Financial Performance - Group revenue declined by 360% year-over-year to $630 million due to US health program budget pressures, regulatory challenges, and evolving market dynamics[23, 29] - Gross profit decreased by 385% year-over-year to $329 million[29] - The company recognized a non-cash impairment of $465 million on US intangibles[23] - EBITDA was down by $139 million year-over-year, reaching ($107 million)[29] Strategic Decisions and Capital Position - The ANZ business was divested post year-end to Jonas Software for $350 million, with potential earn-outs of up to $735 million over three years[23] - As of July 9, the company had a net cash position of $165 million, excluding an $8 million holdback, and all debt was extinguished[23] - The company withdrew its FY26 revenue guidance due to prevailing short-term market uncertainty in the US[24] US Market Operations - US revenue declined by 360% year-over-year, mirroring the group's overall revenue decrease[39] - THRiV-powered programs contributed 31% of US revenue in FY25, exceeding the PCP (Prior Corresponding Period)[40] - The US program pipeline is valued at US$125 million (unweighted) heading into 1H FY26[24, 58] - Operating costs for continuing operations are expected to decrease by 10% in FY26 compared to FY25 due to right-sizing efforts[24, 59]

Summary of Syndax Pharmaceuticals (SNDX) Conference Call - September 02, 2025 Company Overview - **Company**: Syndax Pharmaceuticals - **Products**: Revuforj (for KMT2A-rearranged acute leukemia) and Ictimo (for chronic graft-versus-host disease, cGVHD) - **Recent Achievements**: Two rapid approvals in succession, with a focus on addressing high unmet medical needs in oncology Key Points on Revuforj - **Launch Performance**: Revuforj has seen a **43% growth in net sales** with over **$50 million** generated since launch, treating over **500 patients** [3][5] - **Market Dynamics**: - Targeting **KMT2A-rearranged patients**, with a total addressable market (TAM) of **2,000 new patients annually** [5][6] - Currently treating **25%** of the available market, with expectations to increase to **50%** by year-end [5][6] - **Treatment Duration**: Average treatment duration expected to increase from **4-6 months** to **9 months** as more patients are treated earlier in their disease progression [9][10] - **Patient Demographics**: Shift from treating late-line patients to earlier-line patients, with **70%** of current patients being in the second or third line of treatment [7][12] - **Transplant Dynamics**: Approximately **33%** of patients are expected to go for transplant, higher than the **25%** seen in clinical trials [7][8] Upcoming Regulatory Milestones - **sNDA Submission**: An sNDA for Revuforj is under review with a PDUFA date of **October 25, 2025** [21][22] - **Market Expansion**: The NPM1-mutated patient market is larger than KMT2A, with an estimated **4,500 patients** [23][24] Key Points on Ictimo - **Launch Success**: Ictimo has generated nearly **$50 million** in sales in its first full quarter, with **700 patients** treated [42][43] - **Patient Retention**: **80-90%** of patients are remaining on the drug, indicating strong tolerability [42] - **Market Coverage**: Over **80%** of transplant centers have utilized Ictimo, with a majority using it multiple times [43][44] - **Partnership with Incyte**: Co-promotion with Incyte has been efficient, leveraging their existing infrastructure [44] Future Development Plans - **Subcutaneous Formulation**: Development of a subcutaneous formulation for Ictimo is underway, which could enhance patient convenience [48] - **Clinical Trials**: Ongoing studies in combination with dexamethasone and Jakafi for earlier lines of therapy in cGVHD [49][50] Financial Outlook - **Profitability Goals**: Syndax aims to reach profitability without needing additional financing, with operating expenses expected to remain flat through **2025** [61][62] - **Collaboration Revenue**: Ictimo is already profitable on a contribution profit basis, with **$9 million** in collaboration revenue reported [61] Competitive Landscape - **Market Position**: Syndax is positioned as the only approved menin inhibitor, with a focus on maintaining a competitive edge through efficacy and multiple indications [30][40] Conclusion - **Strategic Focus**: Syndax is concentrating on successfully commercializing Revuforj and Ictimo, advancing clinical development, and achieving profitability before considering new product investments [68][69]

TEL AVIV, Israel, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that Richard Francis, Teva's President and CEO, will present at two upcoming investor conferences in September as follows: Morgan Stanley 23rd Annual Global Healthcare ConferenceTuesday, September 9, 2025, at 8:30 A.M. ET BofA Global Healthcare Conference 2025 (London)Wednesday, September 24, 2025, at 9:00 A.M. British Summer Time (4.00 A.M. Eastern Time) To access a live webcast of ...

