Assertio (NasdaqCM:ASRT) Q4 2025 Earnings call March 16, 2026 04:30 PM ET Company ParticipantsAjay Patel - CFODaniel Santos - SVPMark Reisenauer - CEOPaul Schwichtenberg - President and COORaghuram Selvaraju - Managing DirectorScott Henry - Managing DirectorConference Call ParticipantsNazibur Rahman - VP and Equity Research AnalystThomas Flaten - Senior Research AnalystOperatorLadies and gentlemen, thank you for standing by. My name is Abby, and I will be your conference operator today. At this time, I woul ...

Financial Data and Key Metrics Changes - In Q4 2025, net product revenues were $22.3 million, up from $16.4 million in Q4 2024, indicating a strong performance [21] - For the full year 2025, net product revenues reached $73.6 million, compared to $69.3 million in 2024, showing stability in revenue generation [21] - Total operating expenses for Q4 2025 were $41 million, while for the full year, they were $202.9 million, reflecting a disciplined approach to cost management [21][22] - The net loss for Q4 2025 was $6.4 million, significantly reduced from a loss of $30.7 million in Q4 2024 [22][23] Business Line Data and Key Metrics Changes - The focus on ZYNLONTA has led to a refined go-to-market model, maintaining its position in the third-line plus DLBCL setting despite increased competition from bispecific therapies [5][6] - The company anticipates significant growth opportunities in the second-line plus DLBCL setting with LOTIS-5, expecting to share top-line data in Q2 2026 [8][10] Market Data and Key Metrics Changes - The treatment landscape for DLBCL is evolving, with a current 60/40 split between complex therapies and broadly accessible therapies, impacting market dynamics [15] - The company estimates that achieving a 10% market share in the second-line setting could translate to an additional $200 million to $300 million in revenue [20] Company Strategy and Development Direction - The strategic plan focuses on optimizing lifecycle management for ZYNLONTA, including advancing LOTIS-5 and initiating LOTIS-7 [5][6] - The company aims to establish ZYNLONTA as a backbone therapy in DLBCL, targeting peak annual revenues of $600 million to $1 billion with regulatory approvals and compendia listings [7][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's path forward, highlighting a strengthened balance sheet and a cash runway expected to last into 2028 [10][24] - The anticipated data catalysts in 2026 are expected to drive significant long-term growth, particularly with the LOTIS-5 and LOTIS-7 trials [25][26] Other Important Information - The company has successfully reduced its operating cost structure by approximately 50%, enhancing its strategic flexibility [5][6] - The amendment to the royalty purchase agreement with HealthCare Royalty reflects the company's confidence in ZYNLONTA's long-term value [9][10] Q&A Session Summary Question: How are PFS events tracking for LOTIS-5? - Management is confident in the Q2 timing for the top-line readout and will share primary and secondary endpoints at that time [29][30] Question: Is the $200-$300 million opportunity for LOTIS-5 conservative? - Management believes the profile seen in the safety run-in supports a meaningful role in the second-line plus DLBCL market, with potential for higher peak sales depending on clinical outcomes [34][35] Question: What is the expected R&D spend moving forward? - R&D expenses are expected to decrease in 2026 and 2027, assuming the current number of trials remains stable [42][44] Question: How will capital allocation priorities be managed? - The company is focused on driving ZYNLONTA growth and has allocated capital for ongoing trials and pre-launch activities [48][50] Question: What is the current commercial run rate for ZYNLONTA? - The company has maintained its market share despite increased competition, with expectations for significant sales growth following LOTIS-5 approval [58][59]

Financial Data and Key Metrics Changes - Revenues for the year ended December 31, 2025, were $109.8 million, a 21% increase from $90.4 million in 2024, driven by the commercial launch of Zusduri and increased sales of Jelmyto [18] - The net loss for 2025 was $153.5 million, or $3.19 per share, compared to a net loss of $126.9 million, or $2.96 per share in 2024 [21] - Cash equivalents and marketable securities totaled $120.5 million as of December 31, 2025 [21] Business Line Data and Key Metrics Changes - Zusduri generated $15.8 million in revenue for 2025, reflecting early launch dynamics [4] - Jelmyto generated net product revenue of $94 million for the full year 2025, indicating continued underlying demand growth [5][16] Market Data and Key Metrics Changes - As of December 31, 2025, there were 838 activated sites of care with 102 unique prescribers and 32 repeat prescribers for Zusduri [14] - Over 95% of covered lives had open access to Zusduri by year-end 2025 [14] Company Strategy and Development Direction - The primary focus is on the commercial launch of Zusduri, which addresses a large and underserved market, with potential peak revenue exceeding $1 billion [5] - The company is advancing its pipeline, including UGN-103 and UGN-104, with plans for NDA submissions and potential FDA approvals in 2026 and 2027 [6][11] - A refinancing agreement with Pharmakon Advisors has strengthened the balance sheet and enhanced financial flexibility [7][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early adoption of Zusduri, with positive feedback from prescribers and patients regarding its ease of use and clinical effectiveness [9][10] - The company anticipates that the conversion timeline from patient enrollment forms to dosing will improve as sites gain familiarity with the product [15] Other Important Information - The company is not providing formal sales guidance for Zusduri in 2026 due to its early launch stage but expects Jelmyto net product revenues to be in the range of $97 million to $101 million [23] - Full-year 2026 operating expenses are expected to be between $240 million and $250 million, driven by sales force expansion and lifecycle management plans [24] Q&A Session Summary Question: Insights on patient enrollment forms and potential guidance for Zusduri - Management indicated that they could consider providing formal guidance for Zusduri at least two quarters post the permanent J-code [28] - There has been a noticeable increase in key indicators since the J-code became effective, including new and repeat prescribers [30][31] Question: Trends in repeat prescribers and feedback from non-repeat prescribers - There is steady growth in both new and repeat prescribers, with positive experiences leading to increased confidence in reimbursement [36] Question: Lifecycle management and market introduction of UGN-103 - UGN-103 is expected to be introduced after obtaining a permanent J-code, with a potential launch in early 2028 [38] Question: Current use of Zusduri among different patient types - Zusduri is being used primarily for patients who recur early, have frequent recurrences, or are unfit for surgery, with enthusiasm from physicians regarding its clinical data [45][46] Question: Community versus academic center adoption of Zusduri - The utilization mix has shifted towards community settings, with approximately 50% of usage now in community practices [53][54]

