Summary of Viatris Conference Call Company Overview - Viatris operates as three distinct businesses: a global generics company, an established brands company, and an emerging innovative brands platform [2][3] - The company reported $14.1 billion in revenue, $4.1 billion in EBITDA, and $2.2 billion in free cash flow over the last 12 months [2] Key Financial Highlights - Viatris delivered $14.1 billion in revenue and $4.1 billion in EBITDA [2] - Achieved $2.32 in adjusted EBITDA and $2.2 billion in free cash flow [2] - The company operates in 165 countries with 1,400 unique products, serving over 1 billion people annually [3] Strategic Developments - The company advanced its pipeline with five positive phase 3 readouts out of six [4] - Significant progress was made with Cenerimod, Selatogrel, and Lucerastat in their phase 3 programs [4] - Over $1 billion was returned to shareholders through dividends and share buybacks [4] - Conducted 60 regional business development deals to support the base business, particularly in Japan [4][5] Future Outlook - Anticipated high-value product launches in 2026, including Sotagliflozin, Phentolamine, and Effexor GAD [6][7] - The company expects to generate significant cash flow in 2026, with plans for continued shareholder returns and growth asset development [9] - A strategic review is expected to yield substantial savings and reinvestment opportunities [22][24] Market Dynamics - The company is focusing on the U.S. market for high-margin revenue-generating assets, while also revitalizing its portfolio in Japan [36] - The competitive landscape is favorable for acquiring assets in the $500 million-$1 billion revenue range, with less competition for these assets [20][21] Pipeline and Product Development - Positive phase 3 results for Cenerimod and Selatogrel are expected to lead to significant market opportunities [51][60] - Fast-Acting Meloxicam is positioned to address the opioid crisis in pain management, with a strong market potential [43][45] - Selatogrel aims to revolutionize acute myocardial infarction management, with a large patient population and significant unmet need [60][62] Challenges and Risks - Pricing pressures and policy adjustments are anticipated in the JANS business, along with generic competition in Japan [29] - The Indore facility's remediation is nearing completion, with limited expected volatility in 2026 numbers [30][32] Capital Allocation Strategy - The company plans a balanced approach to capital allocation, focusing on shareholder returns and business development [34] - Expected free cash flow of over $2 billion annually for the next five years [33] Conclusion - Viatris is positioned for sustainable growth with a strong pipeline, strategic acquisitions, and a focus on enhancing its core business while navigating market challenges [12][15]

44th Annual J.P. Morgan Healthcare Conference January 13, 2026 1 Non-GAAP Financial Measures This presentation includes the presentation and discussion of certain financial information that differs from what is reported under accounting principles generally accepted in the United States ("U.S. GAAP"). These non-GAAP financial measures, including, but not limited to, adjusted EBITDA, free cash flow, free cash flow excluding transaction-related costs, and adjusted EPS, are presented in order to supplement inv ...

Core Insights - Viatris Inc. has announced four significant regulatory milestones in its global pipeline, highlighting advancements in research and development throughout 2025 [1][6][14] Group 1: Regulatory Approvals - The U.S. FDA has approved the company's octreotide acetate for injectable suspension, a generic version of Sandostatin LAR Depot, for treating acromegaly and certain cancer-related symptoms [6][14] - This approval marks the fourth injectable FDA approval for Viatris in 2025, alongside iron sucrose, paclitaxel, and liposomal amphotericin B, showcasing the company's ability to navigate complex regulatory pathways [3][14] - The FDA has accepted the New Drug Application (NDA) for a low dose estrogen weekly patch for contraception, with a target action date of July 30, 2026 [6][14] Group 2: Pipeline Developments - The investigational low dose estrogen weekly patch is designed for women with a BMI below 30 kg/m², delivering approximately 150 mcg of norelgestromin and 17.5 mcg of ethinyl estradiol per day [4][7] - The planned 505(b)(2) NDA for the patch is supported by positive results from the Phase 3 Luminous Study, demonstrating a favorable efficacy and safety profile [5][14] - The U.S. FDA has cleared the Investigational New Drug (IND) application for MR-146, a gene therapy candidate for neurotrophic keratopathy, with plans to initiate a Phase 1/2 clinical trial in the first half of 2026 [6][9][14] Group 3: International Developments - The Japan Pharmaceuticals and Medical Devices Agency has accepted the Japanese New Drug Application (J-NDA) for pitolisant in obstructive sleep apnea syndrome, supported by positive Phase 3 data [6][11][14] - The Phase 3 trial for pitolisant showed statistically significant improvements in excessive daytime sleepiness compared to placebo, indicating its potential effectiveness [11][14]

