Viatris raises 2026 guidance, reports FDA approvals and Tyrvaya sale in Q2 update

Viatris reported second-quarter 2026 results on August 6, 2026, alongside several pipeline and regulatory updates. In July, the FDA approved Gwyn LoTM (norelgestromin and ethinyl estradiol transdermal system), a new combined hormonal contraceptive patch with low-dose estrogen¹, with the company expecting it to be commercially available later in 2026¹.

In August, Viatris signed a definitive agreement to sell the global product rights for Tyrvaya to Harrow, Inc. for an upfront payment of $30 million plus up to $70 million in commercial contingent milestone payments¹. The deal drove a quarterly non-cash charge tied to writing down the Tyrvaya intangible asset to fair value less cost to sell, contributing to the reported net loss.

Regulatory activity also included a June approval of a generic ferric carboxymaltose injection in three strengths, a substitutable version of Injectafer used for iron deficiency anemia and related conditions¹. Separately, in May the FDA accepted an application covering MR-107A-02, described as a fast-acting, non-opioid formulation of meloxicam for moderate-to-severe acute pain¹, with a PDUFA goal date set for December 27, 2026¹.

On manufacturing, the FDA inspected the company's Nashik, India oral solid dose facility in May and issued Form 483 observations; Viatris responded with a remediation plan involving outside experts, and while production has resumed, ongoing disruptions plus the earlier February fire are expected to cut second-half 2026 revenue by $100 million to $150 million¹.

On guidance, Viatris raised the midpoints of its 2026 financial guidance ranges¹, with total revenue guidance moving to a $14,550-$14,950 million range and adjusted EBITDA to $4,300-$4,500 million. The company also reported returning about $550 million to shareholders through August 5, including roughly $270 million in share repurchases, with about $730 million remaining under its buyback authorization¹.