.S. GAAP R&D

$     248.3

$     218.8

$     496.9

$     440.8

Deduct:

Acquisition and divestiture-related costs

(1.1)

(2.6)

(3.1)

(3.3)

Restructuring costs

(2.0)

(1.4)

(2.6)

(2.2)

Share-based compensation expense

(2.1)

(2.2)

(4.8)

(4.5)

Other special items

(1.1)

(1.4)

(3.9)

(2.1)

Adjusted R&D

$     242.0

$     211.2

$     482.5

$     428.7

Adjusted R&D as % of total revenues

6 %

6 %

7 %

6 %

Three Months Ended

Six Months Ended

June 30,

June 30,

(In millions, except %s)

2026

2025

2026

2025

U.S. GAAP SG&A

$   1,134.5

$     928.7

$   2,063.3

$   1,876.8

Deduct:

Acquisition and divestiture-related costs

(18.1)

(24.7)

(50.1)

(52.5)

Restructuring costs

(19.0)

(14.0)

(61.0)

(86.3)

Share-based compensation expense

(35.8)

(33.9)

(80.3)

(85.6)

Other special items and reclassifications

(241.1)

(30.1)

(276.5)

(47.7)

Adjusted SG&A

$     820.5

$     826.0

$   1,595.4

$   1,604.7

Adjusted SG&A as % of total revenues

22 %

23 %

22 %

23 %

Three Months Ended

Six Months Ended

June 30,

June 30,

(In millions)

2026

2025

2026

2025

U.S. GAAP total operating expenses

$     1,450.2

$     1,099.9

$   2,687.1

$   5,143.3

Add / (Deduct):

Litigation settlements and other contingencies, net

(73.2)

47.6

(126.7)

121.1

R&D adjustments

(6.3)

(7.6)

(14.4)

(12.1)

SG&A adjustments

(314.0)

(102.7)

(467.9)

(272.1)

Impairment of goodwill adjustments







(2,936.8)

Adjusted total operating expenses

$     1,056.7

$     1,037.2

$   2,078.1

$   2,043.4

Adjusted earnings from operations (b)

$     1,102.2

$       991.2

$   2,051.1

$   1,804.6

Three Months Ended

Six Months Ended

June 30,

June 30,

(In millions)

2026

2025

2026

2025

U.S. GAAP interest expense

$       120.7

$       116.6

$     240.8

$     232.1

Add / (Deduct):

Accretion of contingent consideration liability

(0.9)

(1.2)

(1.8)

(2.4)

Amortization of premiums and discounts on long-term debt

11.7

11.4

23.5

22.4

Other special items

(0.7)

(0.7)

(1.4)

(1.3)

Adjusted interest expense

$       130.8

$       126.1

$     261.1

$     250.8

Three Months Ended

Six Months Ended

June 30,

June 30,

(In millions)

2026

2025

2026

2025

U.S. GAAP other (income) expense, net

$       (50.4)

$       333.5

$      (2.9)

$     432.8

Add / (Deduct):

Fair value adjustments on non-marketable equity investments



(284.0)



(399.8)

Fair value adjustments on marketable equity investments

56.3



(8.6)



Loss on divestitures of businesses



(43.8)

(13.9)

(80.7)

Other items

(20.7)

(20.5)

(17.0)

(6.1)

Adjusted other income, net

$       (14.8)

$       (14.8)

$     (42.4)

$     (53.8)

Three Months Ended

Six Months Ended

June 30,

June 30,

(In millions, except %s)

2026

2025

2026

2025

U.S. GAAP loss before income taxes

$      (64.0)

$    (217.1)

$     (311.3)

$  (3,314.1)

Total pre-tax non-GAAP adjustments

1,050.0

1,097.1

2,143.7

4,921.8

Adjusted earnings before income taxes

$     986.0

$     880.0

$   1,832.4

$   1,607.7

U.S. GAAP income tax provision (benefit)

