For Hetlioz, full-year net product sales fell 7% to $71.4 million. Moran said the decline reflected lower volume and price net of deductions amid continued U.S. generic competition, while noting the brand “continued to retain the majority of market share despite generic competition now for over three years.” Ponvory net product sales were $27.4 million, down 2% versus 2024, with the company also noting that certain variable consideration tied to Ponvory sales remains subject to dispute.Total 2025 revenues a ...

Financial Data and Key Metrics Changes - Total revenues for the full year 2025 were $216.1 million, a 9% increase compared to $198.8 million for 2024 [18] - Net loss for the full year 2025 was $220.5 million, compared to a net loss of $18.9 million for 2024, primarily due to a one-time, non-cash income tax charge [21][22] - Operating expenses for the full year 2025 were $367.3 million, an increase from $239.4 million in 2024 [24] Business Line Data and Key Metrics Changes - Fanapt net product sales were $117.3 million for 2025, a 24% increase from $94.3 million in 2024, driven by a 28% rise in total prescriptions and a 149% surge in new-to-brand prescriptions [5][19] - Hetlioz net product sales were $71.4 million for 2025, a 7% decrease from $76.7 million in 2024, impacted by generic competition [20] - Ponvory net product sales were $27.4 million for 2025, a 2% decrease from $27.8 million in 2024 [21] Market Data and Key Metrics Changes - Fanapt was one of the fastest-growing atypical antipsychotics in the market throughout 2025, with total prescriptions increasing by 36% in Q4 2025 compared to Q4 2024 [37] - The total addressable market for the antipsychotic category was estimated at approximately $20 billion in 2025 [7] - The global long-acting injectable antipsychotic market is projected to be in the $6 billion-$7 billion range for 2025, with strong growth expected [12] Company Strategy and Development Direction - The company plans to initiate a dedicated phase III program for Nereus in the first half of 2026, targeting the GLP-1 agonist market [7] - Vanda aims to strengthen its psychiatry franchise with the anticipated approval of Bysanti for bipolar I disorder and schizophrenia, with a PDUFA target action date of February 21, 2026 [8][17] - The company is committed to delivering innovative therapies and long-term value for patients and shareholders [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the commercial launch of Nereus and the potential for significant market opportunities in motion sickness [6] - The company expects total revenues of $230 million-$260 million from current marketed products in 2026, indicating continued growth [17][40] - Management highlighted the importance of strategic investments in commercial infrastructure to support long-term market leadership [26] Other Important Information - The company recorded a valuation allowance of $113.7 million against all deferred tax assets, which is a one-time, non-cash charge [22][24] - Cash, cash equivalents, and marketable securities as of December 31, 2025, were $263.8 million, a decrease of $110.8 million compared to the previous year [26] Q&A Session Summary Question: Can you characterize any FDA communication on outstanding issues related to Bysanti? - Management remains optimistic for an on-time approval and will provide more details on the launch strategy once commercial supplies are ready [48] Question: What is the expected commercial infrastructure for imsidolimab? - A small specialty sales force will be key for addressing the rare dermatological condition associated with imsidolimab [50] Question: Can you provide details on promotional activities for Fanapt and Bysanti? - Current direct-to-consumer campaigns focus on Fanapt and Ponvory, with plans for a dedicated campaign for Bysanti upon its launch [52] Question: When will Nereus be commercially available? - Commercial materials are expected to be ready by late Q2 or early Q3 2026 [54] Question: What is the expected pricing for Nereus? - Pricing is not yet communicated, but it is expected to be at a premium compared to existing treatments for motion sickness [71]

