Financial Data and Key Metrics Changes - For Q3 2025, the company reported net revenues of $191.8 million, a slight increase from $191.2 million in the previous year [10] - GAAP net income was $17.3 million, or $0.37 per diluted share, down from $40.4 million, or $0.78 per diluted share in Q3 2024 [15] - Adjusted net income decreased to $44.6 million, or $0.93 per diluted share, compared to $49.6 million, or $0.96 per diluted share in the prior year [15] - Gross margins declined to 51.4% from 53.3% in the previous year's period [12] Business Line Data and Key Metrics Changes - Vaccimi sales reached $53.6 million, up 14% year-over-year from $40.4 million [10][11] - Primatene Mist sales increased by 11% to $28.8 million from $26.1 million [10] - Glucagon injection sales fell 49% to $13.6 million due to decreased unit volumes and increased competition [11] - Epinephrine sales decreased 12% to $18.8 million, while lidocaine sales dropped 19% to $12.9 million [11] - Other pharmaceutical product sales rose to $64.1 million from $58.3 million, driven by increased albuterol sales and the launch of iron sucrose injection [11] Market Data and Key Metrics Changes - The company is positioned to capture a combined market opportunity of over $60 billion with its newly added assets in oncology and ophthalmology [5] - The market for wet age-related macular degeneration and diabetic macular edema is valued at $9.4 billion [5] Company Strategy and Development Direction - The company is focused on a vertically integrated strategy and expanding its proprietary pipeline, aiming for proprietary products to comprise 50% of its pipeline by 2026 [6] - A significant expansion in US manufacturing capacity is planned to quadruple production at its Rancho Cucamonga headquarters [5] - The company is advancing its regulatory initiatives, including the FDA approval of iron sucrose injection, which is now commercially available [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving flat year-over-year revenue for the current year, with expectations of high single-digit to low double-digit growth for the next year [20] - The company is optimistic about the long-term growth potential of Vaccimi, forecasting peak sales of $250 million to $275 million [44] Other Important Information - The company has entered into an exclusive in-licensing agreement with Nanjing Anji Biotechnology for three early-stage peptide candidates [4] - A litigation provision related to a recent jury verdict has significantly impacted general and administrative expenses [13] Q&A Session Summary Question: Updated thoughts on year-over-year top line and growth for next year - Management believes they can achieve flat revenue this year and anticipates high single-digit to low double-digit growth next year [20] Question: Opportunity size for iron sucrose - The current run rate for iron sucrose is approximately $2.4 million, which is expected to stabilize [20] Question: Updates on AMP007 and FDA communication - Engagement with the FDA continues, with slight delays in interactions but no missed dates reported [23] Question: Competitive dynamics for generic Venofer - The company aims to launch iron sucrose with a profitable price portfolio and is adjusting guidance for next year based on risk [27] Question: Licensing with Nanjing Anji and business development appetite - The company is excited about the new peptide candidates and is looking for either commercialized or late-stage R&D assets in future deals [32] Question: Competitive landscape for insulin aspart - The company expects to face three or more competitors in the insulin aspart market but believes it will still be a significant opportunity [35] Question: Competition for Primatene Mist post-patent expiration - Management does not anticipate immediate competition for Primatene Mist but acknowledges the potential for generic entries [36] Question: Development path for in-licensed products - The new chemical products will follow the standard regulatory pathway, with some expected to have shorter paths to market [39]

Core Viewpoint - Tempus AI, Inc. reported strong third-quarter FY25 earnings, leading to a reiterated Buy rating from BTIG analyst Mark Massaro with a price target of $96, despite current selling pressure on the stock [1]. Earnings Details - Tempus AI reported revenue of $334.21 million, exceeding analyst estimates of $328.73 million, representing an 84.7% year-over-year increase [2]. - The adjusted loss per share was 11 cents, better than the estimated loss of 17 cents [2]. - For FY25, the company raised its revenue guidance to $1.265 billion from a previous estimate of $1.260 billion [2]. Analyst View - The analyst anticipates that Tempus will secure additional pharmaceutical contracts for its data and services business [3]. - There is an expectation for average selling prices (ASPs) to increase due to a shift towards higher-priced tests, such as the xT CDx priced at $4,500 per test (up from $2,900 for xT LDT) and the xF liquid biopsy assay at $3,288 per test (up from $2,919) [3]. - Expansion of commercial payor coverage for xF and xT CDx is expected, along with continued development of Tempus's algorithm business [3]. Market Positioning - Tempus is positioned at the intersection of key trends including precision medicine, oncology (including liquid biopsies), AI and machine learning, and the shift towards personalized drug development and companion diagnostics for pharmaceutical companies [4]. - As of the publication date, Tempus shares were down 2.74% at $82.18 [4].