$       54.8

$    (212.5)

$     (368.9)

$     (267.5)

Adjusted tax expense

122.7

366.5

698.7

548.8

Adjusted income tax provision

$     177.5

$     154.0

$      329.8

$      281.3

Adjusted effective tax rate

18.0 %

17.5 %

18.0 %

17.5 %

___________

(a)

U.S. GAAP gross profit is calculated as total revenues less U.S. GAAP cost of sales. U.S. GAAP gross margin is calculated as U.S. GAAP gross profit divided by total revenues. Adjusted gross profit is calculated as total revenues less adjusted cost of sales. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues.

(b)

U.S. GAAP earnings from operations is calculated as U.S. GAAP gross profit less U.S. GAAP total operating expenses. Adjusted earnings from operations is calculated as adjusted gross profit less adjusted total operating expenses. 

Reconciliation of Estimated 2026 U.S. GAAP Net Cash Provided by Operating Activities to Free Cash Flow as of August 6, 2026

(Unaudited)

A reconciliation of the estimated 2026 U.S. GAAP Net Cash provided by Operating Activities to Free Cash Flow is presented below:

(In millions)

Estimated U.S. GAAP Net Cash provided by Operating Activities

$1,900 - $2,100

Less: Capital Expenditures

$(350) - $(450)

Free Cash Flow

$1,450 - $1,750

Add: Estimated Transaction-related and Restructuring-related Costs

~$600

Free Cash Flow Excluding Transaction-related and Restructuring-related Costs

$2,050 - $2,350

Reconciliation of Estimated 2026 U.S. GAAP Net Cash Provided by Operating Activities to Free Cash Flow as of May 7, 2026

(Unaudited)

A reconciliation of the estimated 2026 U.S. GAAP Net Cash provided by Operating Activities to Free Cash Flow is presented below:

(In millions)

Estimated U.S. GAAP Net Cash provided by Operating Activities

$1,700 - $2,000

Less: Capital Expenditures

$(350) - $(450)

Free Cash Flow

$1,250 - $1,650

Add: Estimated Transaction-related and Restructuring-related Costs

~$700

Free Cash Flow Excluding Transaction-related and Restructuring-related Costs

$1,950 - $2,350

Gross Leverage Ratio

Gross Leverage Ratio is the ratio of Viatris' total debt at notional amounts at June 30, 2026 to the sum of Viatris' adjusted EBITDA for the quarters ended September 30, 2025, December 31, 2025, March 31, 2026 and June 30, 2026.

Three Months Ended

Twelve
Months
Ended

(In millions, except ratio)

September 30,
2025

December 31,
2025

March 31,
2026

June 30,
2026

June 30, 2026

Adjusted EBITDA

$   1,154.6

$     1,003.1

$    1,049.5

$   1,188.3

$   4,395.5

Reported debt balances:

Long-term debt, including current portion

13,348.6

Short-term borrowings and other current obligations



Total

13,348.6

Add / (deduct):

Net premiums on various debt issuances

(423.7)

Deferred financing fees

23.1

Total debt at notional amounts

$  12,948.0

Gross debt to adjusted EBITDA

          2.9 x

Long-term Gross Leverage Target

The stated forward-looking non-GAAP financial measure of long-term gross leverage target range of 2.8x – 3.2x, is based on the ratio of (i) targeted notional gross debt and (ii) targeted Adjusted EBITDA. However, the Company has not quantified future amounts to develop this target but has stated its goal to manage notional gross debt and Adjusted EBITDA over time in order to generally maintain or reach the target. This target does not reflect Company guidance.