Summary of Viatris Conference Call Company Overview - **Company**: Viatris - **Business Segments**: - Global generics footprint (originating from Mylan) - Established products (notable brands include Lipitor, Norvasc, Xanax, Viagra, Celebrex from Upjohn acquisition) - Growing innovative segment [2][3] Core Points and Arguments - **Strategic Review**: Viatris is undergoing an enterprise-wide strategic review to assess its structure and cost efficiency, aiming for sustainable revenue and earnings growth beyond 2026 [4][20] - **Financial Performance**: - The company has returned over $1 billion to shareholders through dividends and share repurchases this year [3] - Anticipates approximately $500 million in new revenues annually from the base business, with a net growth of around $200 million after accounting for losses and price declines [8] - Internal expectations for revenue growth are higher than market estimates, with a goal to achieve continuous earnings growth over the next three to five years [7][26] - **Operating Leverage**: The company aims to improve operating leverage, targeting a growth profile shift from 1% to 3-5% [9][10] Pipeline and Product Development - **Innovative Assets**: Viatris is focusing on developing innovative products, including fast-acting meloxicam, which shows a faster onset of action compared to competitors [38][39] - **CNS Assets in Japan**: The acquisition of Aculys added CNS assets to Viatris' portfolio, with a strategic focus on growing revenues in the challenging Japanese market [32][34] - **Upcoming Launches**: The company is preparing for the launch of several products, including meloxicam and antiplatelet drugs, with significant market potential [46][63] Market Dynamics and Challenges - **External Challenges**: The company has faced external challenges such as tariffs, policy changes, and FDA regulations, which have impacted operations [2][3] - **Cost Structure Review**: Viatris is reviewing its cost structure post-merger and divestitures, aiming for significant cost savings while ensuring that these savings are sustainable [20][21] Investment and Capital Allocation - **Capital Deployment**: Viatris generates approximately $2 billion in free cash flow annually, with plans to allocate capital evenly between shareholder returns and business development [28][29] - **Focus on High-Margin Assets**: The company is looking to acquire high-margin, revenue-generating assets, particularly in the U.S. and Japan [35] Other Important Insights - **Market Positioning**: Viatris is positioning its innovative products as differentiated solutions in the market, with a focus on addressing unmet medical needs [39][63] - **Long-Term Vision**: The management emphasizes a long-term vision for growth, with a commitment to maintaining a strong base business while investing in innovation [6][26] This summary encapsulates the key points discussed during the Viatris conference call, highlighting the company's strategic direction, financial performance, product pipeline, and market challenges.

Financial Performance - Q3 2025 net product revenue reached $239.5 million, a 29% increase year-over-year compared to $186.0 million in Q3 2024[6, 36] - The company raised its full-year 2025 revenue guidance to $845 million - $865 million[6] - Non-GAAP adjusted net income increased by 11% from $57.3 million in Q3 2024 to $63.5 million in Q3 2025[36] - Cash, cash equivalents, and investments increased to $778.4 million in Q3 2025, a 54% increase compared to $504.7 million in Q3 2024[36, 38] WAKIX Performance - WAKIX average patients reached 8,100[11] - Approximately 500 average patient additions, representing the highest quarterly increase since launch[11] - Strong payer coverage of WAKIX at >80% of lives[11] Pipeline Development - The company plans to initiate Phase 3 registrational trials for Pitolisant HD in narcolepsy and IH in Q4 2025[20, 21] - Topline data from the pivotal bioequivalence study of Pitolisant GR is expected in Q4 2025[25, 33] - Phase 3 registrational trials are ongoing for EPX-100 in Dravet Syndrome (ARGUS study) and Lennox-Gastaut Syndrome (LIGHTHOUSE study), with topline data anticipated in 2026[19, 31, 33] - The Phase 3 RECONNECT study for ZYN002 in Fragile X Syndrome (FXS) did not meet the primary endpoint due to a higher-than-expected placebo response rate, and a review of the full data set is ongoing[19, 28]

Group 1 - Viatris Inc. has completed the acquisition of Aculys Pharma, a clinical-stage biopharmaceutical company, enhancing its growth potential [1][2] - The acquisition grants Viatris rights to develop and commercialize Pitolisant and Spydia, key assets in the Central Nervous System therapy area, along with rights for Spydia Nasal Spray in Japan and certain Asia-Pacific regions [2] - Truist initiated coverage of Viatris with a Buy rating and a $15 price target, citing positive changes under new leadership and a strong market position [3] Group 2 - Viatris is recognized as one of the best growth stocks under $25, indicating its potential for significant appreciation [1] - The company has a diverse portfolio of therapies across various therapeutic areas, which supports its market-leading position [3]