Core Insights - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system cancers [2] - The company will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8 to 10, 2025 [1] - Dr. Marc H. Hedrick, President and CEO of Plus Therapeutics, will engage in a fireside chat at the conference, available on demand for registered investors starting September 5 [2] Company Overview - Plus Therapeutics is headquartered in Houston, Texas, and specializes in targeted radiotherapeutics aimed at difficult-to-treat CNS cancers [2] - The company is advancing a pipeline of product candidates, with lead programs targeting leptomeningeal metastases and recurrent glioblastoma [2] - Plus Therapeutics has established a supply chain through strategic partnerships to support the development, manufacturing, and potential commercialization of its products [2]

PresentationAt this time, I would like to turn the call over to Wade Walke, Senior Vice President of Investor Relations, to lead off the call. Please begin.Good morning, and welcome to Ionis Conference Call to discuss Olezarsen CORE and CORE2 top line data. As a reminder, this call is being recorded.D. WalkeSenior Vice President of Investor Relations Thank you, Ludy, and thank you to everyone who has joined us today as we discuss the groundbreaking top line results from the landmark CORE and CORE2 studies o ...

Core Viewpoint - A shareholder class action lawsuit has been filed against Biohaven Ltd. alleging misleading statements regarding the company's business and drug prospects [1] Group 1: Allegations in the Lawsuit - The lawsuit claims that Biohaven overstated the regulatory prospects of troriluzole as a treatment for spinocerebellar ataxia [1] - It is alleged that the efficacy and clinical prospects of BHV-7000 for bipolar disorder were also overstated [1] - The lawsuit suggests that the revelation of these issues could significantly negatively impact Biohaven's business and financial condition [1] Group 2: Shareholder Information - Shareholders who purchased Biohaven shares between March 24, 2023, and May 14, 2025, and experienced significant losses are encouraged to discuss their legal rights [2] - The deadline for shareholders to request to be appointed as lead plaintiff in the case is September 12, 2025 [3] - Holzer & Holzer, LLC is noted for its representation of shareholders in litigation and has recovered hundreds of millions for victims of corporate misconduct [3]

Core Insights - CorMedix's lead product, DefenCath, is the only FDA-approved antimicrobial catheter lock solution in the U.S. aimed at reducing catheter-related bloodstream infections in kidney failure patients undergoing hemodialysis [2][4][10] - DefenCath generated $78.8 million in net revenues in the first half of 2025, indicating a strong start in its commercial journey [4][10] - The product benefits from patent protection until 2033 and eligibility for reimbursement in the U.S. healthcare system, which supports its growth potential [4][5][10] Product and Market Position - DefenCath was approved by the FDA in late 2023 based on a phase III study showing a 71% reduction in the risk of CRBSI [2][3] - The product was launched commercially in April 2024 for inpatient settings and in July 2024 for outpatient hemodialysis [3] - CorMedix holds a unique market position as the only therapy for this niche condition, providing a long runway for revenue generation [4][10] Competitive Landscape - While CorMedix currently has a first-mover advantage, larger companies like Pfizer and Amphastar Pharmaceuticals could pose competitive risks if they enter the CRBSI prevention market [6][7][8] - Pfizer markets Heparin Sodium Injection, which has broad applications, and could pivot to CRBSI-specific indications [7] - Amphastar's vertically integrated model and manufacturing expertise present a competitive threat if they decide to target the same market [8] Financial Performance and Valuation - CorMedix's stock has surged 83.1% in 2023, outperforming the industry and the S&P 500 [9] - The stock is currently trading at a price/book ratio of 4.56, higher than the industry average of 3.09, indicating a potentially expensive valuation [11] - Earnings estimates for 2025 have improved from $1.10 to $1.49 per share, and for 2026 from $1.46 to $2.16 [14]

Core Insights - Bristol Myers (BMY) has a robust oncology portfolio featuring key drugs such as Opdivo, Opdivo Qvantig, and Yervoy, which are crucial for the company's growth strategy [1][9] - Opdivo's sales in the U.S. are significantly driven by its successful launch in MSI-high colorectal cancer and ongoing growth in first-line non-small cell lung cancer, while international sales are supported by volume growth [2] - The European Commission approved the subcutaneous formulation of Opdivo for multiple solid tumor indications, enhancing its market presence [3] - Opdivo Qvantig has also received approval for subcutaneous use, with strong initial uptake in the U.S. across all indicated tumor types [4] - BMY anticipates global sales for Opdivo and Qvantig to grow in the mid to high single-digit range in 2025, supported by strong performance in the first half of the year [5] Competitive Landscape - The immuno-oncology market is highly competitive, with Merck's Keytruda and Roche's Tecentriq being significant competitors. Keytruda accounts for approximately 50% of Merck's pharmaceutical sales [6] - Roche's Tecentriq is approved for various oncology indications and has also received approval for subcutaneous administration, further intensifying competition [7] Financial Performance and Valuation - BMY's shares have declined by 13.6% year-to-date, contrasting with the industry's growth of 4.3% [8] - The company is trading at a price/earnings ratio of 7.60x forward earnings, which is below the industry average of 14.78x, indicating a potential undervaluation [10] - The bottom-line estimate for 2025 has increased to $6.50 from $6.41, while the estimate for 2026 has slightly decreased to $6.07 from $6.08 [11]

