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Viatris (VTRS)

Earnings summaries and quarterly performance for Viatris.

Recent press releases and 8-K filings for VTRS.

Viatris provides pipeline update on four regulatory milestones
VTRS
Product Launch
New Projects/Investments
  • FDA approval of generic octreotide acetate LAR depot injectable suspension for acromegaly and carcinoid tumour indications
  • FDA acceptance of NDA for a once-weekly low-dose estrogen patch (150 mcg norelgestromin/17.5 mcg ethinyl estradiol) with a PDUFA target date of July 30, 2026
  • FDA clearance of IND for MR-146 AAV gene therapy in neurotrophic keratopathy, with a Phase 1/2 CORVITA trial planned in H1 2026
  • PMDA acceptance of J-NDA for pitolisant in obstructive sleep apnea syndrome; narcolepsy J-NDA submission expected by year-end 2025
2 days ago
Viatris announces monetization of Biocon Biologics stake
VTRS
M&A
  • Viatris will sell its convertible preferred equity in Biocon Biologics for $815 million total consideration: $400 million in cash and $415 million in newly issued Biocon Limited shares.
  • The agreement accelerates biosimilars non-compete restrictions, which will lapse immediately for ex-U.S. markets and in November 2026 for U.S. markets.
  • The transaction is expected to close in Q1 2026, subject to customary closing conditions.
  • Citi is acting as financial advisor, with Cravath, Swaine & Moore LLP and Khaitan & Co. as legal advisors to Viatris.
Dec 8, 2025, 12:00 PM
Viatris to monetize Biocon Biologics stake
VTRS
M&A
Convertible Preferred Issuance
  • Viatris enters agreements to sell its convertible preferred equity stake in Biocon Biologics for $815 million total consideration ($400 million cash + $415 million Biocon shares).
  • Shares are subject to a six-month lock-up and will trade on the National Stock Exchange of India.
  • The deal accelerates expiration of biosimilars non-compete restrictions, effective at close outside the U.S. and in November 2026 for U.S. markets.
  • The transaction is expected to close in Q1 2026, pending satisfaction of closing conditions.
Dec 6, 2025, 2:00 PM
Viatris outlines strategic review and growth plan at Evercore HealthCONx Conference
VTRS
Guidance Update
New Projects/Investments
  • Viatris is executing an enterprise-wide strategic review to optimize cost structure and position for sustained revenue and earnings growth beyond 2026.
  • The company expects its base business to generate approximately $200 million of net annual growth, supplemented by innovative assets from its pipeline and M&A activity.
  • Over a three-year period, Viatris aims to capture significant, sticky cost savings—after allowing for reinvestment—with the majority flowing through to the bottom line.
  • It plans to deploy about $2 billion in annual free cash flow equally between shareholder returns (dividends and buybacks) and building its growth pipeline.
  • Key pipeline highlights include fast-acting meloxicam for acute pain with an opioid-sparing claim expected, and on-demand antiplatelet selatogrel for acute MI, both in late-stage development and targeted for launch in late 2026.
Dec 3, 2025, 1:45 PM
Viatris outlines strategic review and growth drivers at HealthCONx Conference
VTRS
Guidance Update
New Projects/Investments
  • Viatris is organized into a global generics business, an established products segment (e.g., Lipitor, Norvasc), and an innovative pipeline, with five of six Phase 3 readouts positive in 2025.
  • Returned over $1 billion to shareholders in 2025 via dividends and share repurchases; plans to allocate ~50% of $2 billion annual free cash flow to returns over the next 3–5 years.
  • Initiated an enterprise-wide strategic review to realize multiyear cost savings, reinvest in new product launches, and drive sustained revenue and earnings growth from 2026 onward.
  • Acquired Aculys-Japan assets (Pitolisant and Speedia) to leverage existing CNS infrastructure and reverse revenue declines in the Japanese market.
  • Key upcoming catalysts include the PDUFA submission for fast-acting meloxicam (launch toward end of 2026), and Phase 3 readouts for selatogrel and cenerimod in late 2026.
Dec 3, 2025, 1:45 PM
Viatris outlines strategy for sustained revenue and earnings growth
VTRS
  • Viatris is organized into three separate businesses—global generics, established Upjohn brands, and a growing innovative segment—and has launched an enterprise-wide strategic review to position for sustained revenue and earnings growth from 2026 onward.
  • The base generics and established products business is expected to generate approximately $500 million in new annual revenues, absorb $300 million in losses and price declines, and still yield a net $200 million of sustainable yearly growth.
  • An ongoing three-year cost-reduction program aims to deliver significant, sticky savings, with the majority flowing to the bottom line after partial reinvestment in new product launches.
  • Viatris generates about $2 billion of free cash flow annually, deploying it roughly 50/50 between shareholder returns (dividends and buybacks) and investing in its pipeline and in-market acquisitions.
