Company Leadership & History - Dave Ricks has been at Eli Lilly and Company for 20% of its 150-year history [1] - Dave Ricks provided a 2-hour overview of the pharmaceutical industry [1] Pharmaceutical Industry Overview - Discussion covered drug prices, clinical trials, patent clocks, the rise of generics, Chinese peptides, and compounding pharmacies [1] - The US healthcare system was discussed [1] Business Transformation - The broad success of GLP-1s has transformed Lilly's business [1] - New pharma business models are being explored [2] Research & Development - R&D decision-making processes were discussed [2] - Stimulating more R&D is a key topic [2] Strategic Initiatives - LillyDirect was mentioned [2] - Investors' interest in LLY was discussed [2]

Financial Performance - Total operating expenses for Q3 2025 were $23018 thousand, compared to $9740 thousand in Q3 2024[16] - R&D expenses for Q3 2025 were $10307 thousand[16] - G&A expenses for Q3 2025 were $12711 thousand[16] - Net loss for Q3 2025 was $21690 thousand, compared to a net loss of $8679 thousand in Q3 2024[16] - The company's cash, liquidity fund, time deposits, and U S treasury bills totaled $2756 million[16] - Total operating cash outflow for the third quarter was approximately $93 million, compared to $86 million in the second quarter[16] Pipeline and Regulatory Updates - The company completed a $15 million registered direct offering and a $125 million private placement, with potential for an additional $165 million upon full warrant exercise[13] - The pivotal phase 3 DRAGON trial in Stargardt disease (STGD) has been completed, with topline data expected in Q4 2025[13] - China's NMPA has agreed to accept a New Drug Application with priority review for Tinlarebant for the treatment of Stargardt disease based on interim analysis results of the DRAGON trial[13] - The United Kingdom's MHRA has agreed to accept a Conditional Marketing Authorization application for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results of the DRAGON trial[13]

Business Highlights - Roivant anticipates an NDA filing for brepocitinib in dermatomyositis (DM) in the first half of 2026 [14] - Positive Phase 3 VALOR study results for brepocitinib in DM showed statistically significant benefit on all 10 ranked endpoints [13] - Durable remission data in Graves' disease (GD) and positive Phase 3 batoclimab data in Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) were unveiled [13] - A favorable Markman ruling was issued for Genevant in the Pfizer case [13] Pipeline Progress - Registrational trials have been initiated in GD, MG, CIDP, Difficult-to-Treat Rheumatoid Arthritis (D2T RA), and Sjögren's disease (SjD); a Proof of Concept (POC) trial has been initiated in Cutaneous Lupus Erythematosus (CLE) [13] - The company is focusing on clinical trial execution to drive significant potential value, with 11 registrational trials in indications with blockbuster potential [18] - In the VALOR study, brepocitinib 30 mg showed a mean Total Improvement Score (TIS) of 46.5, a delta of >15 points (p=0.0006) relative to placebo at week 52 (TIS of 31.2) [24] - Approximately 50% of responders in the batoclimab Graves' disease study achieved Anti-Thyroid Drug (ATD)-free remission at Week 48 [61] Financial Status - Roivant reported a strong capital position with $4.4 billion in cash balance as of September 30, 2025 [13, 73] - Research and Development (R&D) expense was $165 million, with an adjusted R&D expense of $153 million (non-GAAP) for the three months ended September 30, 2025 [73] - General and Administrative (G&A) expense was $143 million, with an adjusted G&A expense of $72 million (non-GAAP) for the same period [73]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was reported at $54.5 million, with product revenue net at $51.9 million, an increase from $49.2 million in Q2 2025 but a decrease from $56.1 million in Q3 2024 [5][20][27] - Net income based on GAAP for Q3 2025 was $8.8 million, or $0.18 per basic share, compared to $5.9 million, or $0.12 per share in Q2 2025 [25] - Non-GAAP net income for Q3 2025 was $10.5 million, or $0.21 per share, reflecting an increase from the previous quarter [26] - Gross-to-net adjustment in Q3 2025 was approximately 25.9%, up from 20.8% in Q2 2025, primarily due to higher Medicare rebates [27] Business Line Data and Key Metrics Changes - Product revenue from Nerlynx sales was $51.9 million in Q3 2025, up from $49.2 million in Q2 2025 but down from $56.1 million in Q3 2024 [5][20] - Royalty revenue decreased to $2.6 million in Q3 2025 from $3.2 million in Q2 2025 and $24.4 million in Q3 2024 [6][27] - Total prescriptions for Nerlynx declined approximately 1% compared to Q2 2025 and 4% year over year [22] Market Data and Key Metrics Changes - U.S. net sales of Nerlynx in Q3 2025 were $51.8 million, compared to $48.8 million in Q3 2024 [27] - The specialty pharmacy channel accounted for about 65% of the business, while the specialty distributor channel made up 35% in Q3 2025 [19] Company Strategy and Development Direction - The company is focused on expanding its market presence for Nerlynx and enhancing clinical education through marketing initiatives [15][16] - Ongoing clinical trials for alisertib are being prioritized, with a focus on identifying biomarkers that may predict better outcomes [10][11] - The company is evaluating potential acquisitions to diversify its portfolio and leverage existing infrastructure [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving positive net income for the full year 2025, driven by disciplined financial management [34][35] - The company anticipates a demand increase for Nerlynx in the U.S. for the first time since 2018 [34] - Future guidance includes expectations for net product revenue in Q4 2025 to be between $54 million and $56 million [30] Other Important Information - The company reported cash burn of approximately $1.6 million in Q3 2025, with total outstanding principal debt decreasing to about $33 million [32] - Anticipated R&D expenses are expected to increase by 20-25% year over year due to faster enrollment in clinical trials [32] Q&A Session Summary Question: What is the evaluation bar for alisertib in combination with endocrine therapy? - Management indicated that the previous trial TBCRC41 will serve as a comparison for efficacy, focusing on the third-line treatment space for HER2-negative breast cancer [38][39] Question: Would the company consider going negative with data if it supports a pivotal program? - Management noted that while they aim to remain profitable, they are open to staggered spending on indications to control cash burn [40][41] Question: Will a pivotal phase three trial require a partner? - Management stated that they do not anticipate a large trial and believe it can be managed within their financial framework, especially as debt is paid down [42][43]

