The paragraph is an excerpt from a conference call during Incyte's Fourth Quarter 2024 and Full Year Financial and Corporate Update. Ben Strain, Associate Vice President of Investor Relations, begins the call by directing participants to relevant financial documents and warning about forward-looking statements. CEO Herve Hoppenot then discusses Incyte's financial performance, noting a 15% growth in total revenues to $4.2 billion in 2024. This growth was attributed to strong sales of Jakafi, which reached $2.8 billion, an 8% increase from the previous year, and a significant boost from Opzelura, demonstrating diversification beyond Jakafi.

In 2024, Opzelura experienced significant growth, increasing 50% to $508 million, driven by new patients, refills, and expanded reimbursement outside the US. The company's financial position remains strong, with $2.2 billion in cash and no debt, after completing a $2 billion share repurchase. The FDA approved Niktimvo, the first anti-CSF-1R antibody for chronic GVHD, now launched in the US. The sNDA for ruxolitinib cream for pediatric atopic dermatitis was filed with the FDA, with potential approval expected in late 2025. Additionally, approvals for tafasitamab and ratifamlimab are anticipated in the second half of 2025. These product launches are projected to contribute significantly to the company's revenue growth, with potential to generate $1 billion in incremental revenue by 2029.

In 2025, the company plans to launch four new products, utilizing its established commercial infrastructure for Jakafi, Opzelura, Monjuvi, and Pemazyre. Jakafi's fourth-quarter 2024 net revenue grew by 11% to $773 million, with a full-year increase of 8% to $2.8 billion, and a 10% rise in total patients, especially in polycythemia vera (PV), now representing 35% of Jakafi patients. They project Jakafi's 2025 revenue to be between $2.925 and $2.975 billion, with PV anticipated to become its largest contributor, supported by the MAJIC PV study. Opzelura's Q4 revenue grew by 48% to $162 million, driven by the US ($138 million) and international markets ($24 million), with full-year 2024 revenue up by 50% to $508 million. Growth was noted in atopic dermatitis (AD) and Vitiligo, both domestically and internationally.

The paragraph discusses Incyte's expectations for significant growth and important milestones in 2025. It anticipates net product revenue from Opzelura to reach $630-$670 million and sees 2025 as a pivotal year with meaningful milestones for all its programs, including four potential launches and three Phase 3 study initiations. The year is expected to be data-rich, with four pivotal data readouts and informative data from seven early-stage programs. The paragraph also mentions leadership changes, with Mohamed Issa replacing Barry Flannelly as the Executive Vice President, Head of U.S. Oncology. Lastly, Pablo Cagnoni reiterates the company's plan to deliver over ten high-impact launches by 2030.

In 2024, significant regulatory achievements were made, including the approval of Niktimvo for chronic graft-versus-host disease and three FDA submissions anticipated for approval later in the year. Data was disclosed from CDK2 and BET inhibitor programs, with plans for pivotal studies. At the ASH Annual Meeting, data was presented from the BET inhibitor program and Phase 3 results on tafasitamab in relapsed/refractory follicular lymphoma, which met its primary endpoint by improving progression-free survival. Tafasitamab was well tolerated, and FDA approval is expected in the second half of 2025. Additional data on the BET inhibitor showed positive results in reducing spleen volume and improving symptoms.

The paragraph outlines the advancement of a drug development program into Phase 3 as a monotherapy for the post-JAK population, with further details to be shared later in the year. It discusses the broad development plan for Povorcitinib, an oral JAK-1 inhibitor, which is in Phase 3 studies for several conditions, including hidradenitis suppurativa, vitiligo, and prurigo nodularis, with Phase 2 studies for chronic spontaneous urticaria and asthma expected to yield data by 2025. Povorcitinib has already demonstrated significant efficacy and safety in Phase 2 studies for hidradenitis suppurativa, showing rapid improvement in pain. Two Phase 3 studies, STOP-HS1 and STOP-HS2, are completed, with data expected in the first half of the year. The paragraph also details the mutant CALR monoclonal antibody program, which has potential to cure CALR mutated essential thrombocythemia or myelofibrosis and was recently highlighted in the journal Blood. Data from ongoing studies in ET and MF will be shared later this year. Lastly, it mentions ruxolitinib XR on Slide 21.

The paragraph announces that a bioequivalence study has shown the 55 mg extended-release formulation of ruxolitinib to be equivalent to the twice-a-day version. The company plans to seek FDA approval by the end of the year after completing stability studies. Incyte is aiming for an important year in 2025, with over 18 key milestones, including product launches and trial readouts, having already achieved two: launching Niktimvo and bioequivalence data for ruxolitinib. Financially, for 2024's fourth quarter, Incyte reported $1.2 billion in total revenues, a 16% increase, driven by strong product demand, particularly for Jakafi and Opzelura, and an increase in revenue from Monjuvi after acquiring full rights to tafasitamab.