Reconciliation of U.S. GAAP Net (Loss) Earnings to EBITDA and Adjusted EBITDA – Last Twelve Months

Three Months Ended

September 30,
2025

December 31,
2025

March 31,
2026

June 30,
2026

U.S. GAAP net (loss) earnings

$       (128.2)

$       (340.1)

$         176.4

$       (118.8)

Add / (deduct) adjustments:

Income tax provision (benefit)

120.3

(2.9)

(423.7)

54.8

Interest expense (a)

119.6

119.6

120.1

120.7

Depreciation and amortization (b)

688.5

766.8

676.1

672.3

EBITDA

$         800.2

$         543.4

$         548.9

$         729.0

Add / (deduct) adjustments:

Share-based compensation expense

36.0

49.4

48.2

38.7

Litigation settlements and other contingencies, net

55.7

(3.1)

53.5

73.2

(Gain) loss on divestitures of businesses

(1.6)

21.9

13.9



Restructuring, acquisition and divestiture-related and other special items

264.3

391.5

385.0

347.4

Adjusted EBITDA

$      1,154.6

$      1,003.1

$      1,049.5

$      1,188.3

SOURCE Viatris Inc.
2026-08-04 17:41 1mo ago
2026-08-04 12:41 1mo ago
Viatris oznámí výsledky za druhé čtvrtletí 6. srpna
VTRS Viatris
FMP Stock News 78
Original source text
Key Takeaways Viatris to report Q2 results on Aug. 6 with revenue and EPS estimates of $3.68B and 62 cents, respectively.VTRS may see Developed and Emerging Markets growth, partly offset by the Indore import alert and competition.Viatris could benefit from cost-saving efforts, with gross margin expected to remain stable. Viatris (VTRS - Free Report) , a global healthcare company, is scheduled to report second-quarter 2026 results on Aug. 6, before the opening bell.

The Zacks Consensus Estimate for second-quarter revenues is pegged at $3.68 billion, while the same for earnings is pinned at 62 cents per share.

VTRS Q2 Earnings: Factors to ConsiderThe company reports under four segments based on geography — Developed Markets, Emerging Markets, Japan, Australia and New Zealand (“JANZ”) and Greater China.

Developed Markets sales are expected to rise, though growth in North America may be tempered by the Indore manufacturing facility import alert. Solid growth in EpiPen, Creon and Viatris’ thrombosis portfolio is likely to have enabled it to partially absorb the anticipated competition for Dymista. Incremental revenues from new products, such as iron sucrose, are likely to have boosted the quarterly top line.

Following an inspection of Viatris' oral finished dose manufacturing facility in Indore, India, in June 2024, the company received a warning letter and import alert from the FDA in December 2024. The import alert affected 11 actively distributed products, including lenalidomide and everolimus. The Zacks Consensus Estimate for revenues from Developed Markets is pinned at $2.18 billion.

Sales from Emerging Markets are expected to have experienced growth, driven by branded business in Turkey, Mexico and certain Asian markets. The generic business is likely to have seen growth due to the stabilization of supply for certain lower-margin ARB products. The Zacks Consensus Estimate for revenues from this geography is pegged at $558.5 million.

Viatris shares have surged 41.6% year to date against the industry’s 1.1% decline.

Image Source: Zacks Investment Research

Sales in JANZ are likely to have been adversely impacted by lower net sales of existing products in Japan and Australia due to government price reductions and additional competition. The Zacks Consensus Estimate for revenues from the JANZ markets is pinned at $285.1 million.

Sales in Greater China might have increased due to strong growth across multiple channels, including e-commerce, retail and private hospitals, as a result of higher marketing and selling efforts. The Zacks Consensus Estimate for revenues from this geography is pegged at $631.7 million.

Viatris also reports revenues under two divisions (in terms of product category) — brands and generics.

The brand business comprises the majority of the company’s portfolio. Brand performance is likely to have benefited from strong performance in Greater China and Emerging Markets, in addition to growth in certain key brands in Developed Markets.

However, the generics business is likely to have been negatively impacted by inspection at the Indore facility and competition for Wixela, partially offset by continued growth in Yupelri and Breyna in North America, strong performance across key European markets, and slight volume growth in JANZ.

