Vanda Pharmaceuticals Announces Participation in the 2026 Citizens Life Sciences Conference [Accessibility Statement] Skip NavigationWASHINGTON, Feb. 26, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the 2026 Citizens Life Sciences Conference in Miami on Wednesday, March 11, 2026. A corporate presentation is scheduled for 2:15 p.m. Eastern Time.The corporate presentation given at the Citizens Life Sciences Conference may be access ...

AnaptysBio Conference Call Summary Company Overview - **Company**: AnaptysBio (NasdaqGS:ANAB) - **Date**: February 12, 2026 Key Points Separation of Royalty Pharma and Biopharma - The separation of the royalty company and the biopharma business is a top priority, targeted for completion in Q2 2026, though it may extend beyond April 1 [2][4] - The royalty company will focus on recognizing the value of commercial entities with low operational expenses, driven by the growth of Jemperli and Imsidolimab [4][5] Financial Position - AnaptysBio started the year with $310 million in cash, approximately $11 per share [7] - The company plans to allocate sufficient cash to the biopharma business to support operations through 2027, potentially extending cash reserves into 2028 [7][8] Jemperli Performance - Jemperli reported Q4 sales of $343 million, reflecting a 13% quarter-over-quarter growth [12] - It is positioned as a best-in-class PD-1 antagonist, with significant growth potential driven by multiple indications, including rectal cancer and MSI-H colon cancer [13][15] - Analysts have not fully recognized Jemperli's growth potential, with some assigning negative growth rates despite its rapid sales increase [14] ANB033 and Celiac Disease - ANB033, a CD122 antagonist, is being developed for celiac disease, targeting a market with over 2 million patients in the U.S. [21][22] - The study design includes a gluten challenge with a focus on histological outcomes and patient-reported outcomes [24][25] - Data readout is expected in Q4 2026, with enrollment having started in Q4 2025 [27][28] Eosinophilic Esophagitis (EoE) - The company is also advancing a program for EoE, with a focus on reducing eosinophils and improving patient-reported outcomes [52] - The market for EoE is significant, with dupilumab generating approximately $2 billion annually [48] Rosnilimab Development - Rosnilimab has shown promising results in rheumatoid arthritis, with plans to advance it through partnerships rather than using balance sheet cash [55][56] - An update on the phase 3 advancement is expected in the first half of 2026 [54] BDCA2 Modulator (ANB101) - ANB101 is in phase 1 development, with potential applications in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) [60] - The company is monitoring Biogen's trials for insights on advancing ANB101 [61] Legal Considerations - Ongoing litigation with GSK regarding contractual issues could impact the royalty business, with potential for the drug to revert back to AnaptysBio [65][66] Conclusion - AnaptysBio is positioned for significant developments in 2026, with multiple catalysts including the separation of its businesses, Jemperli's growth, and advancements in its clinical programs [68]