In 2024, net product revenue increased by 8% compared to 2023, mainly due to a 7% rise in total demand and a 9% rise in paid demand, particularly after Medicare Part D patients returned to paid demand. Opzelura's revenue for the fourth quarter was $162 million, a 48% increase year-over-year, driven by growth in new patient starts and refills in the US and commercialization in Europe. The full-year revenue for Opzelura was $508 million, marking a 50% increase. Operating expenses increased due to higher R&D spending, which rose by 5% in the fourth quarter and by 14% for the full year, driven by investments in late-stage development assets. Future R&D expense growth may be controlled by reducing investments in completed or discontinued programs.

In the fourth quarter, Incyte's GAAP SG&A expenses rose 11% year-over-year due to Monjuvi-related sales and marketing expenses in the US following the acquisition of global rights and additional marketing activities. For the entire year 2024, these expenses increased by 7% due to recording new Monjuvi expenses and investing in the launch of Opzelura in Europe and preparation for new US product launches. Overall, total R&D and SG&A expenses rose 10% versus a 15% increase in total revenues, improving operating leverage and margins. For 2025, Incyte's guidance predicts Jakafi revenues between $2.925 and $2.975 billion, driven by demand growth in PV, with challenges from IRA-imposed price caps. Opzelura's revenues are expected between $630 million to $670 million, driven by demand in AD and vitiligo and potential growth from pediatric AD and expansion in Europe.

In the first quarter of the year, typical Q1 dynamics are expected to impact net sales, with Opzelura's net product revenue projected to be lower than the previous quarter due to deductibles resetting and the effects of holidays and events on dermatology product sales. Oncology product revenues are expected to range from $415 million to $455 million, including contributions from Iclusig, Miktimvo, Monjuvi/Minjuv, Pemazyre, and Zynyz, as well as upcoming launches of Monjuvi in FL and Zynyz in SCAC in the latter half of 2025. GAAP-based operating expenses are projected to increase, with COGS at 8.5% to 9% of revenues due to manufacturing costs and a profit-sharing agreement with Syndax. R&D expenses are anticipated to be between $1.93 billion and $1.96 billion, driven by pipeline progress, while SG&A expenses are expected to be $1.28 billion to $1.31 billion. Following these remarks, the company opens the floor for a Q&A session, and an unidentified analyst from Guggenheim Partners asks about expectations for an upcoming Phase 3 trial for Opzelura in prurigo nodularis, noting the lack of available topical therapies.

The paragraph discusses updates and plans for two medical programs. For the CDK2 program, pivotal trials will begin this year focusing on platinum-resistant ovarian cancer, using both single-arm and randomized trials. An update will be provided later in the year. Additionally, regarding the rux cream for prurigo nodularis, Phase 3 data is expected soon. If results are similar to Phase 2, which showed significant improvement in itching and safety, rux cream could be an important addition for patients with less severe disease.

In the paragraph, Tazeen Ahmad inquires about the guidance for Opzelura, focusing on the expected number of tubes used for its two approved indications and the criteria for clinically meaningful data for HS. Christiana Stamoulis responds, detailing that the guidance for Opzelura, set between $630 million to $670 million for the year, anticipates a 24% to 32% year-over-year growth. This growth is driven by demand for atopic dermatitis (AD) and vitiligo, with potential contributions from Opzelura's launch in pediatric AD and Europe. The guidance reflects variations in patient mix, activation rate, and adherence, especially for vitiligo, noting an increase in patients maintaining therapy and refilling prescriptions. More initiatives are planned to educate patients, which may influence future guidance.

In the paragraph, Herve Hoppenot discusses the expected trends in quarterly earnings, noting that the first quarter is usually lower than the previous and following quarters, as seen in past years and anticipated for 2025. He then addresses the importance of achieving positive study results, emphasizing the significance of statistical significance for the primary endpoint in the hidradenitis suppurativa studies involving Povorcitinib. He highlights the positive results from the Phase 2 study, including improvements in various efficacy measures and a favorable safety profile. Hoppenot expresses confidence in the competitiveness of Povorcitinib if Phase 3 results mirror those of Phase 2. Following this, an operator introduces a question from David Lebowitz, who inquires about the process for patients to ensure the implementation of the $2,000 out-of-pocket cap established by the IRA.