On the profitability front, gross margin is likely to have been stable. Total operating expenses in the second quarter of 2026 are likely to have declined as a result of the planned cost-saving initiatives.

VTRS’ Impeccable Earnings Surprise HistoryViatris’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 10.04%. In the last reported quarter, VTRS beat on earnings by 13.46%.

What Our Model Predicts for ViatrisOur proven model does not conclusively predict an earnings beat for VTRS this time around.  The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here, as you will see below.

Earnings ESP:Viatris has an Earnings ESP of -0.81% as the Most Accurate Estimate of 61 cents per share is just shy of the Zacks Consensus Estimate of 62 cents. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.

Zacks Rank:VTRS currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank stocks here.

Stocks to ConsiderHere are some stocks worth considering from the healthcare space, as our model shows that these have the right combination of elements to beat on earnings this reporting cycle.

ACADIA Pharmaceuticals (ACAD - Free Report) has an Earnings ESP of +25.00% and a Zacks Rank #2 at present.

Shares of ACAD have lost 4.1% year to date. The company’s earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, delivering an average surprise of 20.83%. Acadia is scheduled to report second-quarter results on Aug. 4, after market close.

Arcutis Biotherapeutics (ARQT - Free Report) has an Earnings ESP of +52.94% and a Zacks Rank #2 at present.

Shares of ARQT have lost 10.7% year to date. The company’s earnings beat estimates in three of the trailing four quarters but missed in the remaining quarter, delivering an average surprise of 42.78%. ARQT is scheduled to report second-quarter results on Aug. 5.

BridgeBio Pharma (BBIO - Free Report) has an Earnings ESP of +13.69% and a Zacks Rank #3 at present.

Shares of BBIO have risen 4.5% year to date. BridgeBio Pharma’s earnings missed estimates in each of the trailing four quarters, delivering an average negative surprise of 18.94%.
2026-08-04 12:53 1mo ago
2026-08-04 06:59 1mo ago
Viatris schválila čtvrtletní dividendu 0,12 USD na akcii
VTRS Viatris
FMP Stock News 78
Original source text
, /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS) today announced that on August 3, 2026, its Board of Directors declared a quarterly dividend of $0.12 per share for each issued and outstanding share of the Company's common stock. The dividend is payable on September 16, 2026, to shareholders of record as of the close of business on August 21, 2026.

About Viatris
Viatris Inc. (Nasdaq: VTRS) is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we strive to deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a broad portfolio that spans generics, value-added medicines, established brands, and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, China, and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X.

Forward-Looking Statements
This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements that the Viatris Board of Directors declared a quarterly dividend of $0.12 per share for each issued and outstanding share of the Company's common stock, payable on September 16, 2026, to shareholders of record as of the close of business on August 21, 2026. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: failure to achieve the intended benefits of our strategic initiatives and priorities; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; failure to achieve expected or targeted future financial and operating performance and results; Viatris' or its partners' ability to develop, manufacture, and commercialize products; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.

SOURCE Viatris Inc.
2026-07-29 11:36 1mo ago
2026-07-29 06:59 1mo ago
Viatris získal schválení FDA pro antikoncepční náplast Gwyn Lo
VTRS Viatris
FMP Stock News 86
Original source text
New Patch Will Provide Low-Dose Estrogen Combined Hormonal Contraceptive Option

Approval Marks an Important Milestone in Viatris' Efforts to Advance Women's Health

, /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved Gwyn Lo™ (norelgestromin and ethinyl estradiol transdermal system). Gwyn Lo is a new combined hormonal contraceptive (CHC) patch with low-dose estrogen. The patch has demonstrated contraceptive efficacy for women of childbearing potential with a body mass index (BMI) below 30 kg/m² who are appropriate candidates for CHC. The Gwyn Lo dosage is norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day.