Financial Data and Key Metrics Changes - Total revenue increased by 11% in the first nine months of 2025, driven by strong demand for innovative medicines [6][11] - Core EPS rose by 15%, reflecting robust underlying business momentum [14] - Product sales grew by 9%, while alliance revenue surged by 41% [11][12] - Core gross margin was reported at 83%, with expectations of a slight decrease for the full year due to various factors [12][15] - Operating cash flow increased by 37% to $12.2 billion [14] Business Line Data and Key Metrics Changes - Oncology franchise revenue grew by 16%, with TAGRISSO sales reaching $1.9 billion, marking a 10% increase [17][18] - Biopharmaceuticals revenue rose by 8%, with significant growth in newer medicines offsetting losses from mature brands [7][31] - Rare disease medicines grew by 6%, with Ultomiris and Strensiq showing strong demand [40][41] Market Data and Key Metrics Changes - U.S. revenues increased by 11%, while emerging markets outside of China saw a 21% growth [7] - The U.S. is projected to account for around 50% of total revenue by 2030 [9] - China experienced strong growth throughout the year, although fourth-quarter revenues are expected to be impacted by specific costs [15][16] Company Strategy and Development Direction - The company aims for an $80 billion revenue target by 2030, supported by a rich pipeline of upcoming product launches and regulatory approvals [8][45] - AstraZeneca is expanding its global manufacturing capacity and enhancing its clinical trial footprint in the U.S. [9][10] - The company is focusing on advancing novel therapies into earlier-stage diseases to improve patient outcomes [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the agreement with the U.S. government regarding pricing and innovation sustainability [49] - The company anticipates continued strong revenue momentum in growth brands, despite potential headwinds from product exclusivity losses [15][52] - Management highlighted a unique catalyst-rich period extending through 2026, with significant revenue opportunities from upcoming readouts [45][46] Other Important Information - The company has achieved 31 regulatory approvals across key regions in 2025 [6] - A new facility in Virginia has been established to support manufacturing capacity [10] - The company is harmonizing its listing structure across major stock exchanges to enhance capital access [10] Q&A Session Summary Question: What is the risk of residual activity from the administration regarding pricing? - Management indicated that they have addressed key points in the president's letter and do not expect further issues, expressing confidence in the agreement with the U.S. government [49] Question: Is the $10 billion catalyst potential part of the $80 billion target? - Management clarified that the $10 billion is a peak-year revenue number and contributes to the $80 billion target, with additional readouts expected to add further revenue potential [50] Question: What is the comfort level regarding 2026 margin consensus? - Management noted that while there are pushes and pulls affecting the 2026 margin, they remain committed to investing in growth brands and maintaining strong operating leverage [52][53] Question: Can you discuss the potential impact of the CARDIO-TTRansform study? - Management expressed optimism that the study could meaningfully reshape treatment guidelines for patients with ATTR amyloidosis [62] Question: What are the competitive profiles for the obesity portfolio? - Management is advancing multiple molecules in the weight management portfolio and is focused on developing competitive treatment options [68]