The paragraph features a discussion involving Christiana Stamoulis and Pablo Cagnoni in response to questions from David Lebowitz and Jessica Fye. Christiana Stamoulis explains that a new policy reducing the out-of-pocket cap to $2,000 annually allows patients to spread payments throughout the year, but understanding this process might take time, delaying sales benefits until later. Jessica Fye asks about the Phase 3 trials of a treatment named "povo" for HS, focusing on whether the trial includes biologic-naive patients and the study's statistical power. Pablo Cagnoni confirms the inclusion of both biologic-naive and biologic-experienced patients and mentions stratification criteria based on previous biologic exposure, noting that the trials are powered based on primary and key secondary endpoints. He defers detailed discussion until the results are available and future labeling discussions with the FDA.

In the discussion, Pablo Cagnoni clarifies that the focus for the Phase 3 study is on the 12-week data point, where the placebo-adjusted score for a certain metric was 28% at week 12 and 17% at week 16 during Phase 2 studies. This is important because the drug's quick action is significant for treating painful diseases like HS and PN. Cagnoni emphasizes that they aim to replicate the Phase 2 profile in Phase 3 without specifying exact numbers. Salveen Richter from Goldman Sachs then asks about the implications of the Phase 2 data drop from week 12 to 16 on the current trial and also inquires about the 2025 guidance related to Jakafi, particularly concerning Part D redesign modeling.

Herve Hoppenot discusses the variability and noise in clinical trials for HS, specifically noting a drop in the placebo-subtracted response in Phase 2, which they are not concerned about due to the study's robustness. They expect a statistically and clinically significant impact of their drug, povo, on the primary and secondary endpoints. Christiana Stamoulis addresses the impact of Medicare Part D redesign on the gross-to-net for Jakafi, highlighting savings from a change in the donut hole contribution but noting these will be offset by increases in 340B. James Shin from Deutsche Bank inquires about the disclosure of Phase 3 trial data for povo and updates on the X2 program for CSU.

In the article, Herve Hoppenot discusses plans for releasing data on povo for HS and a future update on program 262. When asked by Vikram Purohit from Morgan Stanley about proof-of-concept datasets for mutant CALR and JAK2V617F, Hoppenot explains that they expect to release significant data on mutant CALR for patients with essential thrombocythemia (ET) and myelofibrosis (MF) throughout the year. The goal is to provide information on various dose levels and important success measures, including traditional endpoints for Myeloproliferative Neoplasms and evidence of early reduction. Although the data may not be definitive, they aim to demonstrate promising early results.

The paragraph discusses updates on clinical trials and responds to questions from Marc Frahm. Pablo Cagnoni explains that the treatment of antibiotic use in the STOP-HS Phase 3 trial remains consistent with the Phase 2 trial. Patients cannot be on systemic antibiotics when they enter the study. If a patient starts antibiotics for a flare during the study, they are considered a non-responder; however, if antibiotics are started for unrelated reasons, it does not affect their responder status. Additionally, Christiana is asked to clarify growth assumptions for Opzelura, focusing on U.S. and international markets amid label changes and improving reimbursement outside the U.S.

Christiana Stamoulis discussed the global guidance for Opzelura, highlighting contributions from Germany and France in 2024, with Italy and Spain expected to join significantly in 2025. She noted that the specific contributions from different regions would not be broken down. Kelly Shi from Jefferies asked about the KRASG12D program, specifically regarding the sample size, tumor indications, and potential differentiation from competitors, as well as follow-up plans for povo. Herve Hoppenot responded that their focus is on pancreatic and colorectal cancer, aiming to expedite enrollment due to competitive pressures. He expressed confidence in the potential of their preclinical G12D inhibitor, suggesting that it could successfully compete, especially in early therapy lines when combined with chemotherapy, contingent on efficacy and safety outcomes.

The paragraph discusses the development and future plans for a BET inhibitor in treating myelofibrosis, particularly in settings where Jakafi monotherapy is no longer effective. It highlights the need for better treatment options for patients who progress after Jakafi. The company is accelerating the second-line program for the BET inhibitor and plans to disclose more information later in the year. For the first-line indication, they need additional data on safety and impact when combined with Jakafi in treatment-naive patients. They will also provide updates on this in the future.

In the article paragraph, a company executive discusses recent updates and future plans related to their BET inhibitor and Jakafi. They express optimism about the recent data presented at the ASH conference, highlighting the positive impact on spleen symptoms and hemoglobin levels. However, they acknowledge the need for additional data before further discussions with the FDA. Regarding ruxolitinib XR, they plan to submit a stability study to the FDA by the end of the year and aim to commercialize it by 2026. Their strategy includes transitioning patients to a once-daily dosage before generics arrive in 2029. The executive also mentions future plans for combining their BET inhibitor with other treatments, indicating that decisions are yet to be finalized.

