Regarding selatogrel, at what point post-event are patients initiating oral antiplatelets, what is the off-time for platelet inhibition, and how is CABG handled in the trial?

Most patients are already on oral antiplatelet therapy. Selatogrel's effect is gone within 24 hours, allowing oral P2Y12 initiation. Peak platelet inhibition is reached in 6-7 hours. CABG can be initiated at any point if urgent, and safely after 8 hours post-injection. “within 6 to 7 hours, we get to peak platelet inhibition, 80% plated inhibition after 15 minutes or more than 80% after 15 minutes is what we've seen in Phase II. The offset is, as I said, within 24 hours, Seadrill is no longer present.”

Can you comment on FDA interactions regarding fast-acting meloxicam's opioid-sparing label, its long-term guidance impact, and for selatogrel, what minimum benefit is needed for meaningful uptake, and any subtleties for the composite endpoint?

Fast-acting meloxicam FDA review is mid-cycle, with label negotiations on opioid-sparing language expected in Oct/Nov. It could reach $500M in peak sales. For selatogrel, the study is powered for 20% risk reduction, but 10-15% benefit would drive meaningful uptake. The composite endpoint is ranked by clinical importance, expecting blunting of acute MI and reduced severity. “we could reach up to $500 million in peak sales with these assets and that will contribute meaningfully to our long-term guidance, both... The minimal bar is much lower than that in the mind of the investigators and KOL. I think if we were to be able to show is closer to 10% to 15%, that would be very much acceptable and the lowest bar commercially to get this drug to patients.”

Is the strength in China durable beyond 2026? Will Nashik disruptions be contained to 2026? And is the value-added pipeline still expected to contribute 1% to growth, or are expectations higher?

China's strength shows good durability, but policy changes could moderate growth; the impact is built into guidance. Nashik disruptions are expected to be short-term, mainly Q3/Q4 2026. The value-added pipeline, particularly fast-acting meloxicam, is seen as a significant contributor, with higher expectations than a 1% growth algorithm. “China seems to me to be a good engine for us moving forward. [...] we don't expect this to be long term affecting the business now. [...] we do see the impact being larger in Q3 and moderating a bit in Q4.”

VTRS

Viatris (VTRS) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 6, 2026

Source: earnings call transcript

Executive summary

Viatris Q2 FY26 — Strong Performance and Raised Full-Year Guidance

Viatris delivered a strong Q2 FY26, exceeding expectations with robust operational revenue growth and improved operating leverage, leading to a raise in full-year guidance across all key financial metrics. The company is prioritizing capital and resources towards long-term growth opportunities, advancing its pipeline with key regulatory approvals and clinical milestones, while also returning capital to shareholders and maintaining a disciplined approach to business development.

Highlights

Delivered $3.8 billion in total revenues, representing 3.5% operational growth year-over-year.
Achieved adjusted EBITDA of $1.2 billion and adjusted EPS of $0.69 per share, exceeding expectations.
Raised the midpoint of 2026 financial guidance across all key metrics (revenue, EBITDA, EPS).
Greater China net sales increased 16% year-over-year, driven by strategic investments and favorable market fundamentals.
Received U.S. regulatory approval for Winland, a new transdermal hormonal contraceptive patch, ahead of its PDUFA date.
Returned approximately $550 million to shareholders through dividends and share repurchases, and repaid $900 million of debt.

Concerns

Nashik facility manufacturing disruptions and FDA inspection observations are expected to impact H2 revenues by $100 million to $150 million.
Greater China growth is expected to moderate in the second half due to a procurement policy change negatively impacting hospital channel volumes.
Net sales in Emerging Markets declined 2% year-over-year, falling below expectations due to supply constraints in the ARV generics portfolio.
The company agreed to sell the global rights to Tirva, signaling a strategic shift away from eye care as a therapeutic area of focus.
Additional competitive pressure is anticipated in developed markets for Brena and Wixela in North America.