Core Insights - Vanda Pharmaceuticals reported a strong financial performance for the full year 2025, with total revenues increasing by 9% to $216.1 million compared to 2024, driven primarily by a 24% increase in net product sales of Fanapt® [1][2] - The company is awaiting FDA approval for Bysanti™ (milsaperidone) for bipolar I disorder and schizophrenia, with a target action date of February 21, 2026, which could expand its psychiatry franchise [1][2] - The FDA approved NEREUS™ (tradipitant) for the prevention of motion-induced vomiting, marking a significant milestone as the first new oral therapy for this condition in over 40 years [1][2] Financial Highlights - For Q4 2025, Vanda reported a net loss of $141.2 million, compared to a net loss of $4.9 million in Q4 2024, with a diluted net loss per share of $2.39 [2][4] - The provision for income taxes in Q4 2025 was $103.2 million, influenced by a non-cash charge of $113.7 million against deferred tax assets [1][2] - Full year 2025 net loss was $220.5 million, compared to $18.9 million in 2024, with a diluted net loss per share of $3.74 [2][4] Operational Highlights - Fanapt® saw a 24% increase in net product sales for the full year 2025, totaling $117.3 million, supported by a 28% rise in total prescriptions [1][2] - The company launched a direct-to-consumer campaign in 2025, enhancing brand awareness for Fanapt® and PONVORY® [1][2] - Vanda is preparing for the commercial launch of NEREUS™ and plans to initiate a Phase III program for its use in preventing vomiting from GLP-1 analogs in the first half of 2026 [1][2] Regulatory & Clinical Development - Vanda received a decision letter from the FDA regarding the sNDA for HETLIOZ® for jet lag disorder, indicating it cannot be approved in its current form [2] - Ongoing clinical studies include a Phase III study of the long-acting injectable formulation of iloperidone for schizophrenia and a Phase III study of VQW-765 for social anxiety disorder [2] - The company submitted a BLA for imsidolimab for generalized pustular psoriasis in Q4 2025 [2] 2026 Financial Guidance - Vanda expects total revenues for 2026 to be between $230 million and $260 million, with Fanapt® net product sales projected to be between $150 million and $170 million [2]

Vanda Pharmaceuticals FY Conference Summary Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on innovative therapies with a strong commercial portfolio anchored by four FDA-approved brands: Fanapt, Hetlioz, Ponvory, and Nereus [2][3] Core Products and Pipeline - **Fanapt**: An atypical antipsychotic approved for bipolar I disorder and schizophrenia. A long-acting injectable formulation is in phase three for schizophrenia, and a program for hypertension has been initiated [4][5] - **Hetlioz**: Approved for non-24-hour sleep-wake disorder and other sleep disturbances. It is at the regulatory stage for insomnia and jet lag disorder [6][7] - **Ponvory**: Approved for relapsing forms of multiple sclerosis, with ongoing phase three programs for psoriasis and ulcerative colitis [6][7] - **Nereus**: Recently approved for motion sickness, with potential applications in GLP-1 induced nausea and vomiting, and gastroparesis [6][7][10] Financial Performance - For Q3 2025, Vanda reported revenue of $56.3 million, with contributions from Fanapt ($31 million), Hetlioz ($18 million), and Ponvory ($7 million). The company expects total revenue for 2025 to be between $210 million and $230 million [21][22] Strategic Focus - The company aims to grow and diversify revenue by expanding existing products and introducing new ones, targeting six commercial products by the end of 2026 [3][4] - Upcoming regulatory catalysts include Bysanti's PDUFA date on February 21, 2026, and the initiation of phase three programs for GLP-1 induced vomiting [7][10] Market Opportunities - **Nereus**: The motion sickness market has approximately 30% of adults in the U.S. experiencing symptoms, translating to a potential patient population of around 12 million. The GLP-1 market, valued at over $50 billion, presents a significant opportunity for Nereus as an adjunct treatment [11][12][35] - **Bysanti**: Expected to extend the psychiatry portfolio, especially with a potential indication for major depressive disorder (MDD), which could open treatment options for an additional 20 million patients [15][31] Commercialization Strategy - Vanda has a robust sales force of around 300 reps, primarily targeting psychiatrists, but plans to expand efforts to include primary care physicians for Bysanti [26][28] - The company anticipates a transition strategy from Fanapt to Bysanti, leveraging existing resources to maintain revenue streams post-Fanapt's expected loss of exclusivity around 2027 [28][29] R&D Milestones - Nereus's approval for motion sickness was a significant milestone, with a commercial launch expected in the second half of 2026. The company is also pursuing additional indications for its products [7][10] - Imsidolimab, targeting generalized pustular psoriasis, is under priority review with a potential launch in summer 2026 [17][37] Conclusion - Vanda Pharmaceuticals is positioned for significant growth with a strong pipeline and strategic focus on expanding its product offerings. The upcoming regulatory milestones and market opportunities in motion sickness and the GLP-1 space are key drivers for future revenue growth [39]

