Core Insights - Stonegate Capital Partners has updated its coverage on Incannex Healthcare Inc. (NASDAQ: IXHL), highlighting significant clinical progress in the development of IHL-42X for obstructive sleep apnoea (OSA) [1][7] Clinical Development - In Q4 2025, Incannex reported that IHL-42X achieved statistically significant reductions in the Apnoea-Hypopnoea Index (AHI), with maximum reductions of up to 83% in the high-dose group and 79% in the low-dose group [1][7] - Exit interviews indicated that 57.6% of participants perceived an improvement in their OSA, with many describing the changes as meaningful to their daily lives, including better sleep quality and reduced fatigue [1][7] - IHL-42X was well tolerated, with no serious adverse events reported, suggesting its potential for broad use upon approval [1][7] Financial Overview - As of the quarter-end, Incannex reported cash reserves of $73.3 million, a net loss of $6.4 million, and operating expenses of $6.8 million, providing at least twelve months of financial runway [7]

Summary of United Therapeutics Conference Call Company Overview - **Company**: United Therapeutics (NasdaqGS: UTHR) - **Event**: Jefferies Linden Healthcare Conference 2025 - **Date**: November 18, 2025 Key Points Current Commercial Business - **Revenue Growth**: United Therapeutics reported significant growth in total revenue, particularly from Tyvaso and Tyvaso DPI, which are expected to be the main growth drivers moving forward [4][6] - **Tyvaso DPI**: The product has no dosing limitations, is well-received by prescribers and patients, and has a favorable product profile, including ease of use [5][6] - **Market Position**: The company believes it is well-positioned in the pulmonary space, with a strong understanding of the market dynamics [4][6] Competitive Landscape - **Utrepia Launch**: Despite the launch of Utrepia, a competing product, United Therapeutics has seen a return in referrals and start trends towards Tyvaso, indicating strong market positioning [11][12] - **Market Expansion**: The presence of more therapies in the market is expected to expand the overall patient population rather than create a zero-sum game [13][14] Litigation Concerns - **Ongoing Litigation**: The company is awaiting a ruling on litigation related to Utrepia but remains confident in its growth trajectory regardless of the outcome [15][17][18] Future Projections - **Revenue Target**: United Therapeutics aims for a quarterly revenue run rate of $1 billion by the end of 2027, primarily driven by existing commercial products [19][21] - **IPF Opportunity**: The company sees a significant market opportunity in idiopathic pulmonary fibrosis (IPF), with an estimated 100,000 patients in the U.S. and a multi-billion dollar market potential [25][34] Clinical Trials and Pipeline - **Teton Trials**: The Teton 2 trial for IPF showed promising results, and there is high conviction that these results will translate to the Teton 1 trial in the U.S. [28][31] - **Regulatory Strategy**: The company plans to meet with the FDA to discuss the approval process for Tyvaso in IPF, aiming to expedite market entry [32][33] Additional Opportunities - **PPF and Rilendipag**: The company is optimistic about the potential for Tyvaso in pulmonary fibrosis (PPF) and is conducting trials for Rilendipag, an oral therapy expected to read out in 2026 [36][38] - **Xenotransplantation**: United Therapeutics is exploring organ transplantation, having conducted its first kidney transplant in a clinical trial, with plans to expand into lung and heart transplants [43][44] Financial Position and Strategy - **Overall Strategy**: The company is confident in its commercial pipeline and long-term organ manufacturing strategy, indicating a strong financial position [46][47] Conclusion United Therapeutics is positioned for significant growth driven by its existing products, promising clinical trials, and strategic market expansion. The company remains optimistic about its future revenue targets and the potential impact of its innovative therapies in the pulmonary and transplant markets.

Research Disruption - Federally funded clinical trials experienced disruption affecting over 74,000 patients [1] - National Institutes of Health terminated billions of dollars in research grants [1] Funding Impact - Hundreds of clinical trials were disrupted due to grant terminations [1]

Core Insights - Innate Pharma S.A. is a prominent biotechnology company specializing in therapeutic antibodies for cancer and other diseases, with notable products like Lacutamab and Monalizumab, and strategic partnerships with AstraZeneca and Sanofi [1] Price Target Analysis - The average price target for Innate Pharma's stock has risen from $3.5 to $5 over the last quarter, indicating a positive sentiment among analysts [2][6] - Three months ago, the average price target was $3.5, reflecting a significant increase linked to advancements in clinical trials or new collaborations [3] - A year ago, the average price target was also $3.5, showing stability, but recent developments have led to a more optimistic outlook from some analysts [4] Analyst Perspectives - Analysts have identified a hammer chart pattern, suggesting potential support for the stock after a decline and indicating a possible trend reversal [2][6] - Despite the overall positive trend, analysts from Leerink Partners have set a more conservative price target of $2, indicating differing views on the stock's future [3][6] Future Developments - Investors are advised to monitor upcoming announcements regarding clinical trial results or new partnerships, as these could significantly influence the stock's target price and market perception [5]

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 ...