November 6, 2025 Q3 2025 Results Clinical Trial Appendix Disclosures Certain statements contained in this presentation and in any accompanying oral presentation, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Examples of such forward-looking statements include statements regarding BeOne's research, discovery, pre-clinical and clinical programs and plans. Actual results may differ materially from those indicated in the forward- l ...

Financial Data and Key Metrics Changes - For Q3 2025, net revenue from continuing operations was $8.3 million, with year-to-date revenues totaling $30.9 million, reflecting a 12% growth compared to the same period last year [10][23] - The adjusted loss for Q3 was $0.8 million, or $0.06 per share, while year-to-date adjusted earnings were $1.9 million, or $0.13 per share [10][23] - Cash flow from operations increased to nearly $5 million through September 2025 [10][23] Business Line Data and Key Metrics Changes - Revenue breakdown for Q3 2025 included $1.2 million for Kristalose, $3.2 million for Sancuso, $2.6 million for Vibativ, and $0.9 million for Caldolor [23] - Year-to-date product revenues were $7.4 million for Kristalose, $8.6 million for Sancuso, $6.7 million for Vibativ, and $3.8 million for Caldolor [23] Market Data and Key Metrics Changes - The company launched Vibativ in Saudi Arabia and received regulatory approval for ibuprofen injection in Mexico, expanding its international presence [8][9] - Vibativ was added to a national purchasing agreement with Premier Inc., enhancing its market accessibility [15] Company Strategy and Development Direction - The company entered a joint commercialization agreement with RedHill Biopharma for Talicia, a treatment for H. pylori infections, which is expected to contribute significantly to revenue [5][6] - The company is focused on expanding its portfolio of FDA-approved brands and enhancing its clinical pipeline, particularly with the Ifetroban product candidate [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's future, highlighting the addition of new products and the expected momentum across approved brands [28] - The company anticipates increased international contributions and further progress in its clinical pipeline [28] Other Important Information - The company reported total assets of $66 million, including $15 million in cash, and total liabilities of $40 million at the end of Q3 [11][25] - The company continues to hold over $53 million in tax net operating loss carryforwards [26] Q&A Session Summary - There were no questions during the Q&A session, and management encouraged shareholders to reach out for private discussions if desired [31][32]

Financial Performance - Total revenue reached $17601 million, a 54% increase compared to Q3 2024[12, 17] - Key product revenue grew by 104%, reaching $12 billion[12] - Non-GAAP earnings per share (EPS) increased by $584 to $702[12] - The company raised the midpoint of full-year revenue guidance by over $2 billion[10] Product Highlights - Lilly's U S incretin analogs market share increased to 579% of total prescriptions, with market growth of 36% versus prior year[10, 26] - Mounjaro U S sales were $36 billion, and international sales were $30 billion[56] - Zepbound U S sales were $36 billion, and international sales were $20 million[59] - Verzenio U S sales were $880 million, and international sales were $590 million[62] - Jaypirca Q3 2025 sales were $143 million, with U S TRx increasing 61% vs Q3 2024[24] - Ebglyss Q3 2025 sales were $127 million, with U S TRx growing 41% vs Q2 2025[24] - Omvoh Q3 2025 sales were $65 million[24] - Kisunla Q3 2025 sales were $70 million[24] Strategic Investments - Year-to-date capital investments totaled $53 billion[12] - Research & Development investment was $35 billion, representing 27% of revenue[12] - Marketing, selling & administrative expenses were $27 billion, a 31% increase[12] - $13 billion was distributed via dividends and $07 billion in share repurchases[14] Regulatory and Clinical Updates - Inluriyo (imlunestrant) received U S FDA approval for ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer[11] - Kisunla received marketing authorization in Europe for early symptomatic Alzheimer's disease[11] - Orforglipron showed positive results in four additional Phase 3 trials[11] - Jaypirca significantly improved progression-free survival in treatment-naïve CLL/SLL[11]

