Viatris Inc. (Nasdaq: VTRS) reported its first quarter 2025 financial results on May 8, showing mixed performance as the company navigates industry volatility while advancing its pharmaceutical pipeline.
Financial Performance Reflects Operational Challenges
The global healthcare company reported total revenues of $3.3 billion for Q1 2025, representing an 11% decline on a reported basis and a 2% decrease on a divestiture-adjusted operational basis compared to the same period in 2024. This performance was primarily affected by what the company terms the "Indore Impact" – referring to negative consequences from an FDA warning letter and import alert related to Viatris' oral finished dose manufacturing facility in Indore, India. The company estimates this issue reduced Q1 revenues by approximately $140 million.
"2025 is off to a good start as we continue to focus on executing our strategic priorities," said Scott A. Smith, CEO of Viatris. "Our growing pipeline, capital discipline, operational execution, and significant global scope give us confidence in our ability to navigate the periods of increased volatility and uncertainty that our industry has been experiencing much of this year."
The most significant financial challenge came in the form of a $2.9 billion non-cash goodwill impairment charge, which drove the company's U.S. GAAP net loss to $3.0 billion, compared to net earnings of $114 million in Q1 2024. This resulted in a loss of $2.55 per share, compared to a gain of $0.09 per share in the prior-year period.
The impairment stemmed from what the company described as "a sharp and sustained decline in its share price and significantly increased uncertainty and volatility in the geopolitical and economic environments" since February 2025. These factors led to increased business risks, including potential drug pricing pressures, regulatory uncertainties with the FDA, and possible impacts from future tariffs and trade restrictions.
Despite these challenges, Viatris generated $535 million in U.S. GAAP net cash from operating activities and $493 million in free cash flow during the quarter.
Pipeline Progress Highlights Long-Term Strategy
A bright spot in Viatris' quarterly report was significant progress in its pharmaceutical pipeline, with three positive Phase 3 data readouts:
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The company received positive results from a Phase 3 open-label, long-term extension study for EFFEXOR® (venlafaxine hydrochloride) required for approval in Japan. Viatris has filed applications with Japan's Ministry of Health, Labor and Welfare for approval of EFFEXOR SR Capsules to treat adults with generalized anxiety disorder, an indication for which no other treatment option is currently approved in Japan.
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Viatris announced positive top-line results from two pivotal Phase 3 studies of its novel fast-acting formulation of meloxicam (MR-107A-02) for treating moderate-to-severe acute pain. The studies followed herniorrhaphy and bunionectomy surgeries, with all primary and secondary endpoints met, demonstrating statistically significant and clinically meaningful results. The company plans to submit a New Drug Application (NDA) to the FDA by the end of 2025.
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The company reported positive results from its Phase 3 study evaluating XULANE LO™, a low-dose weekly contraceptive dermal patch containing 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day. The study showed a favorable efficacy and safety profile with no new safety concerns, along with what the company describes as a potential best-in-class patch performance profile. Viatris plans to submit an NDA to the FDA in the second half of 2025.
The company generated approximately $67 million in new product revenues during the quarter and maintains its expectation to deliver between $450 million and $550 million in new product revenues throughout 2025.
Capital Allocation and Shareholder Returns
Viatris reaffirmed its commitment to prioritizing capital returns to shareholders in 2025. Year-to-date, the company has returned more than $450 million to shareholders, including over $300 million in share repurchases and approximately $143 million in dividends.
"We continue to generate strong cash flow and we are delivering on our capital allocation plan including share repurchases of over $300 million year to date," said Doretta Mistras, CFO of Viatris. "We believe we are currently well positioned to meet our financial guidance and our commitment to prioritizing returning capital to shareholders through the remainder of the year."
The company expects to execute $500 million to $650 million in total share repurchases in 2025 and plans to be opportunistic with available cash throughout the year. From a business development perspective, Viatris expects to continue pursuing regional licensing and partnership opportunities that provide immediate revenue contributions by leveraging its commercial and R&D infrastructure.
Segment Performance Shows Regional Variations
Viatris' performance varied across its global segments:
- Brands net sales reflected portfolio expansion in Emerging Markets and strong growth in Greater China and Developed Markets.
- Generics net sales were negatively impacted by the Indore facility issues but partially offset by growth in complex products in North America, strong performance across key European markets, and volume growth in JANZ (Japan, Australia, and New Zealand).
- Greater China was the only segment showing positive growth, with net sales increasing by 2% on a reported basis and 4% on a constant currency basis.
- Developed Markets, JANZ, and Emerging Markets all experienced double-digit percentage declines in net sales on a reported basis.
2025 Outlook Reaffirmed
Despite the Q1 challenges, Viatris reaffirmed its 2025 financial outlook, which was previously provided on February 27, 2025. The company expects:
- Total revenues between $13.5 billion and $14.0 billion
- Adjusted EBITDA between $3.89 billion and $4.19 billion
- Adjusted EPS between $2.16 and $2.30
- Free cash flow between $1.8 billion and $2.2 billion
U.S. GAAP net cash provided by operating activities for 2025 is estimated to be between $2.2 billion and $2.5 billion, with a midpoint of approximately $2.35 billion.
The company's ability to maintain its guidance despite the Q1 impairment charge and operational challenges suggests management's confidence in its underlying business fundamentals and strategic direction for the remainder of the year.
As Viatris navigates the volatile pharmaceutical landscape, its focus on pipeline development, operational efficiency, and shareholder returns will be crucial to overcoming the financial and regulatory challenges it currently faces.