Summary of AnaptysBio Conference Call Company Overview - **Company**: AnaptysBio - **Event**: 44th Annual JPMorgan Healthcare Conference - **CEO**: Dan Faga Key Points Company Separation - AnaptysBio plans to separate into two distinct businesses: BiopharmaCo and Royalty Management Co by Q2 2025 [1][2][34] - The separation aims to align different business strategies and investment philosophies, enhancing shareholder value [44][46] BiopharmaCo Developments - **Clinical Assets**: BiopharmaCo will focus on three clinical assets, primarily driven by AMB033, which is currently in phase 1b trials for Celiac disease and Eosinophilic Esophagitis (EoE) [2][12] - **AMB033**: A CD122 antagonist targeting IL-15 and IL-2 signaling, showing potential in treating Celiac disease and EoE [12][26] - **Market Opportunity**: Celiac disease has over 1 million diagnosed patients in the U.S., with a $5 billion market targeting those non-responsive to a gluten-free diet [16][17] Royalty Management Co Developments - The Royalty Management Co will manage royalties from Jemperli and Imsidolimab, with significant revenue potential from these assets [3][4] - **Jemperli**: Generated over $300 million in revenue in Q3 2025, with a tiered royalty structure starting at 8% and potentially reaching 25% at peak sales [4][5] - **Imsidolimab**: Expected approval in the U.S. later this year, with a 10% flat royalty from sales [6][7] Clinical Trials and Data - **Celiac Disease Trials**: The phase 1b trial will enroll 60 patients, focusing on preventing villus atrophy and healing damaged villi [22][50] - **EoE Trials**: A trial for EoE is set to initiate later this quarter, targeting a growing market currently dominated by Dupixent [25][54] - **Rosnilimab**: A phase 2b trial in rheumatoid arthritis showed positive results, with plans for a phase 3 program pending strategic partnerships or financing [28][29] Financial Position - AnaptysBio has $310 million in cash, sufficient to support ongoing trials and operations for the next couple of years [3][34] - The company anticipates paying down $250 million of its $600 million non-recourse debt by the end of 2025 [5][41] Market Competition and Strategy - Jemperli competes with Keytruda, with GSK focusing on differentiated data in women's cancers [11] - AnaptysBio's strategy includes targeting both IL-15 and IL-2 pathways, which may provide advantages over existing therapies [12][54] Litigation with GSK - Ongoing litigation with GSK regarding Jemperli is not expected to impede the separation of the biopharma business [39][40] - AnaptysBio claims GSK has breached contract terms, with a trial date set for July 2025 [41][43] Future Outlook - AnaptysBio is optimistic about the potential of its clinical assets and the upcoming separation, which is expected to create value for shareholders [46][49] - The company is exploring various financing options to support the advancement of its clinical programs [48][49] Additional Insights - The separation is seen as a strategic move to unlock value by allowing each entity to pursue tailored growth strategies [44][46] - The focus on both Celiac disease and EoE highlights AnaptysBio's commitment to addressing unmet medical needs in immunology [12][54]