"Gwyn Lo will provide a discreet option for women seeking a reversible, non-invasive, once-weekly contraception patch with a low dose of estrogen," said Philippe Martin, Viatris Chief R&D Officer. "Building on our expertise in transdermal drug delivery systems and legacy in women's health, we are pleased that the approved label for this new patch reflects the strength of our clinical program. This includes demonstrated efficacy in women with a BMI of 25 to less than 30 kg/m², with no BMI-based limitation of use in this population."

The approval was granted under the FDA's 505(b)(2) regulatory pathway and was supported by results from the Phase 3 Luminous Study (NCT05139121), which demonstrated contraceptive efficacy, a well-characterized safety profile and robust patch adhesion performance. Key outcomes of the Phase 3 study included:

The primary efficacy endpoint was the Pearl Index (PI), defined as the number of pregnancies per 100 woman-years of exposure in the efficacy evaluable population (women aged 18 to 35 years), which was 4.14 (95% CI: 2.77 to 5.95). The study demonstrated robust patch adhesion under real-world conditions, with only 1.3% of the 39,790 transdermal systems applied during the year-long trial fully detaching. The most common adverse reactions (2% or greater) reported during the study were application site irritation (4.8%), application site erythema (3.7%), application site pruritus (3.7%), intercycle bleeding (3.9%), heavy withdrawal bleeding (2.0%), and nausea (2.0%). Cycle control improved over time, as rates and duration of unscheduled bleeding or spotting decreased from 34.5% and a mean of 3.2 days in Cycle 1 to 20.0% and 2.4 days by Cycle 13. Data from four Phase 1 studies investigating various application sites and conditions demonstrated consistent drug delivery under conditions including sauna, whirlpool, treadmill exercise and cold-water bath.

Unintended pregnancy remains a significant public health issue in the United States, accounting for 41.6% of pregnancies in 2019.1 Women's contraceptive needs and preferences also vary: in a 2023 CDC survey, 18.1% of women who had used a contraceptive method changed or stopped a method within the previous 12 months.2 Among those women, 42.8% reported that they did not like the method they had been using.2 These findings underscore the continued need for a range of contraceptive options that can align with individual needs and preferences. Gwyn Lo helps address this need by offering a non-invasive, reversible, low-estrogen-dose CHC option for women who prefer once-weekly administration.

The Company expects Gwyn Lo to be commercially available later this year and will provide additional information during its upcoming financial results call.

About Gwyn Lo
Gwyn Lo is a once-weekly transdermal contraceptive patch for women of childbearing potential with a BMI below 30 kg/m² who are appropriate candidates for combined hormonal contraception and who prefer a non-invasive, reversible option with a low estrogen dose. The patch is applied once weekly for three consecutive weeks, followed by one patch-free week, and delivers norelgestromin and ethinyl estradiol over each seven-day wear interval.

Gwyn Lo is a multilayer matrix type transdermal system. The active ingredients and adhesive are contained in a matrix between a backing layer, which consists of a flexible film that provides structural support to the patch, and a release liner that protects the matrix and is removed just prior to application. Upon application to the skin, the system provides controlled delivery of norelgestromin 220 mcg/day and ethinyl estradiol 20 mcg/day throughout the wear interval.

Gwyn Lo is a trademark of Mylan Pharmaceuticals Inc., a Viatris company.

INDICATION AND USAGE
Gwyn Lo is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.

IMPORTANT SAFETY INFORMATION
Gwyn Lo is contraindicated in women who smoke and are over 35 years of age due to an increased risk of serious cardiovascular events. Gwyn Lo is contraindicated in women with a BMI ≥ 30 kg/m2. The risk of VTE may be greater with Gwyn Lo in women with a BMI > 30 kg/m2 compared to women with a lower BMI. Patients should discuss their medical history and risk factors with their healthcare provider before using Gwyn Lo.

Please see Full Prescribing Information.

About Viatris
Viatris Inc. (Nasdaq: VTRS) is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we strive to deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a broad portfolio that spans generics, value-added medicines, established brands, and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, China, and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X.

