Ligand Pharmaceuticals (LGND) FY Conference August 27, 2025 03:00 PM ET Speaker0Alrighty. Nice little Chicago hello. Next, we are pleased to welcome Ligand Pharmaceuticals, a company focused on developing and acquiring technologies that help drive innovation across the biotech and pharmaceutical industry. On behalf of Ligand, we are joined today by their vice president of strategic planning and investment analytics, Lauren Hay and Melanie Herman, executive director of investor relations in FPNA.Speaker1Grea ...

Summary of Travere Therapeutics (TVTX) FY Conference Call - August 13, 2025 Company Overview - **Company**: Travere Therapeutics - **Focus**: Development of therapies for rare diseases, particularly in rare nephrology and rare metabolics [3][4] Core Products - **Filspari**: - Approved for IgA nephropathy and in development for FSGS (Focal Segmental Glomerulosclerosis) - Unique as the only dual endothelin angiotensin receptor antagonist approved for these conditions [3][4] - **Pegtobatinib**: - Enzyme replacement therapy for classical homocystinuria (HCU) - Phase III study expected to begin enrollment next year [4][56] Commercial Performance - **Filspari Commercial Uptake**: - Accelerated approval received in February 2023, with a focus on becoming foundational care for IgA nephropathy [5][6] - Initial uptake was consistent with expectations, outperforming benchmark launches in the renal space [6] - Demand increased from approximately 500 patient start forms (PSFs) to around 700 PSFs following full approval in September [7][8] - 96% payer coverage achieved, with improvements in reimbursement timelines from 20-60 days to the lower end of that range [11][12] Regulatory Updates - **Supplemental NDA (sNDA)**: - Filed to modify Risk Evaluation and Mitigation Strategy (REMS) to remove embryo-fetal toxicity monitoring and adjust liver monitoring requirements [13][14] - Expectation for approval by PDUFA date of August 28 [17] Market Dynamics - **IgA Nephropathy Landscape**: - Recent approvals in the space (e.g., Tepalta, Venrafia) have not negatively impacted Filspari's market approach [23][24] - Over 70,000 addressable patients in the IgA nephropathy market, with KDIGO guidelines emphasizing ambitious treatment goals [25][26] - Filspari's unique position as the only non-immunosuppressive therapy approved for all patients at risk of progression [31] FSGS Market Potential - **FSGS Market Size**: - Potential to be larger than IgA nephropathy, with approximately half the patient population [47] - Nephrologists are more aware of the need for early treatment in FSGS, leading to a motivated patient and physician group [48] - Anticipated strong uptake due to existing experience with Filspari among nephrologists [49] Sales Strategy - **Sales Force Expansion**: - Incremental increase in sales force to maintain market share in IgA nephropathy and target pediatric nephrologists for FSGS [51][55] - Over 80% overlap in physicians treating both IgA nephropathy and FSGS patients [54] Future Outlook - **PDUFA Date for FSGS**: January 2026, with expectations for a strong narrative based on clinical data and alignment with recent Parasol workshop findings [35][42] - **Pegtobatinib**: Anticipated enrollment in Phase III study for HCU, targeting a patient population of 7,000-10,000 in the US [56] Conclusion - Travere Therapeutics is positioned for significant growth with Filspari and pegtobatinib, leveraging strong clinical data and market dynamics to enhance patient care in rare diseases [57][58]

Safe Harbor Statement and Disclaimers • This presentation contains forward-looking statements, as defined in Section 21E of the Securities Exchange Act of 1934, by Ligand and its partners thatinvolve risks and uncertainties and reflect Ligand's and its partners' judgmentasofthedateofthispresentation.All statements,otherthan statementsof historicalfact, couldbedeemedtobeforward-lookingstatements, includingstatements thatexpress Ligand'sorits partners'opinions, expectations,objectives, assumptions,plans orpro ...

