Summary of Gossamer Bio FY Conference Call Company Overview - Gossamer Bio was founded in 2018 by Chairman and CEO Faheem Haznain, following a successful exit from Receptos, which was acquired by Celgene, now part of Bristol-Myers Squibb [4][6] - The company focuses on developing therapies for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD) [4][30] Key Developments and Data Readouts - Gossamer is nearing a key data readout for the PROCERRA study, a multinational Phase III registrational study involving 191 sites across 31 countries, with top-line results expected in February 2026 [6][10] - The company anticipates a 20 to 25 meter increase in six-minute walk distance as a primary endpoint for the PROCERRA study [6][16] - The PROCERRA study aims to enroll a patient population that is more representative of those who performed well in the previous Phase II Tory study, which was affected by the COVID-19 pandemic [8][10] Clinical Insights - The PROCERRA study has a patient demographic with a higher proportion of functional class III patients (approximately 70%) compared to the Tory study [9][10] - The study's design includes a focus on regions with historical efficacy, such as Latin America, which has shown better performance in similar studies [10][11] - The company has amended its protocol to allow patients on background therapy with cetatercept to enroll, but only a small number were able to do so due to adverse events associated with cetatercept [12][13] Commercial Strategy - Assuming positive trial results, Gossamer plans to position cerulutinib as a third-line treatment following standard care for PAH [19][20] - The company expects minimal payer resistance due to the rarity of the disease and the anticipated drop in treatment costs as existing therapies become generic by the time of cerulutinib's launch in 2027 [22][23] - Gossamer is building its commercial organization, with plans for a sales force of approximately 60 representatives to target major treatment centers [26][27] Market Opportunity - The economic opportunity for cerulutinib in PAH is estimated at $2.25 billion, with the potential for even greater revenue in the PHILD market due to less competition and a higher patient population [32][33] - The company has initiated a Phase III trial for PHILD, targeting a very sick patient population with high unmet medical needs [30][34] Pipeline Expansion - Gossamer has entered into a transaction to acquire an inhaled version of Vardenafil for PRN use, which could generate $500 to $750 million in the U.S. alone [39][41] - The acquisition is seen as a strategic move to enhance Gossamer's portfolio and establish long-term partnerships within the PAH community [42] Financial Position - Gossamer has sufficient cash to fund operations until May 2027, including the PROCERRA study and the PHILD trial [44]

Financial Data and Key Metrics Changes - The net asset value (NAV) increased by $252 million from the first quarter, primarily driven by positive performance in CVI, offset by decreases in auto service [5] - The investment funds ended down approximately 0.5% for the quarter, primarily driven by gains in the consumer cyclical sector, offset by broad market and refining hedges [6] - The holding company ended the quarter with $1.1 billion in cash and cash equivalents, and an additional $700 million of cash at the funds [10] Business Line Data and Key Metrics Changes - The Energy segment's consolidated EBITDA was negative $24 million for Q2 2025, compared to $103 million in Q2 2024, negatively impacted by unfavorable RINs valuation and reduced throughput volumes [14] - The auto service division saw revenues decrease by $8 million compared to the prior year quarter, but same-store revenues were relatively flat, improving from a 5% decline in the previous quarter [15] - The pharma segment initiated a pivotal trial for a new drug aimed at treating pulmonary arterial hypertension, with expectations for updates in 12 to 18 months [9][10] Market Data and Key Metrics Changes - CVI's share price increased by 38%, contributing to a $561 million increase in NAV from the first quarter [5] - The digital business at Caesars grew revenue by 24% and EBITDA by 100% in the second quarter, indicating strong market performance [12] Company Strategy and Development Direction - The company is focusing on maintaining liquidity to capitalize on opportunities within and outside existing operating segments, with a total liquidity of $3.5 billion at the holding company and $1.1 billion at subsidiaries [20] - The company plans to redeploy capital from the sale of a country club to replicate successful strategies in newly acquired properties [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the resolution of outstanding litigation related to small refinery exemptions, which could remove a $548 million liability [6] - The company sees considerable value creation potential in its portfolio, particularly in electric utilities and gas utilities, driven by AI-related demand [11] Other Important Information - The Board maintained the quarterly distribution at $0.50 per depositary unit [10] - The company closed 22 underperforming auto service locations, bringing the total to 44 for 2025, while planning to add 16 new locations by year-end [16] Q&A Session Summary Question: Regarding the decrease in cash balance at the holding company level - The decrease was primarily due to interest payments and LP distributions, with some impact from the CVR repurchase of about $32 million [22]