References

Rossen LM, Hamilton BE, Abma JC, Gregory ECW, Beresovsky V, Resendez AV, et al. Updated methodology to estimate overall and unintended pregnancy rates in the United States. National Center for Health Statistics. Vital Health Stat 2(201). 2023. doi:10.15620/cdc:124395 NCHS Rapid Surveys Systems. Contraception Use. National Center for Health Statistics. Available from: www.cdc.gov/nchs/rss/round2/contraception-use.html. Forward-Looking Statements

This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements about FDA approval for Gwyn Lo; approval marks an important milestone in Viatris' efforts to advance women's health; Gwyn Lo will provide a discreet option for women seeking a reversible, non-invasive, once-weekly contraception patch with a low dose of estrogen; building on our expertise in transdermal drug delivery systems and legacy in women's health, we are pleased that the approved label for this new patch reflects the strength of our clinical program; and the Company expects Gwyn Lo to be commercially available later this year, and will provide additional information during its upcoming financial results call. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the uncertainties inherent in research and development, including the outcomes of clinical trials; the ability to meet anticipated clinical endpoints; the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from clinical studies; failure to achieve the intended benefits of our strategic initiatives and priorities; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; failure to achieve expected or targeted future financial and operating performance and results; Viatris' or its partners' ability to develop, manufacture, and commercialize products; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.

SOURCE Viatris Inc.
2026-06-29 11:46 2mo ago
2026-06-29 06:59 2mo ago
Viatris hlásí úspěch VR-205 ve fázi 3 v Japonsku
VTRS Viatris
FMP Stock News 86
Original source text
VR-205 Met Primary Endpoint and Key Secondary Endpoints and Was Well Tolerated

VR-205 Efficacy and Safety Profile in Japanese Patients Was Consistent with the Profile Observed in Global Studies 

Japanese New Drug Application Submission Targeted by End of 2026

, /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive top-line results from a Phase 3 clinical trial evaluating the efficacy and safety of VR-205 (targeted-release budesonide formulation) (Nefecon®) in Japanese adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of developing end-stage renal disease.

The Phase 3 clinical trial was a multicenter, interventional, open-label study designed to evaluate the efficacy and safety of 16 mg of VR-205 in Japanese adult patients with primary IgAN. Patients were treated for nine months, followed by a three-month follow-up period.

The study achieved its primary endpoint, with VR-205 demonstrating a 33.75 percent reduction in geometric mean urine protein-to-creatinine ratio (UPCR) at 9 months compared to baseline [95% CI: -45.27 to -19.80; p < 0.001]. These results were statistically significant and clinically meaningful, and were consistent with those observed in the global Phase 3 program for the product. Key findings included:

In addition to a statistically significant and clinically meaningful reduction in UPCR at 6 and 12 months, VR-205 demonstrated a significant improvement in estimated glomerular filtration rate (eGFR) and reductions in serum creatinine and urine albumin-to-creatinine ratio (UACR) at 9 months compared to baseline. The overall therapeutic benefit of VR-205 was further supported by improvements in microhematuria and a sustained proteinuria reduction. No study participants progressed to dialysis, kidney transplant or severe renal impairment (eGFR ≤15 mL/min per 1.73 m2) by the end of the study. VR-205 was generally well tolerated over the nine-month treatment period, with a safety profile consistent with the known safety profile of targeted-release budesonide in non-Japanese patients. "We are pleased with these top-line results, which highlight VR-205 as a potentially meaningful, disease-modifying treatment option for patients with primary IgAN," said Viatris Chief R&D Officer Philippe Martin. "In Japan, where IgAN incidence is the highest globally, VR-205 could become the first IgAN-specific, targeted-release budesonide oral therapy. This progress reflects the continued execution of Viatris' strategy focused on building a differentiated and increasingly innovative portfolio in Japan, with an emphasis on delivering therapies that provide meaningful value and address significant unmet needs."