Financial Data and Key Metrics Changes - For Q3 2025, total revenues were approximately $598 million, including Cabozantinib franchise net product revenues of approximately $543 million, which represents a year-over-year growth of about 14% from $478 million in Q3 2024 [5][12] - Gross-to-net for the Cabozantinib franchise was 30.4%, with expectations to maintain around 30% for the year [12] - GAAP net income for Q3 2025 was approximately $193.6 million, or $0.72 per share basic, and $0.69 per share diluted, while non-GAAP net income was approximately $217.9 million, or $0.81 per share basic, and $0.78 per share diluted [14][15] - Cash and marketable securities at the end of Q3 2025 were approximately $1.6 billion, with share repurchases totaling approximately $99 million during the quarter [15] Business Line Data and Key Metrics Changes - The Cabozantinib business showed strong performance, with net product revenues growing to approximately $543 million in Q3 2025, driven by robust demand and revenue growth [5][12] - The demand for Cabozantinib in neuroendocrine tumors grew about 50%, contributing approximately 6% of total business in Q3 2025, with expectations to exceed $100 million in revenue for this indication in 2025 [6][32] - Zanzalintinib is advancing with seven ongoing pivotal trials, focusing on expanding its indications and combinations, with positive results from the Stellar-303 trial in colorectal cancer [8][10] Market Data and Key Metrics Changes - Cabozantinib maintained its leadership position as the top TKI for renal cell carcinoma (RCC), with a greater than 40% new patient share in the oral second-line plus segment [5][6] - The Cabometyx business continued to grow, with TRX volume increasing by 21% in Q3 2025 compared to Q3 2024, outpacing the market basket growth rate of 13% [29] - The market for neuroendocrine tumors is viewed positively, with Cabometyx rapidly becoming the market leader in this segment, achieving over 40% new patient share for oral therapies [32] Company Strategy and Development Direction - The company aims to build a best-in-class, multi-franchise oncology business, focusing on improving the standard of care for cancer patients [4] - There is a strong emphasis on expanding the GI sales team to accelerate growth in the Cabozantinib neuroendocrine tumor indication and prepare for the Zanzalintinib launch [6][37] - The company is committed to managing capital allocation effectively while advancing R&D and commercial priorities, with plans to repurchase shares when undervalued [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance of the Cabozantinib business and the potential of Zanzalintinib to become a significant oncology franchise [4][8] - The company is optimistic about the regulatory approval process for Zanzalintinib, particularly following the positive results from the Stellar-303 trial [10][24] - Management highlighted the importance of the upcoming R&D day for sharing further details on pipeline developments and strategic initiatives [11][27] Other Important Information - The company announced a new share repurchase program totaling $750 million, authorized by the board, which will expire at the end of 2026 [15] - Susan Hubbard, EVP of Public Affairs and Investor Relations, announced her retirement, with Andrew Peters taking over her responsibilities [39][40] Q&A Session Summary Question: Summary of post-ESMO feedback on Zanzalintinib results - Management noted positive feedback from physicians regarding the overall survival benefit and the potential of Zanzalintinib as a chemo-free option in a fragmented market [42][44] Question: Rationale for using Sunitinib as a control in Stellar-304 - Management explained that Sunitinib is a standard of care in the setting and provides a relevant comparator due to its extensive use [49][50] Question: Expectations for the NLM cut from Stellar-303 - Management indicated that the study design allowed for a combined analysis, and results for the non-liver metastases subgroup are expected around mid-2026 [52][56] Question: Impact of Merck's LITESPARK-011 