Viatris Discloses Positive Data From 2 Drugs In Earnings Report, Stock Soars

Viatris Inc. VTRS on Thursday, released data from Phase 3 study evaluating the contraceptive efficacy and safety of XULANE LO low dose weekly dermal patch of 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day in women of childbearing potential.

In this study, XULANE LO demonstrated a favorable efficacy and safety profile; no new safety concerns were identified.

The study demonstrated contraceptive efficacy with a Pearl Index (PI) of 4.14. Additionally, the cumulative probability of pregnancy over 13 cycles was 3.7%.

A favorable safety and tolerability profile was observed, with most treatment-emergent adverse events (TEAEs) reported as mild to moderate. Favorable cycle control was also observed, with generally low unscheduled bleeding and spotting events.

Also Read: Viatris Agrees To $335 Million Opioid Settlement Framework

The study demonstrated a potential best-in-class patch adhesion profile with very few patches (1.3%) completely detaching over the seven-day wearing period and <1% of subjects reporting severe local application site reactions.

The company plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2025.

Viatris also shared results from its Phase 3 program of fast-acting formulation of meloxicam (MR-107A-02) for moderate-to-severe acute pain.

The Phase 3 program consisted of two trials: one following herniorrhaphy surgery and one following bunionectomy surgery.

The primary endpoint in both trials was defined by the Sum of Pain Intensity Difference (SPID) based on the Numeric Rating Scale measured over 0-48 hours (SPID0-48h).

In both studies, MR-107A-02 demonstrated statistically significant and clinically meaningful results. In particular:

• Treatment with MR-107A-02 led to improvement in pain versus baseline compared to placebo.
• MR-107A-02 demonstrated notable reduction in opioid usage over the entire treatment phase by reducing opioid use versus placebo and by showing a higher number of opioid-free patients than placebo (herniorrhaphy: 72.6% vs. 58.6%), and (bunionectomy: 56.9% vs. 33.1%).
• Post-hoc analyses demonstrated significantly superior pain control (SPID0-48) of MR-107A-02 versus the opioid arm in both surgical models. Significantly shorter time to perceptible and meaningful pain relief was observed for MR-107A-02 versus placebo and shorter or comparable to tramadol.
• MR-107A-02 was generally well tolerated.

The company aims to submit a New Drug Application to the U.S. Food and Drug Administration by the end of 2025.

Viatris reported first-quarter 2025 sales of $3.25 billion, almost in line with the consensus of $3.24 billion.

First quarter 2025 total revenues were $3.3 billion, down 11% on a reported basis and down 2% on a divestiture-adjusted operational basis compared to first quarter 2024, primarily driven by the negative Indore Impact.

Excluding the Indore Impact, total revenues would have increased 2% on a divestiture-adjusted operational basis compared to first quarter 2024.

In December 2024, the FDA issued a warning letter and an import alert related to the company’s oral finished dose manufacturing facility in Indore, India, which management estimates will reduce 2025 revenues by $500 million and adjusted EBITDA by $385 million.

For the first quarter of 2025, the estimated Indore Impact on total revenues was approximately $140 million.

The company generated approximately $67 million in new product revenues in the quarter and expects to deliver approximately $450 million to $550 million in new product revenues in 2025.

The company reported adjusted EPS of 50 cents, beating the consensus of 49 cents.

Guidance: Viatris reaffirmed its 2025 sales outlook of $13.5 billion—$14 billion, compared to the consensus of $13.82 billion.

The company raised 2025 adjusted EPS guidance from $2.12-$2.26 to $2.16-$2.30, versus the consensus of $2.21.

Price Action: VTRS stock is up 10.2% at $9.48 at last check on Thursday.

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