Executive Summary

Q3 2025 delivered total revenue of $3.76B, slightly above expectations, with adjusted EPS of $0.67 and adjusted EBITDA of $1.15B; GAAP EPS was $(0.11), driven by a fair value loss on Biocon Biologics CCPS and higher tax expense .
Results beat S&P Global Wall Street consensus on revenue ($3.60B*) and EPS ($0.62*), and management raised and narrowed full‑year guidance for total revenue, adjusted EBITDA, and adjusted EPS midpoints to $14.10B, $4.10B, and $2.30, respectively .
Strength in Greater China (+10% YoY) and Emerging Markets (+7% YoY) offset Indore-related headwinds; brands net sales rose 3% YoY, while generics fell 5% YoY .
Capital return remains a catalyst: $920M YTD returned ($500M buybacks) and a declared quarterly dividend of $0.12 per share for payment on Dec 15, 2025 .

What Went Well and What Went Wrong

What Went Well

Outperformed consensus: Q3 revenue of $3.76B and adjusted EPS of $0.67 beat S&P Global Street estimates ($3.60B*, $0.62*); management highlighted “strong operational execution” and raised FY guidance midpoints .
Geographic/brand resilience: Greater China (+10% YoY) and Emerging Markets (+7% YoY) drove growth; brands net sales up 3% YoY with strong EpiPen, Creon, and thrombosis portfolios .
Pipeline/regulatory momentum: NDA submitted for the low-dose estrogen weekly patch (anticipated mid‑2026 approval); FDA approval for iron sucrose injection; acquisition of Aculys adds pitolisant and Spydia® in Japan/APAC .
Quote: “We anticipate being able to deliver meaningful net cost savings over a multi‑year period while also…reinvest[ing]…to fund growth opportunities” — CEO Scott Smith .

What Went Wrong

Indore Impact weighed on generics and margins: adjusted EBITDA down 10% YoY and adjusted gross margin fell to 56.0% from 58.5% .
GAAP loss: $(128)M GAAP net loss and $(0.11) EPS driven by fair value reduction of Biocon Biologics CCPS and higher tax expense .
JANZ down 11% YoY and Developed Markets down 2% YoY; North America generics faced competition and Indore drag, with management guiding normal seasonality to lower Q4 revenues vs Q3 .

Financial Results

Quarterly trend

Metric	Q1 2025	Q2 2025	Q3 2025
Revenue ($USD Billions)	$3.25	$3.58	$3.76
GAAP Diluted EPS ($)	$(2.55)	$0.00	$(0.11)
Adjusted EPS ($)	$0.50	$0.62	$0.67
Adjusted EBITDA ($USD Billions)	$0.92	$1.08	$1.15
GAAP Gross Margin (%)	35.7%	37.2%	36.5%
Adjusted Gross Margin (%)	55.9%	56.6%	56.0%

Q3 2025 vs prior year and estimates

Metric	Q3 2024	Q3 2025	YoY Change	S&P Global Consensus	Surprise
Revenue ($USD Billions)	$3.75	$3.76	~0%	$3.60*	+$0.16B*
GAAP Diluted EPS ($)	$0.08	$(0.11)	NM	—	—
Adjusted EPS ($)	$0.75	$0.67	(11%)	$0.62*	+$0.05*
Adjusted EBITDA ($USD Billions)	$1.28	$1.15	(10%)	$1.08*	+$0.07B*

Values retrieved from S&P Global.*

Segment and category breakdown (Q3 2025)

Segment / Category	Net Sales ($USD Billions)	YoY Change
Developed Markets	$2.26	(2%)
Greater China	$0.62	+10%
JANZ	$0.31	(11%)
Emerging Markets	$0.57	+7%
Brands	$2.44	+3%
Generics	$1.31	(5%)

Selected KPIs

KPI	Q1 2025	Q2 2025	Q3 2025
Cash from Operations ($USD Billions)	$0.54	$0.22	$0.75
Free Cash Flow ($USD Billions)	$0.49	$0.17	$0.66
Capital Expenditures ($USD Billions)	$0.04	$0.05	$0.09
Adjusted R&D as % of Revenue	7%	6%	6%
Adjusted SG&A as % of Revenue	24%	23%	22%

Guidance Changes

Metric	Period	Previous Guidance (Aug 7, 2025)	Current Guidance (Nov 6, 2025)	Change
Total Revenues ($USD Billions)	FY 2025	$13.50 – $14.00; Midpoint $13.75	$13.90 – $14.30; Midpoint $14.10	Raised and narrowed
Adjusted EBITDA ($USD Billions)	FY 2025	$3.89 – $4.19; Midpoint $4.04	$4.00 – $4.20; Midpoint $4.10	Raised midpoint; narrowed range
Adjusted EPS ($)	FY 2025	$2.16 – $2.30; Midpoint $2.23	$2.25 – $2.35; Midpoint $2.30	Raised and narrowed
Free Cash Flow ($USD Billions)	FY 2025	$1.80 – $2.20; Midpoint $2.00	$1.85 – $2.15; Midpoint $2.00	Range narrowed
GAAP Net Cash from Ops ($USD Billions)	FY 2025	$2.20 – $2.50; Midpoint ~$2.35	$2.20 – $2.45; Midpoint ~$2.325	Slightly narrowed
Dividend	Calendar Q4 2025	—	$0.12 per share, payable Dec 15; record Nov 24	Declared dividend

