Financial Performance - Revuforj net revenue in 2Q25 reached $28.6 million, representing a 43% quarter-over-quarter growth[6] - Niktimvo net revenue reported by Incyte in 2Q25 was $36.2 million, a substantial increase from $13.6 million in the first two months of Q1 launch[9] - Syndax reported $9.4 million in collaboration revenue from Niktimvo in 2Q25, achieving profitability in the first full quarter[9] - Syndax holds a strong financial position with $518 million in cash and equivalents as of June 30, 2025[28] Product Pipeline and Market Opportunity - Syndax estimates a $5B+ Total Addressable Market (TAM) for Revuforj and another $5B+ TAM for Niktimvo, indicating a $10B+ market opportunity across R/R and frontline indications[4, 30] - The initial Niktimvo indication represents a $2B U S market opportunity, with potential for label and geographic expansion leading to a $5B+ TAM[19, 20] - Approximately 33% of KMT2A patients are estimated to have proceeded to hematopoietic stem cell transplantation (HSCT) following Revuforj treatment[6, 12] Clinical Data and Development - Phase 2 Relapsed/Refractory (R/R) mNPM1 AML data for Revumenib showed a 26% (20/77) CR+CRh rate and a 48% (37/77) Overall Response Rate (ORR)[26] - Phase 1 R/R NUP98r AML data for Revumenib showed a 60% (3/5) ORR[26] - Over 80% of bone marrow transplant centers have ordered Niktimvo[18]

Core Insights - Incyte Corporation reported strong second-quarter 2025 results, with adjusted earnings of $1.57 per share, surpassing the Zacks Consensus Estimate of $1.39, and a significant improvement from an adjusted loss of $1.82 per share in the same quarter last year [2][10] Financial Performance - Total revenues for the second quarter reached $1.22 billion, reflecting a 16% year-over-year growth, driven by the performance of Jakafi and Opzelura, and exceeding the Zacks Consensus Estimate of $1.15 billion [3][10] - Jakafi sales amounted to $763.8 million, an 8% increase from the previous year, beating the Zacks Consensus Estimate of $744.1 million [4][10] - Opzelura cream generated $164.5 million in sales, a 35% year-over-year increase, surpassing the Zacks Consensus Estimate of $148.6 million [5][10] - Newly approved Zynyz generated $8.9 million in sales, significantly up from the previous year and exceeding the Zacks Consensus Estimate of $2.7 million [6] - Iclusig sales were $32.7 million, up 22% year over year, beating the Zacks Consensus Estimate of $29 million [6] - Pemazyre sales reached $22.2 million, reflecting a 9% increase and surpassing the Zacks Consensus Estimate of $20.2 million [6] - Minjuvi's revenues were $31.1 million, flat year over year, missing the Zacks Consensus Estimate of $34.3 million [7] - Axatilimab-csfr (Niktimvo) recorded $36.2 million in sales in its second quarter post-launch [8] Guidance and Future Outlook - The company raised its 2025 guidance for Jakafi revenues to a range of $3-$3.05 billion, up from the previous estimate of $2.95-$3 billion, while maintaining Opzelura's guidance at $630-$670 million [10][18] - Adjusted R&D expenses are now expected to be between $1.82-$1.84 billion, an increase from the prior guidance of $1.78-$1.81 billion [18] - Adjusted SG&A expenses are projected to be in the range of $1.16-$1.19 billion [18] Market Performance - Incyte's shares have increased by 1.6% year to date, outperforming the industry growth of 0.6% [9]