The paragraph is an excerpt from a Q&A session during an investor call, where an unidentified analyst asks two questions on behalf of Eric Schmidt from Cantor Fitzgerald. The first question is about the expectations for high scores in a clinical study of povo in HS, questioning what would be considered meaningful and competitive data. Herve Hoppenot responds, indicating that statistical significance is key and that the results observed in Phase 2, such as a 20% improvement at week 12, are strong. The second question concerns the tafasitamab first-line study in DLBCL, asking about meaningful outcomes. Hoppenot emphasizes the significance of even small improvements in a curative setting, using recent data as a benchmark where modest improvement led to substantial adoption, indicating the potential for broad use in first-line therapy.

In this paragraph, Matt Phipps inquires about the learnings from the robust trial and the potential for success in their current trials, as well as the development plans for a mutant CALR program, including potential combinations with Jakafi. Pablo Cagnoni responds that while they haven't initiated a combination with Jakafi yet, it is a consideration because of Jakafi's rapid impact on patient symptoms. However, no definite combination plans have been decided. He notes differences in antibody affinity for Type 1 versus Type 2 CALR mutations, suggesting there may be varying levels of clinical activity for different mutation types, with more details to come once data is available.

The paragraph discusses a conversation between Andrew Berens and Herve Hoppenot regarding Jakafi XR, focusing on the challenges of achieving the Cmax with a once-daily formulation compared to a twice-daily one. It emphasizes meeting AUC and Cmin at steady-state, which have both been achieved, with stability studies being the last requirement for FDA resubmission. Andy Chen then inquires about povo HS, asking about protocol differences from IL-17 antibody trials and expectations for approval of different doses. Herve Hoppenot responds, noting the difficulty in detailing differences due to lack of information about competitors' protocols and mentioning that their Phase 3 study design has a higher percentage of certain patient groups compared to others.

The paragraph discusses efforts to minimize the placebo effect in a clinical trial for patients with advanced diseases by emphasizing careful site selection and consistent training, similar to Phase 2. The primary endpoint for Phase 3 was chosen based on Phase 2 results to ensure quick patient benefits by week 12. Potential discussions with the FDA regarding dosing might occur if both dose levels prove positive, potentially leading to a broader label. Additionally, Christiana Stamoulis provides guidance for Jakafi's projected growth in 2025, expecting a 5% to 7% increase compared to the previous year, noting that Q1 will likely be the lowest quarter due to deductible resets affecting commercial sales.

In the article's paragraph 26, an operator introduces Evan Seigerman from BMO Capital Markets, who asks two questions. The first question pertains to the expected uptake and sales assumptions for the pediatric launch of Opzelura, a treatment for atopic dermatitis in patients aged 2 to 11. Pablo Cagnoni responds optimistically, noting the significant unmet need in this age group and projecting that the pediatric indication could account for 10-15% of the total atopic dermatitis Opzelura business at its peak. Seigerman's second question is about the possibility of conducting a direct comparison trial between adalimumab and their product in treating hidradenitis suppurativa (HS). Herve Hoppenot answers that no decision has been made yet, suggesting that they will wait for the results of two ongoing HS studies before deciding on future trials.

The paragraph discusses challenges with the drug Humira in treating hidradenitis suppurativa (HS), noting that while initial studies showed high response rates, these have not been replicated in real-world settings. This has resulted in fast drug failure and dissatisfaction among physicians, making HS an important market for other companies to explore. There has been no decision on conducting a head-to-head study with Humira yet. An unidentified analyst asks about povo in the HS market and how upcoming data from competitors might affect its value proposition. Herve Hoppenot responds, highlighting the competitive efficacy and safety profile of povo based on Phase 2 data. The discussion concludes with a brief mention of Jakafi's growth being mainly driven by its use in polycythemia vera (PV).

In the paragraph, Pablo Cagnoni discusses the growth in the patient population for polycythemia vera (PV), highlighting that the fastest growth is driven by the adoption of earlier treatment. This approach, backed by data from the MAGIC study, helps reduce thrombosis incidence and prolong thrombosis-free survival. He also notes that changes in Medicare co-payments are positively impacting PV treatment adoption. Cagnoni anticipates that PV will become the largest indication over time, driven by new patients starting treatment earlier and longer treatment durations. Additionally, he mentions that the V617F mutation, responsible for 80% to 90% of PV cases in the U.S., will be a significant factor in future product development for Incyte.

This summary was generated with AI and may contain some inaccuracies.