Summary of Catalyst Pharmaceuticals Conference Call Company Overview - **Company**: Catalyst Pharmaceuticals (NasdaqCM: CPRX) - **Key Products**: Agamree and Firdapse - **Focus**: Rare diseases and orphan drug development Key Points Business Development and Licensing - Catalyst Pharmaceuticals is focused on business development (BD) and licensing as core components of its strategy, particularly concerning Firdapse's intellectual property (IP) resolution before significant capital deployment [4][5][18] - The company has assessed over 100 opportunities since the beginning of the year, indicating a proactive approach to identifying potential acquisitions [6][7] Financial Position - Catalyst has approximately $689 million in cash and no funded debt, positioning it as a strong bidder in the market [9] - The company is cautious about entering bidding wars with larger players and aims to focus on opportunities that are immediately accretive or nearly so [5][9] Product Performance and Market Potential - Firdapse has the potential to exceed $500 million in revenue, with a focus on lifecycle management to optimize patient engagement and product usage [11][12] - Agamree is showing promising patient sourcing, with 45% from Emflaza, 45% from Prednisone, and 10% naive patients, indicating strong market acceptance [29][30] - The addressable market for steroids is estimated to be above $1 billion, with the potential for significant growth if the product proves effective in clinical trials [33][34] Clinical Trials and Research - The SUMMIT trial is critical for validating the efficacy of Agamree, with expectations of positive outcomes based on previous trials [35][36] - The company is conducting a phase one study to determine the immunosuppressive dose of Agamree, which could open new therapeutic avenues [15][17] Intellectual Property and Litigation - Catalyst is actively defending its IP for Firdapse, having settled with three out of four defendants in ongoing litigation [18][50] - The company believes its patent estate is robust, which is crucial for maintaining market exclusivity [50][69] Market Dynamics and Competitive Landscape - The company is facing generic competition for Fycompa, but brand stickiness is reportedly holding up better than expected [63][64] - The introduction of generics has not significantly dented Firdapse's business, indicating strong market positioning and patient loyalty [70] Future Outlook and Strategic Focus - Catalyst aims to expand its portfolio into other rare conditions requiring long-term steroid use, focusing on patient populations that can benefit most from its products [46][48] - The company is also exploring opportunities in the oncology space, particularly for cancer-associated LEMS patients, which could enhance its market reach [55][76] Capital Allocation - A $200 million share repurchase program has been authorized, signaling confidence in the company's financial health while maintaining flexibility for business development [66][67] - The company is committed to balancing capital allocation between share buybacks and potential acquisitions [67] Payer Coverage and Market Access - Payer coverage for Agamree is improving, with nearly 90% of prescriptions being approved, indicating growing acceptance among insurers [39][40] - The company is working to streamline the process for patients to access its therapies, which is critical for maintaining market share [39][40] Conclusion Catalyst Pharmaceuticals is strategically positioned in the rare disease market with a strong financial foundation and a focus on innovative product development. The company is actively managing its IP, exploring new market opportunities, and optimizing its existing product lines to drive growth and enhance shareholder value.

Core Insights - Mapi Pharma Ltd. is participating in the 8th Annual Evercore Annual Healthcare Conference to explore partnerships for its innovative long-acting depot injectable treatments [1][2] Company Overview - Mapi Pharma is a fully integrated, late-stage clinical development biopharmaceutical company focused on developing innovative long-acting depot injectable treatments [1][7] - The company has a strong intellectual property (IP) portfolio and utilizes extended-release depot technologies for lifecycle management products across multiple therapeutic areas [3][7] Product Pipeline - Mapi's lead product, GA Depot, is under a commercialization agreement for the treatment of Relapsing Forms of Multiple Sclerosis (RMS) and is currently under FDA review following successful Phase 3 results [3][7] - The development pipeline includes an injectable version of cariprazine for schizophrenia, bipolar I, and major depression disorders, with patient enrollment in a Phase I/II study recently initiated [4][7] - Other products in development include Depot formulations for Huntington's disease, tardive dyskinesia, and hormone receptor-positive early breast cancer [6][7] Research and Development Capabilities - Mapi has a dedicated R&D team and state-of-the-art GMP approved manufacturing facility, enabling efficient development of depot products [5][7] - The company is positioned to co-develop depot drugs with partners interested in long-acting injectable lifecycle management versions of their molecules [6][7]