Financial Data and Key Metrics Changes - In Q2 2025, net product sales reached approximately $94.8 million, representing an 82% year-over-year growth [22][24] - FILSPARI net product sales in the U.S. were approximately $71.9 million, showing significant year-over-year growth [22][16] - The net loss for Q2 2025 was $12.8 million or $0.14 per basic share, compared to a net loss of $70.4 million or $0.91 per basic share for the same period in 2024 [25] Business Line Data and Key Metrics Changes - FILSPARI's performance in the IgA nephropathy market was highlighted, with strong demand from both new and repeat prescribers [5][16] - The commercial team reported 745 new patient start forms in Q2, a 43% increase compared to the same period last year [17] - THIOLA and THIOLA EC contributed $23 million in net product sales for the second quarter [22] Market Data and Key Metrics Changes - The company is preparing for a potential launch of FILSPARI for FSGS, with a PDUFA date set for January 13, 2026 [14] - The addressable patient population for FILSPARI in the U.S. is estimated at 70,000, with about 70% having elevated proteinuria levels below 1.5 grams per gram [81] Company Strategy and Development Direction - The company aims to establish FILSPARI as the foundational therapy for IgA nephropathy and is advancing its pipeline for rare diseases [5][10] - The strategy includes generating robust clinical evidence, broad access aligned with full approval indications, and real-world clinical experience [6][7] - The company is focused on expanding its commercial organization in preparation for the potential FSGS launch [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of FILSPARI, driven by robust underlying demand and the anticipated removal of certain REMS [26][20] - The management team highlighted the importance of early intervention in treatment and the growing recognition of FILSPARI's nephroprotective profile [18][19] - The company remains optimistic about its strategy and the feedback from the medical community [20] Other Important Information - The company recognized $19.6 million in licensing collaboration revenue, including a one-time milestone payment of $17.5 million from CSL Vifor [23] - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling approximately $319.5 million [25] Q&A Session Summary Question: What do you anticipate the major topics could be for the FSGS AdCom? - Management indicated the need for educational components about the disease and the importance of proteinuria as a validated endpoint [31][34] Question: Can you comment on the cadence and level of engagement with the FDA regarding the REMS update for FILSPARI? - Management noted that interactions with the FDA have been progressing as expected, similar to previous experiences [38][40] Question: When will you gain insight into the timing of the advisory committee panel meeting? - Management stated that the advisory committee meeting is expected to take place sometime in Q4, given the PDUFA date of January 13 [45][47] Question: What would it take to remove the REMS entirely? - The strategy involves a two-step process, first seeking to lessen testing frequency and then pursuing full removal [51][52] Question: How are the new data from recent studies being received by the medical community? - The data have been received positively, with excitement about the nephroprotective effects of FILSPARI [54][56] Question: Can you comment on the dynamics and breakdown of growth contributions from stocking, new patients, and persistence rates? - Management confirmed that the revenue growth was performance-driven, with high persistence rates and strong demand [59][62] Question: What are the headwinds or bottlenecks in terms of uptake? - Management identified the urgency to treat patients as a key issue, but noted that the introduction of new treatment options is expected to help [105][106]

Financial Performance and Guidance - Ligand's total revenue guidance for 2024 is $160-$165 million[21], with royalty revenue expected to be $105-108 million[22], representing a 27% increase from 2023[30] - The company anticipates adjusted EPS of $550-$570 in 2024[22], a 38% growth[30] - For 2025, Ligand forecasts total revenue of $180-$200 million[34], with royalty revenue growing by 30% over 2024[35] - Ligand projects royalty receipts to grow at a CAGR of 22% from 2024 to 2029[24, 40] Investment and Portfolio Activity - Ligand deployed $192 million across 8 different investments in 2024[21] - The company's Q4 pipeline includes over 30 actionable opportunities, representing over $1 billion of potential investments[61] - Ligand acquired Apeiron Biologics in July 2024 for approximately $100 million, gaining rights to Qarziba royalties[70] Key Products and Platforms - Ligand's Captisol platform is used in 16 approved products[99, 104] - Verona's Ohtuvayre, in which Ligand has royalty rights, achieved over $11 million in sales in the first 4 months following approval[75] - Travere's Filspari generated $356 million in Q3 2024, with 31% growth from Q2 2024[80] - Merck's Capvaxive, another royalty asset for Ligand, protects against strains that cause 84% of invasive pneumococcal disease[88]