Financial Data and Key Metrics Changes - Total revenues for the full year 2025 were $216.1 million, a 9% increase compared to $198.8 million for 2024 [18] - Net product sales for Fanapt were $117.3 million, a 24% increase from $94.3 million in 2024 [18] - The company recorded a net loss of $220.5 million for 2025, compared to a net loss of $18.9 million in 2024 [21] - Operating expenses for 2025 were $367.3 million, up from $239.4 million in 2024 [24] Business Line Data and Key Metrics Changes - Fanapt's total prescriptions increased by 28% in 2025 compared to 2024 [19] - HETLIOZ net product sales were $71.4 million for 2025, a 7% decrease from $76.7 million in 2024 due to generic competition [20] - Ponvory net product sales were $27.4 million for 2025, a 2% decrease from $27.8 million in 2024 [21] Market Data and Key Metrics Changes - The total addressable market for the antipsychotic category is estimated at approximately $20 billion in 2025 [7] - The long-acting injectable antipsychotic market is projected to be in the $6 billion-$7 billion range for 2025 [12] Company Strategy and Development Direction - The company plans to initiate a dedicated phase III program for Nereus in the first half of 2026, targeting the GLP-1 agonist market [7] - Vanda aims to strengthen its psychiatric franchise with the anticipated approval of Bysanti for bipolar I disorder and schizophrenia [17] - The company is focused on expanding its commercial infrastructure and brand visibility through targeted sponsorships and marketing programs [26][36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the commercial launch of Nereus and the potential for significant market opportunities in motion sickness [6] - The company expects total revenues of $230 million-$260 million from current marketed products in 2026, indicating continued growth [40] - Management highlighted the importance of addressing unmet medical needs in major depressive disorder and social anxiety disorder through innovative therapies [10][12] Other Important Information - The company recorded a one-time, non-cash income tax charge of $113.7 million for the valuation allowance against deferred tax assets [22] - Cash, cash equivalents, and marketable securities as of December 31, 2025, were $263.8 million, a decrease of $110.8 million compared to the previous year [26] Q&A Session Summary Question: Can you provide updates on Bysanti's FDA review and commercial strategy? - Management indicated optimism for an on-time approval and mentioned that commercialization would begin in Q3 2026 if approved [48] Question: What is the expected commercial infrastructure for Imsidolimab? - A small specialty sales force will be dedicated to marketing Imsidolimab, focusing on dermatologists and advocacy organizations [50] Question: Can you elaborate on promotional activities for Fanapt and Bysanti? - Current direct-to-consumer campaigns focus on Fanapt and Ponvory, with plans for a dedicated campaign for Bysanti upon its launch [52] Question: When will Nereus be commercially available? - Nereus is expected to be commercially available by late Q2 or early Q3 2026 [54] Question: What is the pricing strategy for Nereus? - While a specific price has not been communicated, it is expected to be at a premium compared to existing treatments for motion sickness [71]

Financial Data and Key Metrics Changes - Total revenues for the full year 2025 were $216.1 million, a 9% increase compared to $198.8 million for 2024 [16] - Net loss for the full year 2025 was $220.5 million, compared to a net loss of $18.9 million for 2024, primarily due to a one-time, non-cash income tax charge [18][19] - Operating expenses for the full year 2025 were $367.3 million, an increase from $239.4 million in 2024 [21] Business Line Data and Key Metrics Changes - Fanapt net product sales increased by 24% to $117.3 million in 2025, driven by a 28% rise in total prescriptions and a 149% surge in new-to-brand prescriptions [5][17] - HETLIOZ net product sales decreased by 7% to $71.4 million in 2025 due to generic competition [17] - Ponvory net product sales were $27.4 million, a slight decrease of 2% compared to 2024 [18] Market Data and Key Metrics Changes - Fanapt was one of the fastest-growing atypical antipsychotics in the market throughout 2025, with total prescriptions increasing by 36% in Q4 2025 compared to Q4 2024 [31] - The global long-acting injectable antipsychotic market is projected to be valued between $6 billion and $7 billion in 2025, with strong growth expected [11] Company Strategy and Development Direction - The company plans to launch Nereus for motion sickness, which was approved in late 2025, targeting a substantial market opportunity [6] - Vanda is preparing for the commercial launch of Bysanti, with a focus on transitioning patients from Fanapt [41] - The company aims to strengthen its psychiatric franchise with ongoing clinical development programs and potential new product approvals [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the commercial potential of Nereus and the upcoming launch of Bysanti, anticipating continued revenue growth from existing products [15][34] - The company expects total revenues from marketed products in 2026 to be between $230 million and $260 million, indicating a growth of approximately 13% compared to 2025 [34] Other Important Information - Cash, cash equivalents, and marketable securities as of December 31, 2025, were $263.8 million, a decrease of $110.8 million compared to the previous year [23] - The company recorded a valuation allowance against all net deferred tax assets, resulting in a non-cash income tax expense of $113.7 million for 2025 [21] Q&A Session Summary Question: Can you characterize any FDA communication on Bysanti? - Management remains optimistic for an on-time approval and will provide more details on the launch strategy if approved [41][42] Question: What is the expected commercial infrastructure for Imsidolimab? - A small specialty sales force will be key for addressing the rare dermatological condition [44] Question: What promotional activities are planned for Fanapt and Bysanti? - A direct-to-consumer campaign for Fanapt and Ponvory is expected to continue, with a dedicated campaign for Bysanti planned if approved [45] Question: When will Nereus be commercially available? - Commercial materials are expected to be ready by late Q2 or early Q3 2026 [46] Question: What is the pricing strategy for Nereus? - Pricing is expected to be premium compared to existing treatments for motion sickness [65] Question: Will the phase 3 trial for tradipitant follow the same design as phase 2? - Yes, the design will be similar, using a high upfront dose of Wegovy [68]