Financial Performance - Harmony Biosciences reported Q2 2025 net product revenue of $200.5 million, a 16% year-over-year increase compared to $172.8 million in Q2 2024 [8, 36] - The company's non-GAAP adjusted net income for Q2 2025 was $53.8 million, a 120% increase from $24.5 million in Q2 2024 [36] - Harmony Biosciences is confirming its full-year 2025 revenue guidance of $820 million to $860 million [8] - Cash, cash equivalents, and investments totaled $672.3 million as of Q2 2025, compared to $434.1 million in Q2 2024, a 55% increase [6, 38] WAKIX Performance - WAKIX is approaching blockbuster status, representing a $1 billion opportunity in narcolepsy alone [9] - The average patient count for WAKIX grew by approximately 400 to approximately 7,600 patients [8] - WAKIX has strong payer coverage of >80% of lives [8] Pipeline Development - Harmony Biosciences plans to initiate Phase 3 registrational trials for Pitolisant HD in narcolepsy and idiopathic hypersomnia (IH) in Q4 2025 [17, 29] - Topline data from the Phase 3 RECONNECT study of ZYN002 in Fragile X Syndrome (FXS) is expected in Q3 2025 [17, 18] - EPX-100 Phase 3 registrational trials are ongoing in Dravet syndrome (ARGUS study) & Lennox-Gastaut syndrome (LIGHTHOUSE study), with topline data anticipated in 2026 [17, 33]

Q1 2025 Financial Results & Business Update May 6, 2025 Copyright © 2025 Harmony Biosciences. All rights reserved. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2024 net product revenue, expectations for the gr ...

Financial Data and Key Metrics Changes - The company reported net product revenues of $714.7 million for 2024, representing a 23% year-over-year growth. In Q4 alone, net revenue was $201.3 million, reflecting a 20% increase from $168.4 million in the prior year quarter [11][25][55]. - Non-GAAP adjusted net income for Q4 2024 was $63 million, or $1.08 per diluted share, compared to $42.8 million or $0.73 per diluted share in the prior year quarter [56]. - The company ended Q4 with approximately $576 million in cash and cash equivalents, reflecting robust cash generation of approximately $219.8 million from operations in 2024 [55][57]. Business Line Data and Key Metrics Changes - The average number of patients on WAKIX increased to approximately 7,100 in Q4, with a sequential increase of about 300 patients from the previous quarter [25][26]. - The growth in WAKIX prescriptions was primarily driven by adult narcolepsy patients, constituting approximately 95% of the diagnosed narcolepsy opportunity [27]. Market Data and Key Metrics Changes - The company anticipates continued growth in WAKIX, with net revenue guidance for 2025 set at $820 million to $860 million, reflecting strong expectations for the year [58]. - The company is on track to achieve a $1 billion plus opportunity in narcolepsy alone, with a robust commercial infrastructure supporting this growth [30][31]. Company Strategy and Development Direction - The company aims to become a leading CNS company by advancing its late-stage pipeline to deliver one or more new product or indication launches each year [9]. - The strategic focus includes the development of next-generation formulations of pitolisant, such as pitolisant high-dose (HD) and pitolisant gas resistant (GR), to enhance patient care and extend revenue growth into the mid-2040s [31][40]. - The company is actively engaged in identifying additional opportunities to expand its leadership in Sleep/Wake, neurobehavioral disorders, and rare epilepsies [22]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth strategy, emphasizing that 2025 is shaping up to be a transformational year with key clinical milestones expected [17][62]. - The company remains committed to addressing unmet medical needs in idiopathic hypersomnia and narcolepsy, despite recent challenges with the supplemental new drug application for pitolisant in idiopathic hypersomnia [15][16]. Other Important Information - The company announced its first generic settlement agreement with Novagen Pharma, reinforcing the strength of its intellectual property portfolio [12][100]. - The company is on track to initiate pivotal Phase 3 registration trials for pitolisant HD in both narcolepsy and idiopathic hypersomnia in Q4 2025, with anticipated PDUFA dates in 2028 [40][41]. Q&A Session Summary Question: Can you provide updates on ZYN002 and the Phase 3 study? - Management expressed satisfaction with the ongoing trial and noted that they are enrolling patients aged three to 30 years, with a good proportion rolling over into the long-term extension study [66][71]. Question: Why should investors feel confident about Pitolisant HD's success in IH patients? - Management highlighted the evidence of efficacy from previous studies and the optimized formulation of pitolisant HD, which is expected to deliver larger efficacy for excessive daytime sleepiness and target symptoms like sleep inertia [76][79]. Question: How confident is the company in the timeline for Pitolisant HD trials given competition? - Management indicated confidence in the recruitment process due to established relationships with clinical trial sites and the robust signal shown in previous studies [84][88]. Question: What is the status of remaining patent challenges? - Management confirmed ongoing litigation processes and mentioned a Markman hearing scheduled for March, with a trial set for 2026 [96][99]. Question: What would success look like for the ZYN002 trial? - Success would be defined by demonstrating a statistically significant and clinically meaningful outcome on the primary endpoint, with supportive data from the previous CONNECT study [104][109].