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Financial Data and Key Metrics Changes - Regeneron reported total revenues of $3.8 billion for Q3 2025, reflecting a 1% increase compared to the prior year, driven by higher collaboration revenue from Sanofi and growth in net sales of Dupixent and Libtayo, partially offset by lower EYLEA sales [39][40] - Diluted net income per share was $11.83, with net income reaching $1.3 billion [39] - Gross margin on net product sales was 86%, lower than the previous year due to a changing product mix and increased investments in manufacturing operations [41] Business Line Data and Key Metrics Changes - Dupixent achieved worldwide net sales of $4.9 billion in Q3 2025, a 26% increase on a constant currency basis compared to the prior year, with U.S. sales growing 28% to $3.6 billion [35][39] - Libtayo's global net sales were $365 million, up 24% year-over-year on a constant currency basis, with U.S. sales growing 12% [36][39] - EYLEA HD U.S. net sales reached $431 million, an all-time high, while EYLEA sales decreased 10% to $681 million due to competitive dynamics and patient affordability issues [10][32] Market Data and Key Metrics Changes - Dupixent is positioned to address over 4 million patients in the U.S., with more than 1.3 million patients currently being treated globally [8] - Libtayo is the market leader in advanced non-melanoma skin cancers and has recently been approved for high-risk adjuvant cutaneous squamous cell carcinoma, with an estimated 10,000 eligible patients in the U.S. [9][37] - EYLEA HD now represents approximately 40% of Regeneron's U.S. retina franchise, with expectations for moderate to high single-digit demand growth in the upcoming quarter [32] Company Strategy and Development Direction - Regeneron is focused on maximizing growth from existing brands while launching new products and indications, with significant investments in R&D to support its innovative pipeline [16][39] - The company is engaged in discussions with the U.S. government to lower drug costs while preserving innovation and has committed to investing over $7 billion in infrastructure and manufacturing facilities [15][39] - The pipeline includes advancements in immunology, oncology, and rare diseases, with multiple positive Phase III data readouts expected to drive future growth [12][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing discussions with the U.S. government regarding drug pricing and the importance of equitable global systems for innovation [14][15] - The company anticipates continued growth across its commercial portfolio, particularly from Dupixent, Libtayo, and EYLEA HD, while preparing for upcoming label enhancements [16][32] - Regeneron expects a mid-teens percentage increase in R&D expenses in 2026 to support its innovative pipeline [43] Other Important Information - The FDA issued a complete response letter for EYLEA HD's prefilled syringe supplemental BLA due to unresolved inspection findings at a contract manufacturing facility [11] - Regeneron has made significant progress in its clinical trials for various programs, including a promising Phase III trial for a treatment addressing fibrodysplasia ossificans progressiva [30] Q&A Session Summary Question: Changes in EYLEA's commercial strategy and pricing - Management acknowledged competitive issues and emphasized the importance of EYLEA HD's clinical efficacy and safety in driving its performance [45][48] Question: Future manufacturing expansion plans - Management indicated openness to using the balance sheet for large deals if the right opportunity arises and highlighted ongoing investments in domestic manufacturing [54][56] Question: Importance of label enhancements for EYLEA HD - Management noted that label enhancements are crucial for providing dosing flexibility and improving market share [59][60] Question: Insights from previous IL-33 trials for COPD - Management refrained from commenting on specific insights but mentioned upcoming discussions with the FDA to guide future strategies [63][64] Question: Probability of approval for RVO and four-week dosing filing - Management discussed the complexities of the approval timeline and the need for the new filler to undergo review before resubmission [66][68] Question: Changes to regulatory manufacturing teams to prevent CRLs - Management clarified that issues were not due to internal regulatory problems but rather manufacturing challenges, emphasizing the need for their own filling capabilities [72][74] Question: Factor XI antibody program and future opportunities - Management highlighted the focus on understanding the benefit-risk ratio for their antibodies and the potential for broader applications beyond current indications [78][80]