Financial Data and Key Metrics Changes - The company reported total revenue of over $45 million for Q1 2025, representing a 46% increase from $31 million in the same period last year [33][34] - Adjusted earnings per share (EPS) for Q1 2025 was $1.33, up from $1.20 in Q1 2024 [42] - Royalty revenue increased by 44% year-over-year, totaling $27.5 million in Q1 2025 [34][35] Business Line Data and Key Metrics Changes - Varonis' O2VARE reported net sales of $71.3 million in Q1 2025, nearly double the previous quarter's results [37] - Trevyr's Filspari achieved first-quarter U.S. sales of $56 million, representing over 180% year-over-year growth [38] - Merck's Capaxib reported Q1 sales of $107 million, more than double the prior quarter [39] Market Data and Key Metrics Changes - The company has over $200 million in cash and investments, with no debt and access to a $125 million revolving credit facility [8] - The current biopharmaceutical financing environment is challenging, leading to increased demand for royalty financing [10][11] Company Strategy and Development Direction - The company aims to deliver profitable and compounding growth through a diversified portfolio of royalty assets [14][16] - A focus on acquiring late-stage development assets and commercial assets with superior risk-reward profiles is central to the company's strategy [15][17] - The company anticipates long-term royalty revenue growth to meet or exceed a 22% compound annual growth rate [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future prospects, citing a strong start to 2025 and the potential for significant growth drivers [44] - The company is navigating short-term disruptions due to policy changes but remains focused on delivering clinical value [50][56] - Management noted that the current environment presents opportunities for mergers and acquisitions in the biotech sector [49] Other Important Information - The company executed a strategic transaction to merge its subsidiary, Pylthos Therapeutics, with Channel Therapeutics, raising $50 million in equity capital [22] - ZELSUVME, an FDA-approved therapy for molluscum contagiosum, is positioned as a first-line treatment option [29][31] Q&A Session Summary Question: Current environment for the space and special situations - Management noted an increase in special situations due to difficult financing markets for biotech companies, presenting good opportunities for the company [48][50] Question: Impact of most favored nation's status for drug pricing - Management indicated that while there may be short-term disruptions, the long-term outlook remains positive as most partners focus on the U.S. market [55][58] Question: Investment capacity and opportunities - Management expects to invest above the normal pace this year due to the number of good opportunities, while maintaining diversification limits [76][78] Question: Launch timing for ZELSUVME - The launch is expected to be independent of the merger closing, with preparations already underway [83] Question: Revenue trends for the year - Management anticipates a balanced revenue cadence throughout the year, reiterating guidance for Captisol and royalty revenue [88]

Core Insights - Ligand Pharmaceuticals reported a strong first quarter performance with total revenues of $45.3 million, a 46% increase from $31.0 million in the same period of 2024, driven by a 44% growth in royalty revenue [4][5] - The company reaffirmed its 2025 financial guidance, expecting total revenues between $180 million and $200 million, with adjusted earnings per diluted share projected to be between $6.00 and $6.25 [8][7] - Ligand's CEO highlighted the strength of the commercial royalty portfolio and the strategic transaction with Channel Therapeutics to accelerate the launch of ZELSUVMI, which is expected to create significant value for shareholders [3][9] Financial Performance - Total revenues for Q1 2025 were $45.3 million, with royalties contributing $27.5 million and Captisol sales at $13.5 million [4][5] - Research and development expenses surged to $50.1 million, primarily due to a one-time charge of $44.3 million related to a royalty financing agreement with Castle Creek Biosciences [4][5] - The GAAP net loss for Q1 2025 was $42.5 million, or $2.21 per share, compared to a net income of $86.1 million, or $4.75 per diluted share, in Q1 2024 [5][29] Strategic Transactions - Ligand announced a merger agreement with Channel Therapeutics, which will be supported by $50 million in capital from strategic investors [9][10] - The combined entity will focus on the commercialization of ZELSUVMI, the first FDA-approved prescription therapy for molluscum contagiosum infections [11][9] - Ligand's investment of $18 million in the combined company reflects its commitment to the growth of Pelthos Therapeutics [10][9] Portfolio Updates - Verona reported Ohtuvayre net sales of $71.3 million for Q1 2025, a 95% increase compared to the previous quarter [13] - Travere Therapeutics received European Commission approval for Filspari, enhancing its market position [14] - UroGen and Merck also reported significant advancements in their respective product pipelines, indicating a robust biopharmaceutical landscape [15][17] Cash Position - As of March 31, 2025, Ligand had cash, cash equivalents, and short-term investments totaling $208.9 million, including $24.2 million in Viking Therapeutics common stock [6][32]