  • Key pipeline catalysts include a late-2026 launch of fast-acting meloxicam with a 45-minute onset and opioid-sparing claim , the self-administered selatogrel Phase 3 program for acute MI , and two Phase 3 trials of cenerimod in lupus.
Dec 3, 2025, 1:45 PM
Versanis details capital strategy and pipeline updates at Piper Sandler Healthcare Conference
VTRS
  • Versanis aims for a 50/50 split over 3–5 years between capital deployment (business development) and capital return, leaning into share buybacks this year amid favorable stock performance.
  • Cenerimod’s Phase III SLE program (OPUS-2 fully enrolled) and a parallel lupus nephritis Phase III program are advancing on plan, targeting oral once-daily add-on therapy data in 2026.
  • Selatogrel Phase III enrollment has accelerated to ~1,000 patients/month, with full enrollment expected by year-end and top-line results anticipated in late 2026/early 2027.
  • A pre-NDA meeting for fast-acting meloxicam is scheduled, with potential for an accelerated review; commercialization will focus on outpatient and in-office acute pain settings.
  • An enterprise-wide strategic review of commercial, R&D, manufacturing, and corporate functions is underway to deliver multi-year net savings and fund growth, with results due early 2026.
Dec 2, 2025, 1:30 PM
Viatris outlines capital strategy, pipeline progress, and cost review
VTRS
Share Buyback
Product Launch
  • Viatris targets a 50/50 split over a 3–5-year horizon between capital return (notably share buybacks this year) and business development, with a focus on U.S. branded, higher-margin assets.
  • Cenerimod’s Phase III SLE trials (OPUS-2 fully enrolled; OPUS-1 starting soon) and new Phase III lupus nephritis program leverage its oral, once-daily profile and demonstrated PK in renal impairment.
  • Selatogrel’s global Phase III acute MI study is enrolling ~1,000 patients/month, on track for full enrollment by year-end, with top-line results expected late 2026/early 2027; rival zalunfiban data bolster its 21% risk-reduction goal.
  • Fast-acting meloxicam (505(b)(2)) is gearing up for an NDA pre-meeting with FDA imminently, aiming for accelerated review, targeting outpatient and office-based acute pain, and at least 3 years exclusivity plus pending patent extensions.
  • An enterprise-wide strategic review across commercial, R&D, manufacturing, and corporate functions seeks multi-year net savings to reinvest in sustainable revenue and EBITDA growth, with outcomes due early next year.
Dec 2, 2025, 1:30 PM
Viatris outlines balanced capital allocation and advances pipeline at Piper Sandler Healthcare Conference
VTRS
Share Buyback
M&A
  • Maintains a 50/50 capital allocation between deployment and shareholder returns, prioritizing share buybacks this year given operational context.
  • Pursuing commercial-stage branded, patent-protected assets, highlighted by the Aculys Pharma transaction adding Pitolisant and Sunosi in Japan.
  • Cenerimod: two Phase III SLE trials (OPUS-2 fully enrolled, OPUS-1 upcoming) and new Phase III lupus nephritis program; Selatogrel Phase III acute MI trial nearing full enrollment with top-line data expected late 2026/early 2027.
  • Pre-NDA meeting planned for fast-acting meloxicam, focusing on outpatient and in-office acute pain, with at least 3 years exclusivity under 505(b)(2) and potential extensions.
  • An enterprise-wide strategic review is ongoing to identify multi-year net savings across commercial, R&D, manufacturing, and support functions, with results due early next year.
Dec 2, 2025, 1:30 PM
Viatris outlines 2025 progress, strategic review and 2026 outlook at Jefferies Conference
VTRS
Share Buyback
Dividends
Guidance Update
  • 2025 performance: Viatris delivered five positive Phase III readouts out of six and achieved strong commercial execution across geographies; returned ~$500 million in share buybacks year-to-date and expects to exceed $1 billion in total capital returns (dividends + buybacks) during 2025.
  • Enterprise-wide strategic review: Five years post-merger, management is conducting a deep cost and organizational assessment across sales, R&D, manufacturing and support functions, targeting meaningful savings (majority to bottom line, with a portion reinvested).
  • Manufacturing facility update: Indoor plant remediation is > 90% complete; FDA will conduct a surprise reinspection—likely in H1 2026—with the goal of a non-event from a financial and supply-chain perspective.
  • Pipeline & 2026 guidance: The company expects $450 million–$550 million in new product revenue in 2026 from complex generics (e.g., octreotide) excluding fast-acting meloxicam and Xulane ; fast-acting meloxicam NDA to be filed by year-end for 2026 launch, differentiated by a 45-minute T_max and opioid-sparing effect.
  • Balanced capital allocation: Strategy emphasizes a mix of dividends, share buybacks and business development for in-market, accretive assets, leveraging Viatris’s 165-country footprint (notably recent Japanese acquisitions).
Nov 18, 2025, 11:30 AM