Management also guided Q4 phasing: revenues lower across segments due to seasonality; gross margins stable; SG&A to increase for pipeline/launch investments; FCF to step down given interest timing and capex phasing .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 & Q2 2025)	Current Period (Q3 2025)	Trend
Indore FDA import alert impact	Estimated revenue impact: $140M (Q1) and ~$160M (Q2); generics headwinds	Q3 impact ~$100M; remediation substantially complete; redundancies added; penalties not expected to recur in 2026	Improving
Capital allocation	Reaffirmed $500–$650M buybacks; >$450M returned YTD (Q1) and >$630M YTD (Q2)	$920M returned YTD; $500M repurchases; balanced 50/50 long-term capital return vs growth assets	Strengthening
Pipeline execution	Positive Phase 3 readouts (meloxicam, presbyopia; contraceptive patch NDA planned H2)	NDA filed for low-dose estrogen patch; iron sucrose FDA approval; Aculys acquisition (pitolisant, Spydia®); meloxicam pre‑NDA and opioid‑sparing label ambition	Advancing
Strategic review	Ongoing enterprise-wide review disclosed; focus on efficiencies	Expect “meaningful net cost savings” over multi‑year; quantum to be detailed Q1 2026 investor event	Building
Regional trends	Europe resilient; Greater China +6–9% growth in H1	Greater China +10%; Emerging +7%; JANZ down (price/reimbursement)	Mixed
Regulatory/legal	Goodwill impairment ($2.9B) in Q1; fair value losses on Biocon CCPS in H1	Additional fair value loss (~$100M) in Q3 on Biocon CCPS; continued FDA engagement on Indore	Stabilizing

Management Commentary

“We delivered another strong quarter…advancing our pipeline…preparing to take meaningful actions through our enterprise‑wide strategic review to position Viatris for sustainable growth in 2026 and beyond.” — CEO Scott Smith .
“We have returned more than $920 million of capital to shareholders year‑to‑date…we are raising and narrowing our financial guidance ranges…on track to deliver on all of our 2025 financial commitments.” — CFO Doretta Mistras .
“Initial remediation activities [at Indore] are substantially complete…we met with the FDA…built operational redundancies…to decouple revenues” — CEO Scott Smith .
“We anticipate being able to deliver meaningful net cost savings over a multi‑year period…reinvest a portion…to fund growth opportunities.” — CEO Scott Smith .

Q&A Highlights

Indore remediation and penalties: Management expects penalties (over half of ~$100M Q3 impact) not to recur next year; redundancies built with other sites/third parties while FDA reinspection timing remains at agency discretion .
Meloxicam label and commercialization: Designed Phase 3 with FDA to enable opioid‑sparing labeling; exploring partnerships but prepared to self‑launch; peak sales “in the right sort of range” around ~$500M subject to label .
Capital allocation and BD: Target balanced 50/50 over 3–5 years between shareholder returns and growth assets; leaning into buybacks in 2025; seek accretive US-based innovative assets .
Strategic review quantification: Quantum of savings to be disclosed in Q1 2026; majority of savings expected to drop to bottom line with minority reinvestment .
2026 setup: Q4 seasonality to lower revenue vs Q3; watch competitive dynamics in North America, potential Amitiza LOE in Japan, and approvals/launch uptake .

Estimates Context

Q3 2025 revenue: $3.76B vs consensus $3.60B*; beat by ~$0.16B*.
Q3 2025 EPS (normalized/primary): $0.67 vs consensus $0.62*; beat by ~$$0.05*.
EBITDA: S&P Global consensus $1.08B* vs S&P Global actual recorded $1.09B*; company‑reported adjusted EBITDA was $1.15B .
Values retrieved from S&P Global.*

Where estimates may adjust: Given guidance midpoint raises (revenue, adjusted EBITDA, adjusted EPS) and stronger Greater China/Emerging performance offsetting Indore, Street models likely lift FY topline and EPS, while incorporating Q4 seasonality and higher SG&A for launch prep .

Key Takeaways for Investors

Revenue and EPS beats paired with raised FY guidance midpoints support near‑term sentiment; expect Q4 seasonal step‑down but stable margins per management .
Indore headwinds are moderating and remediation is largely complete; penalties are not expected to recur in 2026, reducing a major overhang .
Pipeline catalysts in 2026: low‑dose estrogen patch (mid‑2026), fast‑acting meloxicam (pending NDA/label), and Japan CNS assets via Aculys—monitor labeling (opioid‑sparing) and early launch execution .
Geographic mix is improving: Greater China/Emerging strength offsets Developed/JANZ pressures; continued focus on complex generics and brand portfolios is a margin lever .
Capital return remains robust: $500M buybacks YTD and $0.12 dividend declared—management aims for long‑term balanced 50/50 capital deployment, with potential for accretive US innovative assets .
Strategic review could be a medium‑term re‑rating catalyst; quantification of multi‑year cost savings coming in Q1 2026 .
Watch Q4 phasing (revenues lower, SG&A up) and 2026 risks (North America competition, Amitiza LOE) when modeling trajectory .

Viatris Inc (VTRS)·Q3 2025 Earnings Summary