Faga described the remaining royalty-focused entity as anchored by two assets: royalties on GSK’s Jemperli and potential economics from imsidolimab, which Anaptys has outlicensed to Vanda.The biopharma business is expected to house three clinical-stage programs, and “most, if not all” employees would move into the new company, which will have a new name and remain publicly traded. Faga said the new biopharma entity would be capitalized with at least enough cash to reach key readouts in the CD122 program “pl ...

AnaptysBio Conference Call Summary Company Overview - **Company**: AnaptysBio (NasdaqGS:ANAB) - **Event**: Guggenheim Emerging Outlook Biotech Summit 2026 - **Date**: February 11, 2026 Key Points Company Separation - AnaptysBio is in the process of separating its biopharma operations from its core royalty portfolio, targeting a Q2 2026 separation date [4] - The biopharma business will include three clinical stage programs: - Rosnilimab (completed Phase 2b study in RA, moving to Phase 3) [5] - CD122 program (two studies: one ongoing in celiac disease, one initiating in EOE) [5] - ANB101 (BDCA2 modulator, ongoing Phase 1 trial) [5] - The new biopharma entity will be publicly traded and capitalized adequately to support its clinical trials [5] Royalty Portfolio - The royalty business is anchored on two programs: - Jemperli (royalty from GSK, projected to generate $1.8 billion in revenue this year) [6] - Imsidolimab (outlicensed to Vanda, seeking accelerated approval) [6] - Jemperli's growth rate is expected to remain strong, with significant market share capture anticipated due to its survival data compared to competitors [8][10] - GSK's guidance suggests potential peak sales of over $2.7 billion, with a long runway for growth [14] Clinical Programs - **Rosnilimab**: - End-of-phase 2 meeting with the FDA scheduled to define the size of the Phase 3 program [138] - Focus on securing funding for the Phase 3 program while prioritizing the separation of the companies [146] - **CD122 Program**: - Differentiated mechanism targeting both IL-15 and IL-2 signaling, with applications in celiac disease and eosinophilic esophagitis (EOE) [57][68] - Ongoing studies in celiac disease aim to demonstrate therapeutic benefits for patients with gluten exposure [97][103] - EOE studies will focus on both eosinophil reduction and symptomatic impact, with data expected in 2027 [114] - **ANB101 (BDCA2 Modulator)**: - Competing with a first-generation BDCA2 in Phase 3 trials by Biogen, with AnaptysBio's drug showing a differentiated depletion profile [121][125] Market Potential - Celiac disease has over 2 million patients in the U.S., with approximately 250,000 non-compliant to a gluten-free diet, representing a significant market opportunity [97] - The EOE market is also substantial, with a need for effective treatments beyond existing options [114] Financial Considerations - AnaptysBio has $310 million in cash at the beginning of the year, sufficient to fund operations into 2028 if allocated to the biopharma business [51] - The company has been actively repurchasing stock, indicating confidence in its valuation and future prospects [46] Regulatory Environment - The company is navigating ongoing litigation related to Jemperli, but it does not impact the planned separation of the biopharma business [16][18] Conclusion - AnaptysBio is positioned for significant growth through its clinical programs and the separation of its business units, with a strong focus on capitalizing on its royalty portfolio and advancing its biopharma pipeline. The upcoming data releases and regulatory meetings will be critical in shaping the company's future trajectory.