on Zanzalintinib - Management expressed confidence that ongoing trials with Merck will continue and emphasized the collaboration's potential [59][62] Question: Concerns regarding Stellar-303 trial approval - Management refrained from commenting on external opinions but maintained confidence in the trial's outcomes [64] Question: Strategy for NET population and potential cannibalization with Zanzalintinib - Management highlighted the distinct positioning of Zanzalintinib and the ongoing growth potential for Cabozantinib in the NET space [67][69]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $207.6 million, up from $182.5 million in the same period last year, reflecting a year-over-year increase of approximately 13% [3] - Net income decreased to $19.7 million from $47.2 million in Q3 2024 [3] - Cash and investments as of September 30, 2025, totaled $524 million, which includes a $50 million stock repurchase [3] Business Line Data and Key Metrics Changes - The hypercortisolism business experienced a 42.5% increase in tablet shipments compared to Q3 2024, driven by record prescriptions for Korlym [7] - The company is transitioning to a new pharmacy vendor due to capacity constraints with the previous vendor, which may affect growth in the short term [7][8] Market Data and Key Metrics Changes - The company reported around 3,250 paying patients at the end of Q3 2025, with expectations for significant market capacity growth as relacorilant is launched [34][35] - The authorized generic accounted for approximately 70% of the business in Q3 2025, with expectations to reach around 75% by year-end [42] Company Strategy and Development Direction - The company is preparing for the launch of relacorilant, with PDUFA dates set for December 30, 2025, for hypercortisolism and July 11, 2026, for ovarian cancer [12] - The oncology program is expanding significantly, with plans for new studies in various solid tumors and a focus on combining treatments with existing therapies [20][21] - The company aims to triple the potential patient base for gynecological cancers from 20,000 to 60,000 annually in the U.S. [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of relacorilant, anticipating it could generate $3-$5 billion in annual revenue in hypercortisolism alone within three to five years [11] - The company is optimistic about the upcoming FDA approvals and the potential impact of its clinical studies on treatment paradigms [28][29] Other Important Information - The company is finalizing a phase 3 trial design for dazcorilant in ALS, expected to start by mid-2026 [14][27] - The CATALYST study revealed that one in four patients with resistant diabetes has hypercortisolism, indicating a significant opportunity for treatment [24] Q&A Session Summary Question: How many patients were on drug at the end of the quarter? - Approximately 3,250 paying patients were reported at the end of Q3 2025 [34] Question: What is the capacity of the new pharmacy compared to the old one? - The new pharmacy has the ability to continually expand and has multiple locations, which is expected to support the business effectively [34] Question: Are there any downward pressures on margins? - No downward pressure on margins has been observed, and the company does not expect any [36] Question: What is the net pricing relative to brand pricing? - The net pricing is about a 30% discount to Korlym's list price, with the authorized generic making up a significant portion of the business [42] Question: Was the lack of priority review for the ovarian cancer NDA surprising? - Management was not surprised by the lack of priority review, acknowledging the FDA's many priorities [44] Question: What are the expectations for R&D and SG&A in 2026? - R&D expenditures are expected to remain stable, while SG&A expenses are anticipated to increase due to preparations for product launches [46]

