CLASS PERIOD: August 8, 2024 to February 26, 2025 ALLEGATIONS: According to the complaint, defendants provided investors with material information concerning the failed inspection of Viatris' Indore, India facility. Defendants' statements misrepresented the FDA's issuance of a warning letter and its impact on Viatris' operations. Defendants routinely referred to the impact of the warning letter as a mere "minor headwind" for the Company. On February 27, 2025, Viatris announced its financial results for the ...

PITTSBURGH, April 21, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced it has filed applications to the Ministry of Health, Labor and Welfare (MHLW) for approval of Effexor SR Capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI) to treat adults with generalized anxiety disorder (GAD), an indication for which no other treatment option is currently approved in Japan. As previously announced, our Phase 3 placebo-controlled, rand ...

NEW YORK, April 21, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Viatris Inc. (NASDAQ: VTRS). Shareholders who purchased shares of VTRS during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: The Gross Law Firm 15 West 38th Street, 12th floor New York, NY, 10018 Email: [email protected] Phone: (646) 453-8903 SOURCE The G ...

Market Overview - Major U.S. equities indexes experienced declines as investors reacted to new tariff announcements and a drop in Nvidia shares, which fell 8.5% despite solid earnings [1] - The S&P 500 decreased by 1.6%, while the Nasdaq fell 2.8% due to weakness in technology stocks, and the Dow Jones Industrial Average ended 0.5% lower [2] Company-Specific Developments - Teleflex (TFX) shares dropped 21.7% after announcing plans to split into two companies [2] - Super Micro Computer (SMCI) fell 16% following reports of two officers filing to sell shares, alongside a delayed annual report [3] - Viatris (VTRS) stock declined by 15.2% due to weaker-than-expected earnings and a disappointing outlook, impacted by regulatory actions affecting profits [3] - Vistra Corp. (VST) shares decreased by 12.3% despite better-than-expected earnings, as other AI-related stocks also lost ground [4] - Invitation Homes (INVH) stock rose by 5.5% after reporting quarterly revenue and net income that exceeded analyst estimates [5] - Warner Bros. Discovery (WBD) shares increased by 4.7% after reporting weaker-than-expected earnings but providing a positive streaming outlook [6] - Allstate (ALL) shares rose 3.5% following the announcement of a dividend increase and a $1.5 billion share buyback program [6] - Universal Health Services (UHS) saw a 3.3% increase in shares after reporting better-than-expected earnings and a positive revenue outlook [7]

Viatris reported mixed results for Q4 2024, missing revenue and EPS expectations, despite noteworthy debt reduction and portfolio adjustments.Viatris (VTRS -15.61%), a global healthcare company known for its broad portfolio of pharmaceutical products, released its fourth-quarter 2024 results on Feb. 27. Despite achieving substantial debt reduction and strategic advancements, Viatris fell short of analysts' forecasts. The adjusted earnings per share (EPS) stood at $0.54, missing the estimated $0.56, while to ...

Financial Performance - Theravance Biopharma reported a fourth-quarter 2024 adjusted net loss of 5 cents per share, consistent with the Zacks Consensus Estimate, compared to earnings of 3 cents per share in the same quarter last year [1] - Total revenues for the quarter were $18.8 million, slightly exceeding the Zacks Consensus Estimate of $18.0 million, and reflecting a year-over-year increase of 6.8% due to higher collaboration revenues from partner Viatris [3] - The reported loss, including share-based compensation, income tax expense, and non-cash interest expense, was 31 cents per share, compared to a loss of 17 cents in the year-ago quarter [2] Collaboration and Revenue Sources - The revenue was entirely derived from Viatris' collaboration revenues related to Yupelri (revefenacin) sales, which increased by 8% year over year in the fourth quarter [4] - Viatris recorded U.S. net sales of Yupelri at $66.7 million, marking a 10% year-over-year increase [6] - Viatris retains 65% of the profits from Yupelri sales, while Theravance receives 35%, which includes its share of net sales and proportionate costs [5] Expenses and Financial Guidance - Research and development expenses (excluding share-based compensation) totaled $8.1 million, up nearly 23% from the previous year, while selling, general, and administrative expenses increased around 23% year over year to $14.1 million [9] - For 2025, Theravance expects adjusted R&D expenses to be in the range of $32-$38 million and adjusted SG&A expenses between $50 million and $60 million, with share-based compensation expenses projected at $18-$20 million [12] Cash Position and Future Outlook - As of December 31, 2024, Theravance had cash, cash equivalents, and marketable securities amounting to $88.4 million, down from $91.4 million as of September 30, 2024 [11] - The company anticipates adjusted losses and cash burn in 2025 to be similar to 2024 levels, with an adjusted loss of $16 million and cash burn of $14 million recorded in 2024 [13] Pipeline Developments - Theravance is developing ampreloxetine (TD-9855), a norepinephrine reuptake inhibitor for treating neurogenic orthostatic hypotension in patients with multiple system atrophy [14] - The phase III CYPRESS study for ampreloxetine was initiated in 2024, with patient enrollment expected to complete by mid-2025, and top-line data anticipated six months post-enrollment [15]