Group 1 - AnaptysBio, Inc. is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [2] - The company's pipeline includes rosnilimab, ANB033, and ANB101, with various trials at different phases [2] - Anaptys has out-licensed therapeutic antibodies, including a PD-1 antagonist to GSK and an IL-36R antagonist to Vanda Pharmaceuticals [2] Group 2 - Anaptys plans to separate its biopharma operations from its royalty assets by year-end 2026, allowing investors to align their investment strategies with each company's objectives [3] - The company will participate in multiple investor conferences, including the Guggenheim Emerging Outlook and the TD Cowen Annual Health Care Conference [1] - Live webcasts of the investor meetings will be available on Anaptys' investor website, with replays accessible for at least 30 days [1]

2026 CORPORATE PRESENTATION January 2026 PHARMACEUTICALS INC. Various statements in this presentation, including, but not limited to, the guidance provided under "2025 Financial Guidance" and statements regarding Vanda's commercial products, plans, priorities and opportunities, as well as statements about Vanda's strategic focus and its products in development and the related clinical development and regulatory timelines and commercial and therapeutic potential for such products, are "forward-looking statem ...

Core Insights - AnaptysBio reported a significant insider sale by Director J. Anthony Ware, who sold 3,900 shares for $193,342.50, representing 28.82% of his direct holdings, during a period of strong share price gains [1][2][10] Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on developing antibody therapies for inflammatory and immune-mediated diseases [8] - The company has a market capitalization of $1.39 billion and reported revenue of $169.47 million for the trailing twelve months (TTM) [4] - The stock price increased by 264.63% over the past year, significantly outperforming the S&P 500's 17% gain [4][11] Transaction Details - The transaction involved a sale of 3,900 shares at a price of $49.58, with a post-transaction value of $481,885.20 based on the market close of $50.04 [2][4] - Post-transaction, Ware retains 9,630 shares and has options to purchase an additional 126,085 shares, along with 6,030 restricted stock units, indicating continued economic alignment with the company [10] Context of the Sale - This sale marks Ware's first open-market transaction at AnaptysBio, contrasting with previous administrative filings, suggesting a strategic decision rather than a shift in outlook [6][10] - The timing of the sale coincided with a high stock price following a substantial one-year return, indicating that the sale was likely a portfolio management decision [6][11] Company Performance - AnaptysBio reported $256.7 million in cash and investments at the end of the third quarter, with collaboration revenue increasing to $76.3 million from $30 million a year earlier [11] - The company's strong balance sheet and revenue visibility support the underlying investment thesis despite insider selling [11]

Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on developing novel antibody therapeutics for inflammatory and immunological conditions [5] - The company has a market capitalization of $1.24 billion and reported a revenue of $169.47 million for the trailing twelve months (TTM) [4] - The stock price as of Thursday was $44.71, reflecting a 1-year price change of 214.36% [4] Transaction Summary - Chief Medical Officer Paul F. Lizzul sold 3,650 shares for approximately $163,191.50, with a weighted average purchase price of $44.71 [2][11] - Post-transaction, Lizzul holds 42,088 shares, valued at approximately $1.84 million [2] - The sale was characterized as an administrative, sell-to-cover event to meet tax withholding obligations related to RSU vesting [9][11] Strategic Partnerships and Revenue Generation - AnaptysBio generates revenue through clinical-stage product development, milestone payments, and licensing agreements with major pharmaceutical partners [8] - The company collaborates with industry leaders to advance its pipeline and address significant unmet medical needs in immunology and inflammation [5][8] Financial Position and Future Outlook - As of the end of the third quarter, AnaptysBio had $256.7 million in cash, cash equivalents, and investments, with expectations to exit 2025 with approximately $300 million [10] - The board has expanded its stock repurchase authorization to $100 million, indicating confidence in the durability of royalty inflows and capital flexibility [10]