Core Insights - Eli Lilly and Company (LLY) has significantly increased its market value over the past 2-3 years, primarily due to the success of its GLP-1 drugs, Mounjaro for type II diabetes and Zepbound for obesity [1] Drug Approvals and Revenue Contributions - Lilly has received approvals for several new drugs, including Omvoh for ulcerative colitis and Crohn's disease, Jaypirca for mantle cell lymphoma and chronic lymphocytic leukemia, Ebglyss for atopic dermatitis, and Kisunla for early symptomatic Alzheimer's disease, all contributing to revenue growth [2] - In the first half of 2025, Omvoh generated $111.9 million, while Ebglyss, Kisunla, and Jaypirca contributed $147.1 million, $70.1 million, and $215.3 million, respectively [3] Future Growth Potential - These drugs are being evaluated for additional indications and label expansions, with Ebglyss in phase III trials for perennial allergens and chronic rhinosinusitis, and Jaypirca being studied for earlier lines of therapy [4] - Lilly anticipates that Omvoh, Ebglyss, Kisunla, and Jaypirca will continue to drive revenue growth in the second half of 2025 [5] Upcoming Drug Approvals - A new drug, imlunestrant, is under review for treating ER+HER2-metastatic breast cancer in the US and EU [6] Competitive Landscape - Omvoh faces competition from AbbVie's Humira, Skyrizi, and Rinvoq, as well as J&J's Stelara, while Kisunla competes with Eisai/Biogen's Leqembi [7][8] - Jaypirca competes with older BTK inhibitors like Imbruvica and Calquence, and Ebglyss faces competition from Dupixent [9] Stock Performance and Valuation - Lilly's stock has declined by 4.6% this year, contrasting with a 1.3% increase in the industry [10] - The combined revenue from Omvoh, Ebglyss, Kisunla, and Jaypirca exceeded $540 million in H1 2025, with EPS estimates for 2025 and 2026 rising to $22.97 and $30.95, respectively [11] - Lilly's stock is currently trading at a price/earnings ratio of 25.87, higher than the industry average of 14.78, but below its 5-year mean of 34.54 [13] Consensus Estimates - The Zacks Consensus Estimate for 2025 EPS has increased from $22.04 to $22.97 over the past 30 days, while the estimate for 2026 has risen from $30.88 to $30.95 [14]

Core Insights - Corcept Therapeutics' sole-marketed drug, Korlym, has shown strong sales performance, with $351.6 million in sales for the first half of 2025, reflecting a year-over-year increase of approximately 13.2% [1][9] - The company anticipates full-year 2025 Korlym sales to reach $857.1 million, indicating a nearly 27% increase year-over-year [1][3] - Management expects a significant rise in Korlym prescriptions in the second half of 2025 as vendor issues are resolved [2][3] Sales and Revenue Expectations - Korlym sales were impacted by vendor capacity issues in Q1 2025 but improved in Q2, with expectations for continued growth in H2 2025 [2][3] - Corcept projects total revenues for 2025 to be between $850 million and $900 million [3] Pipeline Developments - Corcept is developing relacorilant for Cushing's syndrome, with a new drug application submitted to the FDA, and a decision expected by December 30, 2025 [4][9] - Approval of relacorilant is anticipated to broaden the patient base and reduce reliance on Korlym for future growth [5] Additional Indications and Studies - The company is also pursuing relacorilant for other indications, including a combination therapy for platinum-resistant ovarian cancer and adrenal cancer [6][7] - The BELLA study is evaluating the efficacy of relacorilant combined with nab-paclitaxel and Avastin for ovarian cancer treatment [7] Market Performance and Valuation - Corcept's stock has increased by 38.3% year-to-date, outperforming the industry average of 8.3% [8] - The company's shares are trading at a premium, with a price-to-sales ratio of 11.73 compared to the industry average of 2.38 [10] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has decreased from $1.39 to $1.15, and for 2026, it has decreased from $2.08 to $1.71 [11]