Financial Data and Key Metrics Changes - In Q4 2024, YUPELRI net sales increased by 10% year-over-year, reaching $66.7 million, marking an all-time high [4] - Full year YUPELRI sales totaled $239 million, with an 8% increase in net sales for 2024 and an 11% growth in demand [11][14] - Collaboration revenue grew by 8% to approximately $19 million in Q4 [32] - Operating expenses, excluding share-based compensation, increased to $22 million due to higher commercial and medical affairs spending [32] Business Line Data and Key Metrics Changes - YUPELRI's hospital performance saw doses increase by 49% year-over-year, with 285,000 redoses pulled through to hospital customers [4][13] - The hospital business accounts for roughly 10% of total YUPELRI volume, with 90% coming from community settings [77] - Ample enrollment in the CYPRESS study for ampreloxetine is on track, with expectations for expedited NDA filing [5][20] Market Data and Key Metrics Changes - TRELEGY reported full year sales of $3.5 billion, up 26% year-over-year, triggering a $50 million milestone payment [15] - The company anticipates achieving an additional $150 million in milestones from TRELEGY in 2025 and 2026 [16] Company Strategy and Development Direction - The company aims to grow YUPELRI revenue while increasing brand profitability, with potential near-term sales milestones in the U.S. and royalties from China [7] - For ampreloxetine, the focus is on completing enrollment in the CYPRESS study and preparing for an expedited NDA filing [8] - The company is committed to maximizing the value of TRELEGY and returning excess capital to shareholders [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the financial position entering 2025, with $88 million in cash and no debt [39] - The company is focused on driving YUPELRI growth through strong demand generation and a patient-centered strategy [40] - Management highlighted the potential impact of ampreloxetine on patients with MSA suffering from nOH symptoms [41] Other Important Information - The company completed market research indicating a significant unmet need for better nOH therapies, with over 70% of surveyed neurologists agreeing [25] - The target product profile for ampreloxetine aligns with physician preferences, suggesting a favorable outlook if approved [28] Q&A Session Summary Question: What drove the success in the hospital channel this quarter? - The success was attributed to effective execution of strategy and wins in larger systems, with therapeutic interchange contributing to increased volume [45][46] Question: What is the trend for the hospital performance into 2025? - Q1 is typically softer, but there is a demonstrated need for YUPELRI, which may provide a tailwind [60] Question: What are the next steps for YUPELRI in China? - The company is waiting for regulatory feedback from Viatris, with a typical two-year window expected from submission to approval [62] Question: What was the nature of the recent FDA feedback on ampreloxetine? - The feedback was from a Type C meeting to clarify filing content and ensure alignment on key requirements for full approval [67] Question: What percentage of YUPELRI sales are non-hospital sales? - The hospital business accounts for roughly 10% of total YUPELRI volume, with the community setting making up the majority [77] Question: What is the bar for success for the CYPRESS readout? - A one-point change in the OHSA composite score is considered clinically meaningful for success [88]

Core Insights - Theravance Biopharma reported strong financial and operational results for Q4 and FY 2024, highlighting record net sales for YUPELRI and significant milestones related to TRELEGY [2][4][5] Financial Performance - Q4 2024 US net sales for YUPELRI reached $66.7 million, a 10% increase year-over-year, while FY 2024 total US net sales were $238.6 million, up 8% compared to 2023 [4][5] - Global net sales for TRELEGY in Q4 2024 were $853 million, marking a 16% increase, and $3.46 billion for FY 2024, a 26% increase year-over-year, triggering a $50 million milestone payment to Theravance Biopharma [3][4][5] - Total revenue for Q4 2024 was $18.8 million, entirely from Viatris collaboration revenue, which increased by 8% compared to Q4 2023 [9] Research and Development - R&D expenses for Q4 2024 were $9.5 million, compared to $8.3 million in Q4 2023, with full-year R&D expenses of $32.5 million falling within the guidance range [9][10] - The CYPRESS study is on track to enroll the final patient by mid-2025, with top-line data expected approximately six months later [4][5] Strategic Initiatives - The company formed a Strategic Review Committee to explore alternatives for unlocking shareholder value [7] - Theravance Biopharma is preparing for an expedited NDA filing post-CYPRESS readout and has received confirmation from the FDA regarding the content of a complete application [5][10] Market Position and Future Outlook - The company anticipates continued growth in YUPELRI sales, with a potential $25 million milestone payment from Viatris if YUPELRI achieves at least $250 million in US net sales in 2025 [5][10] - Royalties of up to 8.5% on TRELEGY net sales will return to Theravance Biopharma in eligible territories starting mid-2029, contributing to long-term value [5][10]

Key Points Company Overview 1. **Company Name and Stock Symbol**: Viatris Inc. (NASDAQ: VTRS) 2. **Event**: 43rd Annual J.P. Morgan Healthcare Conference 2025 3. **Date and Time**: January 14, 2025, 11:15 AM ET 4. **Participants**: - Scott Smith - CEO - Doretta Mistras - CFO - Philippe Martin - Chief R&D Officer - Corinne Le Goff - Chief Commercial Officer - Chris Schott - JPMorgan [1] Forward-Looking Statement 1. **No Guidance Provided**: The company will not be commenting on the full year 2024 or providing guidance for 2025 during the presentation. [2] Financial Highlights 1. **Revenue**: $15 billion in the last 12 months 2. **Adjusted EBITDA**: $4.8 billion in the last 12 months 3. **Free Cash Flow**: $2.4 billion in the last 12 months 4. **Financial Strength**: Viatris demonstrates tremendous financial strength [3] Business Segments 1. **Global Generics Business**: Strong global generics business 2. **Iconic Brands**: Home to iconic brands in the pharma world, including Lipitor, Lyrica, Celebrex, Norvasc, Viagra, etc. [3] Geographic Presence 1. **Global Operations**: Operates in 165 countries around the world [4]

Viatris Inc. (NASDAQ:VTRS) Jefferies 2024 Global Healthcare Conference Call June 6, 2024 8:00 AM ET Company Participants Scott Smith - Chief Executive Officer Doretta Mistras - Chief Financial Officer Philippe Martin - Chief R&D Officer Conference Call Participants Glen Santangelo - Jefferies Glen Santangelo All right. Well, good morning, everybody. Thank you for joining this early. We're excited to get Day 3 going to the Jefferies Healthcare Conference. For our next presentation, we're excited to have Viat ...