Summary of AnaptysBio FY Conference Call (December 03, 2025) Company Overview - **Company**: AnaptysBio (NasdaqGS:ANAB) - **Industry**: Biopharmaceuticals Key Points Business Segments and Developments - **Biopharma Operations**: - **ANB033**: A CD122 antagonist, initiated a trial for celiac disease in 2025, with data expected in Q4 2026. A second trial for eosinophilic esophagitis (EOE) is planned for 2026 [4][19]. - **Rosnilimab**: Advanced program for rheumatoid arthritis (RA) with positive phase 2b data from a study involving 424 patients. Plans to move into phase 3 development in 2026 with external funding [4][12]. - **Royalty Management**: - **Jemperli**: Expected to generate $1.4 billion in sales at GSK, with significant royalty rights. The company plans to separate the royalty management business from biopharma assets in 2026 [5][31]. Clinical Trials and Efficacy - **Rosnilimab**: - Phase 2 trial in ulcerative colitis (UC) showed good safety but insufficient efficacy to continue. The focus will be on RA with a phase 3 design that includes placebo-controlled trials [6][8]. - 69% of patients achieved low disease activity (CDAI) by week 14, with a placebo-adjusted delta over 20% [11]. - Safety profile was unremarkable, with no malignancies or serious infections reported [15]. - **ANB033**: - Targeting celiac disease with a focus on mucosal healing, measuring villus height to crypt depth ratio. The phase 1B trial will assess both gluten challenge and patients with severe mucosal injury [20][22]. - The market for celiac disease treatment is estimated to be multi-billion dollars, with over 250,000 patients in the U.S. not well controlled on a gluten-free diet [26]. Financial and Strategic Considerations - The company anticipates ending 2025 with $300 million in cash, including $75 million milestone from GSK upon Jemperli exceeding $1 billion in sales [36]. - Plans to separate the biopharma and royalty management businesses in 2026, ensuring each can operate independently and maintain value [29][35]. - The royalty management business is projected to become cash flow positive by Q2 2027 [31][37]. Legal and Regulatory Issues - Ongoing litigation with GSK regarding Jemperli, with AnaptysBio contending that GSK is in breach of obligations related to the asset's development [33][34]. - The separation plans are independent of the litigation, ensuring that the biopharma operations can execute their strategy regardless of the trial outcome [35]. Market Outlook - The biopharma segment is expected to capture significant value post-separation, with potential for growth in both ANB033 and Rosnilimab [40]. - The company believes there is substantial upside in the biopharma business that is currently undervalued by the market [40]. Additional Insights - The company is exploring strategic partnerships for RA development while protecting its royalty stream [9][16]. - There is a focus on broadening the ANB033 program with potential for multiple indications, including EOE [39]. This summary encapsulates the critical developments and strategic outlook for AnaptysBio as discussed in the conference call, highlighting both opportunities and challenges within the biopharmaceutical landscape.

Strategic Separation to Maximize Shareholder Value Sept. 29, 2025 Safe harbor statement This presentation and any accompanying oral presentation contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from the Company's clinical trials, including initial data for rosnilimab's Phase 2 clinical trial in ulcerative colitis; expectations regarding the structure ...

Core Insights - Vanda Pharmaceuticals reported a significant increase in Fanapt revenue, driven by expanded sales efforts and a direct-to-consumer brand awareness campaign, with expectations for continued growth in upcoming quarters [2][6] - The company anticipates important regulatory and clinical milestones that could enhance its commercial portfolio and advance its clinical pipeline [2] Financial Highlights - In Q2 2025, net product sales from Fanapt® reached $29.3 million, a 27% increase from $23.2 million in Q2 2024 [6][7] - Total net product sales from Fanapt®, HETLIOZ®, and PONVORY® were $52.6 million in Q2 2025, a 4% increase compared to $50.5 million in Q2 2024 [7] - The net loss for Q2 2025 was $27.2 million, compared to a net loss of $4.5 million in Q2 2024 [9] - Cash and cash equivalents stood at $325.6 million as of June 30, 2025, reflecting a decrease of $15.4 million from March 31, 2025 [7] Operational Highlights - Bysanti™ NDA for bipolar I disorder and schizophrenia is under FDA review with a PDUFA target action date of February 21, 2026 [6][8] - Tradipitant NDA for motion sickness is also under review, with a PDUFA target action date of December 30, 2025 [6][14] - Fanapt® experienced a 24% increase in total prescriptions (TRx) in Q2 2025 compared to Q2 2024 [7] Financial Guidance - Vanda expects total revenues for the full year 2025 to be between $210 million and $250 million, with year-end cash projected to be between $280 million and $320 million [11]