Guidance & targets

Category	Target	Timeline	Confidence
Full-year 2026 Total Revenues Operational Growth	approximately 2% high materiality	FY26	High
Full-year 2026 Adjusted EBITDA Operational Growth	approximately 5% high materiality	FY26	High
Full-year 2026 Adjusted EPS Operational Growth	approximately 7% high materiality	FY26	High
Full-year 2026 Total Revenues Growth - Greater China	Low double-digit growth medium materiality	FY26	High
Full-year 2026 Total Revenues Growth - Developed Markets	roughly flat medium materiality	FY26	High
Full-year 2026 Total Revenues Growth - North America	declining slightly medium materiality	FY26	High
Full-year 2026 Total Revenues Growth - Emerging Markets	low single-digit growth medium materiality	FY26	High
Full-year 2026 Total Revenues Growth - Jans	low single-digit decline medium materiality	FY26	High
Nashik Facility Supply Disruptions Impact on H2 2026 Total Revenues	$100 million and $150 million medium materiality	H2 FY26	High
Full-year 2026 Total Revenues Weighting	approximately 51% low materiality	H2 FY26	High
Full-year 2026 Adjusted EBITDA Weighting	slightly lower in the second half low materiality	H2 FY26	High
Full-year 2026 Adjusted EPS Weighting	slightly lower in the second half low materiality	H2 FY26	High
Full-year 2026 Free Cash Flow Weighting	more heavily weighted to the second half low materiality	H2 FY26	High
Nefecon NDA Submission in Japan	by the end of 2026 medium materiality	FY26	High
Pitolisant Regulatory Decisions in Japan	in the second half of this year medium materiality	H2 FY26	High
Progestin-only Patch Top-line Results	in the first half of 2027 medium materiality	H1 FY27	High
Cenerimod Phase III SLE Studies Results	in the first half of 2027 high materiality	H1 FY27	High
Selatogrel Phase III SOS Study Data Readout	in the first half of 2027 high materiality	H1 FY27	High
Generic Pipeline New Product Approvals	more than 100 new product approvals this year medium materiality	FY26	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
Developed Markets Net sales increased by 2% versus the prior year, exceeding expectations.	—	2%	—	—
North America Net sales grew 1%, driven by increased demand across the diverse generics portfolio and strength from Brain. New product revenues benefited from complex injectables. Net sales growth: 1%Drivers: increased demand across diverse generics portfolio (including estradiol patches), continued strength from Brain, momentum in complex injectable portfolio (octreotide, iron sucrose)Branded product performance: YUPELRI solid growth offset by anticipated competitive pressure on established brands	—	1%	—	—
Europe Net sales increased 2% versus the prior year, primarily driven by strength in the generics portfolio and new product revenues. Net sales growth: 2%Drivers: strength in generics portfolio across key countries (France, Italy), contributions from new product revenuesBranded product performance: solid growth from Creon and Brufen offset by anticipated competitive pressure on dimes stock	—	2%	—	—
Emerging Markets Net sales declined 2% versus the prior year, coming in below expectations, primarily due to supply constraints in the ARV generics portfolio. Net sales decline: 2%Drivers: continued supply constraints affecting lower-margin ARV generics portfolioBranded product performance: net sales increased 6% year-over-year, supported by stable growth across established brands	—	-2%	—	—
Jans Net sales were essentially flat versus the prior year, exceeding expectations, reflecting new product uptake and generics volume growth, offset by price regulations and competition. Net sales growth: essentially flatDrivers: uptake from launch of effector for generalized anxiety disorder, broad volume growth in genericsHeadwinds: anticipated impact of government-driven price regulations in Japan, increased competition for certain brands in Australia	—	flat	—	—
Greater China Delivered another exceptional quarter with net sales increasing 16% year-over-year, ahead of expectations, benefiting from favorable market fundamentals and strategic investments. Net sales growth: 16%Drivers: favorable market fundamentals (aging population, demand for cardiovascular products), strategic investments in selling and marketing capabilities (e-commerce, retail platforms)E-commerce sales growth: 36%	—	16%	—	—

Deals & partnerships

Undisclosed Sale of global rights to Tirva

Agreed to sell the global rights to Tirva, reflecting a strategic shift away from eye care as a therapeutic area of focus. Transaction expected to close in H2 2026, subject to customary closing conditions.