Financial Performance - Total revenues for Q3 2025 increased by 11% year-over-year to $597.8 million[37], and 5% quarter-over-quarter[37] - Cabozantinib net product revenues were $542.9 million in Q3 2025[22] - GAAP net income for Q3 2025 was $193.6 million, a 64% increase year-over-year[37] - GAAP diluted earnings per share increased by 73% year-over-year to $0.69[37] - The company completed $689.6 million in stock repurchases through Q3 2025, with an additional $750 million SRP authorized through 2026[39, 40] - Full year 2025 total revenue guidance is $2.30 billion - $2.35 billion[41] Research and Development - Positive results were presented from the Phase 3 STELLAR-303 trial of zanzalintinib + atezolizumab in metastatic colorectal cancer (mCRC) at ESMO, with a statistically significant improvement in overall survival (OS) in the ITT population[16, 50] - The company intends to submit an NDA for zanzalintinib in CRC in December 2025[16, 50] - Enrollment was completed in Q2 2025 for the Phase 3 STELLAR-304 trial of zanzalintinib + nivolumab in 1L nccRCC, with top-line results anticipated mid-2026[65] - The Phase 3 STELLAR-311 study in advanced NET was initiated in Q2 2025[116] Commercial Performance - Cabometyx TRx market share reached approximately 46% in Q3 2025[88] - NET contributed approximately 6% to overall CABOMETYX Q3 volume[91] - CABOMETYX captured over 40% of new patient share of the small molecule segment in the 2L+ NET market[102, 104]

Summary of Radiopharm Theranostics Conference Call Company Overview - **Company Name**: Radiopharm Theranostics - **Ticker Symbols**: ASX (Australia), NASDAQ: RADX - **Founded**: 2021 in Australia - **Core Business**: Radiopharmaceutical imaging and therapies - **Management Team**: Primarily U.S.-based, located on the East Coast - **Public Listing**: Dual-listed on ASX and NASDAQ since December 2024 [2][4] Key Business Strategies - **Differentiation**: Focus on unique mechanisms of action in radiopharmaceuticals, avoiding common targets like PSMA, SSTR2, and FAP [3] - **Clinical Development**: Four therapeutic molecules and one imaging molecule currently in clinical stages [2][5] - **Supply Chain**: Established a secure and redundant supply chain, with strategic partnerships [4] Strategic Partnerships - **Lantheus**: Co-development agreement and largest shareholder (12% stake) [4] - **MD Anderson Cancer Center**: Joint venture for developing new radiopharmaceuticals [4][21] Product Pipeline - **RAD101**: Imaging agent for brain metastasis, currently in Phase IIB trials with 12 out of 30 patients enrolled. Expected completion by Q1 2026 [5][6][10] - **RAD204**: Therapeutic targeting PD-L1, in dose escalation trials, with promising early results [6][15] - **RAD202**: Therapeutic targeting HER2, also in dose escalation trials, showing significant tumor uptake [18][19] - **B7-H3**: Emerging mechanism for multiple solid tumors, IND approval received, expected to start Phase I soon [8][9] - **KLK3**: Prostate cancer drug using Tb-161 isotope, expected to start Phase I soon [9] Market Potential - **RAD101 Market Assessment**: Estimated total addressable market of $500 million to $700 million in the U.S. alone, with a projected market share of 94% due to lack of competition in brain metastasis imaging [26][27] - **Patient Population**: 300,000 new patients diagnosed annually with brain metastasis [10] Financials and Capital Raise - **Recent Capital Raise**: Conducted to extend cash runway into Q1 2027, following a previous raise in June 2024 [5][20] - **Cash Position**: Current cash runway is eight months, prompting the recent capital raise [20][27] Clinical Trial Updates - **RAD101**: Primary endpoint focuses on concordance with MRI, with secondary endpoints assessing additional lesion detection [23] - **RAD204 and RAD202**: Expected readouts in mid-2026 and end of 2026, respectively [25] Conclusion - **Outlook**: Positive early signals from clinical trials, with a strong focus on expanding the use of radiopharmaceuticals in oncology [25]

October 2025 Corporate Presentation Disclaimer This presentation (including any oral commentary that accompanies this presentation) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the planned completion of the transactions contemplated by the transaction ...

