Key Takeaways Incyte (INCY) has put up a good performance in the past three months. Shares of the company have gained 9.2% against the industry's decline of 1.3%. The stock has also outperformed the sector in the said timeframe. INCY Outperforms Industry & Sector The outperformance can be attributed to positive pipeline and regulatory updates. Lead drug Jakafi (ruxolitinib) also maintains momentum. Let us take a look at what's happening with Incyte. Pipeline/Regulatory Updates Boost INCY Stock Last month, t ...

Jefferies Global Healthcare Conference June 5, 2025 Forward-looking Statements and Other Important Information This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding Karyopharm's beliefs about the market opportunity and annual peak revenue opportunities for selinexor; expectations with respect to commercialization efforts; the ability of selinexor to treat patients with multiple ...

Incyte (INCY) Update / Briefing June 15, 2025 06:00 AM ET Speaker0 UNIDENTIFIED in person here in the room. And a big thank you to all of you and specifically to our presenters today for the time and the energy you are putting behind this project. So the data we'll be speaking about September. The data that was presented today is the first clinical data presented with this product. And in fact, I was thinking of the ASH preclinical presentation that was a plenary session like two years ago, two point years ...

Summary of Karyopharm Therapeutics (KPTI) Conference Call Company Overview - **Company**: Karyopharm Therapeutics (KPTI) - **Key Products**: Selinexor (XPOVIO) - **Focus Areas**: Oncology, specifically multiple myeloma and myelofibrosis Key Points Commercial Performance and Product Dynamics - **Q1 Demand Growth**: KPTI reported a 5% year-over-year demand growth for XPOVIO in Q1, despite a one-time impact of $5 million from atypical returns related to high-dose selinexor [3][4] - **Real-World Utilization**: The company is focusing on increasing the utilization of selinexor in both community and academic settings, with a particular emphasis on lower doses [4][5] - **Community Treatment**: Selinexor is primarily used in the community setting for multiple myeloma patients, positioned in the second to fourth line of treatment [5][6] Growth Drivers and Future Outlook - **T Cell Engaging Therapies**: KPTI is generating data to support the use of selinexor in conjunction with T cell engaging therapies, which are becoming more prevalent in earlier treatment lines [9][10] - **Myelofibrosis Opportunity**: The ongoing SENTRI trial is evaluating selinexor in combination with ruxolitinib, with promising early data showing a 79% SVR 35 rate at week 24 compared to 30-35% for ruxolitinib alone [12][13][15] - **Durability of Response**: The company reported a 100% durability of response for patients achieving SVR 35 or TSS 50, indicating sustained benefits from treatment [17] Clinical Trials and Data - **Phase III Trials**: KPTI is focused on executing its Phase III trials for both myelofibrosis and endometrial cancer, with the latter leveraging a biomarker (p53 wild type) for patient selection [45][46] - **Endpoint Changes**: The transition from TSS 50 to absolute TSS is seen as a more sensitive measure for symptom improvement, gaining positive feedback from investigators and regulators [28][29] Safety and Tolerability - **Antiemetic Use**: KPTI has incorporated dual antiemetics in its Phase III trials to mitigate nausea and vomiting, achieving over 85% compliance and lower rates of these side effects [36][38] - **Safety Profile**: The safety profile of selinexor is evolving positively, with improvements noted in gastrointestinal side effects [17][38] Commercial Strategy - **Market Positioning**: KPTI aims to target all frontline myelofibrosis patients, leveraging existing commercial infrastructure to facilitate rapid uptake among physicians [41][42] - **Unmet Need**: Research indicates a significant unmet need in the myelofibrosis market, with 75% of physicians willing to adopt therapies that address key disease hallmarks [42] Financial Discipline - **Operational Focus**: KPTI is maintaining a disciplined approach to operational expenditures, concentrating resources on Phase III readouts and shutting down non-essential programs [48][49] Additional Insights - **Endometrial Cancer Landscape**: The company anticipates that selinexor will address a sizable unmet need in patients with p53 wild type tumors, with enrollment for the Phase III trial progressing well [46][47] - **Future Readouts**: KPTI is positioned for significant upcoming data readouts that could transform treatment paradigms in both myelofibrosis and endometrial cancer [49]

Core Viewpoint - Incyte Corporation reported strong first-quarter 2025 results, with adjusted earnings and revenues exceeding expectations, driven by the performance of its lead drug Jakafi and the launch of Opzelura [1][3][4]. Financial Performance - Adjusted earnings per share for Q1 2025 were $1.16, surpassing the Zacks Consensus Estimate of $1.01 and up from 58 cents in the same quarter last year [1]. - Total revenues reached $1.05 billion, a 20% increase year over year, exceeding the Zacks Consensus Estimate of $1 billion [1]. - Jakafi generated revenues of $709.4 million, a 24% increase from the previous year, driven by a 10% rise in paid demand, and also beating the Zacks Consensus Estimate of $661.1 million [3]. - Opzelura cream sales were $118.7 million, up 38% year over year, although it fell short of the Zacks Consensus Estimate of $127 million [4]. - Newly approved Zynyz generated $3 million in sales, significantly up from the previous year and exceeding the Zacks Consensus Estimate of $1.9 million [5]. Product Performance - Iclusig net product revenues were $29.5 million, down 3% year over year but above the Zacks Consensus Estimate of $28.7 million [5]. - Pemazyre sales were $18.4 million, reflecting a 4% year-over-year increase but missing the Zacks Consensus Estimate of $21.6 million [5]. - Minjuvi revenues totaled $29.6 million, a 24% increase year over year, but below the Zacks Consensus Estimate of $33.4 million [6]. - Axatilimab-csfr (Niktimvo) recorded $13.6 million in sales following its launch in Q1 2025 [7]. Guidance and Future Outlook - The company raised its 2025 Jakafi revenue guidance to a range of $2.95-$3 billion, up from the previous range of $2.93-$2.98 billion [15]. - Opzelura net product revenues are expected to be between $630-$670 million in 2025 [15]. - Adjusted research and development expenses are projected to be in the range of $1.78-$1.81 billion, while adjusted selling, general and administrative expenses are expected to be between $1.16-$1.19 billion [16]. Cash Position - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $2.4 billion, an increase from $2.2 billion as of December 31, 2024 [13].