Risks & headwinds

Nashik facility manufacturing disruptions and FDA inspection observations second half of 2026

$100 million and $150 million impact to total revenues

Mitigation:communicating with FDA, working closely with external experts, initiated comprehensive remediation plan; impact expected to be short-term and intermittent, larger in Q3 and moderating in Q4

Moderation in Greater China growth due to procurement policy change second half of 2026

expected to negatively impact volumes in hospital channel

Mitigation:built into forecast; overall growth expected to continue but muted; active discussions with government to understand policy execution; will have better view by November

Additional competitive pressure in developed markets second half of 2026

impact on Brena and Wixela in North America

Mitigation:fully considered in updated 2026 financial guidance

Supply constraints affecting ARV generics portfolio Q2 FY26 and ongoing

Emerging Markets net sales declined 2% year-over-year

Mitigation:not explicitly stated, but company is working to ramp up production for other high-demand products like estradiol patches

What to watch in Q3 FY26

Fast-acting meloxicam FDA label negotiations

October/November 2026

Current FDA review progressing, mid-cycle point reached

Target Clarity on opioid-sparing language in label

Why it matters

The specific language around opioid sparing will be crucial for the commercial positioning and market potential of this asset.

labeling negotiations won't start until October, November time frame. So this is when really we'll start talking about the exact language around opioid sparing.

Find out whether VTRS delivers this. Inve re-checks your case every morning.

Q&A highlights

Can you provide a breakdown of China revenue by channel (e-commerce, retail, hospital) and explain why the EBITDA guidance raise is double the revenue raise at the midpoint?

E-commerce accounts for 10-15% of China's business, with growth across all channels. The higher EBITDA raise is due to strong cost containment measures being ahead of schedule, offsetting challenges from high-margin product competition and lower-margin Nashik disruptions in H2.

“e-commerce is about 10 -- between 10% and 15% of the overall business. [...] Adjusted EBITDA was approximately twice the growth or the increasing expectation over revenue, right? And a lot of that is because of the cost containment measures are on track and even ahead of schedule in certain instances.”

asked by Ashwani Verma · answered by Paul Campbell

2 min read 6 chapters

Detailed narrative

Strong Q2 Performance and Raised Outlook

Viatris delivered an exceptional Q2 FY26, with total revenues of $3.8 billion, marking 3.5% operational growth year-over-year. Adjusted EBITDA reached $1.2 billion and adjusted EPS was $0.69 per share, both exceeding expectations. This strong performance, driven by momentum across businesses and improved operating leverage, led the company to raise the midpoint of its 2026 financial guidance across all key metrics, including 2% operational growth for total revenues, 5% for adjusted EBITDA, and 7% for adjusted EPS.

Pipeline Progress and Key Milestones

The company's pipeline is progressing as expected, with several significant milestones achieved or anticipated. U.S. regulatory approval was received for Winland, a new transdermal hormonal contraceptive patch, with launch expected later this year. Fast-acting meloxicam is progressing through FDA review with anticipated approval towards year-end, and Nefecon showed positive Phase III results in Japan, targeting NDA submission by end of 2026.

Additionally, regulatory decisions for pitolisant in Japan are expected in H2 2026, and Phase III readouts for cenerimod and selatogrel are on track for H1 2027, representing potential blockbuster opportunities.

Strategic Review and Operating Leverage

Viatris's enterprise-wide strategic review is yielding committed savings, which are being reinvested to support future growth. This has translated into real operating leverage, contributing to the strong financial performance. The company noted that cost containment measures are on track and even ahead of schedule in certain instances, driving adjusted EBITDA growth that outpaced revenue growth in the first half of the year.

Capital Allocation and Balance Sheet Strength

The company continues its balanced and opportunistic capital allocation strategy, supported by strong cash generation and financial flexibility from the Biocon equity stake monetization. Through early August, Viatris deployed approximately $1.4 billion of capital, including returning $550 million to shareholders via dividends and share repurchases, and repaying $900 million of debt.

This resulted in a gross leverage ratio of approximately 2.9x, below the midpoint of its long-term target range of 2.8x to 3.2x.

Greater China Momentum and Policy Headwinds

Greater China delivered another exceptional quarter with net sales increasing 16% year-over-year, exceeding expectations. This growth was driven by favorable market fundamentals, strategic investments in selling and marketing capabilities, and strong e-commerce performance, which saw sales increase 36% YoY. However, the company anticipates moderation in Greater China growth in the second half due to the implementation of a procurement policy change expected to negatively impact volumes in the hospital channel, though overall growth is still expected.

Nashik Facility Disruptions and Remediation

The company experienced intermittent manufacturing disruptions at its Nashik facility following a fire and FDA inspection observations in May 2026. These issues are expected to impact total revenues by $100 million to $150 million in the second half of 2026, primarily affecting low-margin oral solid dose generics.

Viatris is communicating with the FDA, working with external experts, and has initiated a comprehensive remediation plan, expecting the impact to be short-term and largely contained to 2026.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.