Financial Data and Key Metrics Changes - The company reported third quarter product sales of $7.3 billion, a 4% increase year over year and a 2% increase sequentially, driven by strength across the HIV portfolio, offset by lower oncology revenue [11][42] - Non-GAAP EPS grew 22% year over year, with a 10% increase excluding a $0.25 benefit from a non-recurring accounting item [5][43] - The company raised its full-year HIV revenue growth expectations to approximately 5%, up from 3% previously, despite a $900 million headwind from Medicare Part D redesign [5][46] Business Line Data and Key Metrics Changes - HIV sales reached $5.3 billion, representing a 4% growth year over year, primarily driven by higher demand and favorable inventory dynamics [12] - Biktarvy sales were $3.7 billion, up 6% year over year, achieving a record market share of approximately 52% in the U.S. [12][13] - Descovy sales increased to $701 million, a 20% year over year growth, with a record market share of over 45% for PrEP [14][15] - Libdelzi contributed to 12% year over year growth in the liver portfolio, exceeding $100 million in quarterly sales for the first time [7][20] Market Data and Key Metrics Changes - The PrEP market grew approximately 14% year over year, with Yes2Go achieving $39 million in third quarter sales and $54 million since its launch [15][18] - The company achieved 75% payer coverage for Yes2Go nearly three months ahead of target, setting a strong foundation for continued growth [6][18] Company Strategy and Development Direction - The company is focused on expanding its HIV portfolio and pipeline, with upcoming updates on next-generation HIV treatments expected before the end of the year [6][9] - The company plans to launch Trodelvy for first-line metastatic triple-negative breast cancer in 2026, following positive clinical trial results [8][34] - The company is actively seeking additional business development opportunities across liver disease and oncology [70][72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the HIV business, citing strong product leadership and an innovative pipeline [6][9] - The company anticipates continued growth driven by strong demand for Biktarvy and Descovy, despite challenges from Medicare Part D redesign [62][64] - Management highlighted the importance of access and reimbursement logistics for Yes2Go, indicating a gradual ramp-up in sales as practices integrate new coverage [76][90] Other Important Information - The company reported a third quarter operating margin of 50%, reflecting disciplined operating expense management [43] - The company returned $1.4 billion to shareholders in the third quarter, including $435 million in share repurchases [49] Q&A Session Summary Question: Insights on Yes2Go patient demographics and demand drivers - Management noted that Yes2Go is attracting a balanced mix of patients switching from existing therapies and new patients, with expectations for continued growth as market awareness increases [52][53] Question: Clarification on Yes2Go sales figures - Management provided context on the $39 million sales figure, indicating that it reflects true demand rather than inventory stocking, with a focus on achieving 75% coverage ahead of schedule [56][57] Question: Discussion on HIV treatment growth despite Medicare Part D impact - Management confirmed that strong growth in the HIV segment is driven by both treatment and prevention, with Biktarvy and Descovy leading the way [62][64] Question: Update on inventory impact for Yes2Go and CVS pricing discussions - Management clarified that there was no significant inventory buy-in during Q3, and discussions with CVS and other payers are ongoing to secure access [66][67] Question: Appetite for additional business development in liver-focused indications - Management expressed interest in pursuing additional late-stage assets in liver disease and other strategic areas, emphasizing a disciplined approach to business development [70][72]

Financial Performance - Total product sales excluding Veklury increased by 4% year-over-year to $7.1 billion[8], driven by the strength of the HIV portfolio[8] - Total HIV product sales also increased by 4% year-over-year[8], with Biktarvy up by 6%[8] and Descovy up by 20%[8], and Yeztugo sales of $39 million[8] - Non-GAAP diluted EPS was $2.47, or $2.22 excluding non-recurring revenue[8] - Livdelzi sales grew 35% quarter-over-quarter to $105 million[61] - Veklury sales decreased by 60% year-over-year due to fewer COVID-19 related hospitalizations[60], resulting in $400 million lower sales[60] Product and Pipeline Updates - Yeztugo achieved 75% payer access in the U S [8], with a target of 90% by the end of Q226[8] - The European Commission approved Yeytuo, a twice-yearly injection for HIV prevention[8] - Trodelvy sales increased by 7% year-over-year[8], driven by higher demand[34] - Cell Therapy sales decreased by 11% year-over-year[8] due to competitive headwinds[37] - The company expects HIV business to grow approximately 5% year-over-year, revised from a prior guidance of approximately 3%[17]

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