"Primary IgAN is a designated intractable disease in Japan, and remains a significant unmet need, with no curative treatment despite the risk of progression to end-stage renal disease," said Yuko Asami, Head of R&D, Viatris Japan. "These top-line results mark an important step toward expanding treatment options for patients and healthcare providers."

Viatris is targeting submission of a New Drug Application in Japan by the end of 2026.

In 2022, Calliditas Therapeutics AB and Viatris Pharmaceuticals Japan Inc., a subsidiary of Viatris Inc., entered into an exclusive license agreement to obtain marketing authorization and to commercialize VR-205 for the treatment of primary IgAN in Japan. It is currently a specialty drug approved and marketed as Tarpeyo® in the U.S. and as Kinpeygo® in Europe.

About Phase 3 Study (VR-205A-01-CAZ-3001)
The Phase 3 trial was a multicenter, interventional, open-label study conducted in Japan to evaluate the efficacy and safety of oral VR-205 (targeted-release budesonide formulation) for the treatment of primary IgA nephropathy in Japanese adult patients at risk of developing end-stage renal disease. The study enrolled a total of 39 participants who were treated with 16 mg of VR-205 daily (four capsules) over a nine-month treatment period.

Following completion of treatment, participants entered a three-month follow-up period including a two-week dose tapered to 8 mg of VR-205 (two capsules) daily at the start of the follow-up period.

About Immunoglobulin A Nephropathy (IgAN)
IgAN is a progressive, immune-mediated kidney disease and the most common primary glomerulonephritis worldwide. Japan reports the highest incidence rates globally, at 39 to 45 cases per million population per year, with peak age at diagnosis between 30 and 39 years. In Japan, adult-onset IgAN is reported to progress to end-stage renal disease (dialysis or transplantation) in approximately 15-20 percent of patients within 10 years. Most patients reaching end-stage renal disease face decades of dialysis. The total national cost of maintenance hemodialysis in Japan is approximately JPY 1.5 trillion per year. Chronic glomerulonephritis (with IgAN as a leading underlying cause) accounts for 23.4 percent of Japan's more than 340,000 dialysis patients. Despite this burden, therapies that target the underlying immunological drivers of IgAN to preserve long-term kidney function have remained limited, and a clear need persists for disease-modifying treatment options.

About Viatris
Viatris Inc. (Nasdaq: VTRS) is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we strive to deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a dynamic portfolio that spans generics, established brands and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, China, and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X.

Forward-Looking Statements
This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements that positive top-line results from a Phase 3 clinical trial evaluating the efficacy and safety of VR-205 (targeted-release budesonide formulation) (Nefecon®) in Japanese adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of developing end-stage renal disease; VR-205 met primary endpoint and key secondary endpoints, and was well tolerated; VR-205 efficacy and safety profile in Japanese patients was statistically significant and clinically meaningful and were consistent with the profile observed in global studies; we are pleased with these top-line results, which highlight VR-205 as a potentially meaningful, disease-modifying treatment option for patients with primary IgAN; in Japan, where IgAN incidence is the highest globally, VR-205 could become the first IgAN-specific, targeted-release budesonide oral therapy; this progress reflects the continued execution of Viatris' strategy focused on building a differentiated and increasingly innovative portfolio in Japan, with an emphasis on delivering therapies that provide meaningful value and address significant unmet needs; these top-line results mark an important step toward expanding treatment options for patients and healthcare providers; Viatris is targeting submission of a New Drug Application in Japan by the end of 2026. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the uncertainties inherent in research and development, including the outcomes of clinical trials; the ability to meet anticipated clinical endpoints; the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from clinical studies; failure to achieve the intended benefits of our strategic initiatives and priorities; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; failure to achieve expected or targeted future financial and operating performance and results; Viatris' or its partners' ability to develop, manufacture, and commercialize products; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.

SOURCE Viatris Inc.