Financial Data and Key Metrics Changes - The company reported total revenues of $15.8 billion, a decrease of 2% both nominally and excluding foreign exchange impact [17] - Earnings per share were $2.13, with gross margin at 82.2%, an increase of 1.3 percentage points driven by favorable product mix [24][23] - The company expects full year revenue for 2025 to be between $64.3 billion and $65.3 billion, representing growth of 1% to 2% [26] Business Line Data and Key Metrics Changes - Oncology sales, particularly from Keytruda, increased by 9% to $8 billion, driven by robust demand for metastatic indications [18] - Sales of Gardasil decreased by 55% to $1.1 billion, primarily due to a decline in China [19] - The Animal Health business saw an 11% increase in sales, reflecting higher demand across all species [22] Market Data and Key Metrics Changes - Global growth excluding Gardasil in China was 7%, primarily driven by strength in oncology and animal health [17] - In the U.S., Vaxnuvance sales increased by 20%, benefiting from CDC stockpile activity [20] - The company anticipates a more significant headwind to growth in Japan for Gardasil in the second half of the year [28] Company Strategy and Development Direction - The company is focusing on a multi-year optimization initiative to redirect $3 billion of cost savings from lower growth areas to higher potential areas [25] - The acquisition of Verona Pharma is expected to enhance the cardiopulmonary program and reflects the company's commitment to transformative science [12] - The company aims to leverage its scientific expertise to deliver the next wave of innovations that can save and improve lives [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in returning to growth in 2025 and highlighted the strong clinical momentum and new product launches [9] - The company is entering a period of rapid transformation, with a diversified pipeline and over 20 new growth drivers [14] - Management acknowledged challenges in the Chinese market for Gardasil but remains focused on new product launches to drive growth [28] Other Important Information - The FDA approved Inflonsia for RSV prevention in infants, marking a significant milestone for the company [38] - The company is conducting over 80 phase three studies across various therapeutic areas, indicating strong clinical development activity [10] Q&A Session Summary Question: Context for outcomes in the Cadence trial - Management indicated that the most important signal for success is the PVR, with the six-minute walk also being important [52] Question: Market size for Winrevir and ex-U.S. strategy - Management noted that the patient population for Winrevir is underdiagnosed, and they expect growth in the ex-U.S. market as reimbursements come in [64] Question: $3 billion restructuring announcement - Management clarified that the $3 billion is a reallocation of resources from slower growth areas to fund faster-growing segments, with an expectation of overall growth in spending [70][72] Question: Gardasil demand dynamics and ACIP recommendations - Management expressed confidence in Gardasil's safety and efficacy but noted the high evidentiary standard set by the FDA for any changes in dosing recommendations [77] Question: Diligence in assets between Chinese and Western companies - Management emphasized a high standard for diligence regardless of the origin of the assets, highlighting the strategic advantage of the Verona acquisition [86] Question: Progress on Winrevir and patient adoption - Management reported steady growth in patient adds for Winrevir and increasing adoption among less severe patients [96]

Financial Data and Key Metrics Changes - The company reported total revenues of $15.8 billion, a decrease of 2% both nominally and excluding foreign exchange impact [16] - Earnings per share were $2.13, reflecting strong fundamentals despite revenue decline [23] Business Line Data and Key Metrics Changes - Oncology sales, particularly from Keytruda, increased by 9% to $8 billion, driven by robust demand in both US and international markets [17] - Sales of Gardasil decreased by 55% to $1.1 billion, primarily due to a decline in China [18] - Winrevir achieved global sales of $336 million, with cumulative sales exceeding $1 billion in just over a year since launch [20] - The Animal Health business saw an 11% increase in sales, reflecting higher demand across all species [21] Market Data and Key Metrics Changes - Global growth, excluding Gardasil sales in China, was 7%, driven by strength in oncology and animal health [16] - The company noted that Gardasil channel inventories in China remain elevated, with soft demand impacting sales [28] Company Strategy and Development Direction - The company announced a multi-year optimization initiative to redirect $3 billion in cost savings from lower growth areas to higher potential areas [25] - The acquisition of Verona Pharma is expected to enhance the cardiopulmonary program and reflects the company's commitment to transformative science [10][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in returning to growth in 2025, supported by new product launches and a strong pipeline [7][26] - The company anticipates challenges in the second half of the year, particularly with Gardasil in Japan and China [28] Other Important Information - The company is conducting over 80 phase three studies across various therapeutic areas, indicating strong clinical momentum [8] - The FDA approved Inflonsia for RSV prevention in infants, marking a significant milestone for the company [9] Q&A Session Summary Question: Context for Cadence outcomes - Management indicated that the most important signal for success in the Cadence study is the PVR, with the six-minute walk also being significant [51][52] Question: Ex-US uptake of Winrevir - Management noted that growth in the ex-US market is expected to accelerate in the second half of the year, with recent approvals in Japan [61][62] Question: Impact of $3 billion restructuring - Management clarified that the $3 billion will be reinvested into high-potential areas, with a focus on funding the pipeline and commercial launches [67][69] Question: Gardasil demand dynamics - Management expressed confidence in Gardasil's safety and efficacy, but noted challenges in the CDC purchasing dynamics and soft demand in China [72][78] Question: Valuation for Chinese partner Lenovo - Management confirmed that the Lenovo program is progressing as planned, with no issues reported [88][89]