Core Insights - Incyte reported $1.22 billion in revenue for Q2 2025, a 16.5% year-over-year increase, with an EPS of $1.57 compared to -$1.82 a year ago, exceeding Zacks Consensus Estimates for both revenue and EPS [1] - The company’s revenue and EPS surprises were +5.56% and +12.95% respectively, indicating stronger performance than analysts anticipated [1] Revenue Breakdown - Product royalty revenues reached $151.12 million, surpassing the estimated $145.98 million, reflecting a 10.2% increase year-over-year [4] - Net product revenues for Iclusig were $32.73 million, exceeding the $28.99 million estimate, marking a 21.8% year-over-year growth [4] - Total net product revenues amounted to $1.06 billion, above the $985.29 million estimate, showing a 16.9% increase year-over-year [4] - Net product revenues for Pemazyre were $22.19 million, compared to the $20.24 million estimate, representing a 9.5% year-over-year change [4] - Net product revenues for Minjuvi/Monjuvi were $31.13 million, slightly below the $34.25 million estimate, with a minimal year-over-year change of 0.1% [4] - Net product revenues for Opzelura reached $164.5 million, exceeding the $148.56 million estimate, reflecting a significant 35.2% year-over-year increase [4] - Net product revenues for Jakafi were $763.79 million, surpassing the $744.1 million estimate, with an 8.2% year-over-year growth [4] - Net product revenues for Zynyz were $8.92 million, significantly above the $2.73 million estimate, indicating a remarkable 1270.4% year-over-year increase [4] - Royalty revenues for Olumiant were $33.48 million, slightly below the $33.57 million estimate, with a 5.6% year-over-year increase [4] - Royalty revenues for Tabrecta were $6.63 million, below the $6.88 million estimate, reflecting a 25.2% year-over-year increase [4] - Royalty revenues for Jakavi were $109.71 million, exceeding the $103.35 million estimate, with a 10.5% year-over-year change [4] - Net product revenues for Niktimvo were $36.15 million, significantly above the $20.33 million estimate [4] Stock Performance - Incyte's shares returned +3% over the past month, compared to the Zacks S&P 500 composite's +3.6% change, indicating a performance in line with the broader market [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the market in the near term [3]

2025 Second Quarter Financial and Corporate Update July 29, 2025 Second Quarter 2025 Earnings Call Agenda Introduction Greg Shertzer Investor Relations R&D Update Pablo Cagnoni Head of Research & Development Commercial & Financial Results Christiana Stamoulis Chief Financial Officer Opening Remarks Bill Meury Chief Executive Officer Available for Q&A Matteo Trotta EVP, Head of U.S. Dermatology Mohamed Issa EVP, Head of U.S. Oncology Steven Stein Chief Medical Officer Closing Remarks Bill Meury Chief Executi ...

Core Viewpoint - Incyte Corporation (INCY) is expected to exceed expectations in its second-quarter 2025 earnings report, with revenue estimates at $1.15 billion and earnings at $1.40 per share [1]. Factors Likely to Influence INCY's Q2 Results - Incyte's primary revenue source is from its lead drug, Jakafi (ruxolitinib), with strong sales anticipated across all approved indications, although competition may limit growth [2]. - The Zacks Consensus Estimate for Jakafi's sales in Q2 is $744 million, with higher royalties expected from Novartis due to increased Jakavi sales outside the U.S. [3][4]. Sales Performance of Other Drugs - Opzelura's sales are projected to reach $149 million, driven by new patient starts and strong uptake in the EU [8]. - Additional contributions to revenue are expected from other drugs like Minjuvi, Pemazyre, and Iclusig, with respective sales estimates of $34.25 million, $20.24 million, and $28.99 million [11]. Recent Developments - The FDA approved Monjuvi for a new cancer indication, which is likely to enhance its sales performance [10]. - Niktimvo, launched in Q1 2025, recorded $13.6 million in sales, and further updates on its launch activities are anticipated [12][13]. Earnings Surprise History - Incyte has a mixed earnings surprise history, with one earnings beat in the last four quarters and an average negative surprise of 82.37% [14]. Earnings Predictions - The Earnings ESP for Incyte is +1.43%, indicating a potential earnings beat, supported by a Zacks Rank of 3 [15][16].

Financial Performance - Revuforj generated $20.0 million in net revenue in 1Q25[3] - Niktimvo generated $13.6 million in net revenue in 1Q25 (reported by Incyte)[3] - The company held $602.1 million in cash and cash equivalents as of March 31, 2025[3] - Total revenue for 1Q25 was $20.0 million[24] - Net loss for 1Q25 was $84.8 million[24] Product Development and Milestones - Syndax initiated a pivotal frontline trial of revumenib with ven/aza in mNPM1 and KMT2Ar patients unfit for intensive chemo in 1Q25[3] - The company completed the submission of Revuforj sNDA for R/R mNPM1 AML in April 2025[3] - Syndax anticipates reporting Phase 1 data from a frontline trial evaluating revumenib with I C (7+3) in 4Q25[27] - Over 1,250 Niktimvo infusions have been ordered YTD[18] Market Access and Adoption - Two-thirds of accounts ordering Revuforj have ordered multiple times[10] - Approximately 95% of all Bone Marrow Transplants (BMTs) ordered are from top accounts[18]

Financial Performance - Total revenues reached $1.053 billion, a 20% year-over-year increase[10, 44] - Product revenues amounted to $922 million, reflecting a 26% year-over-year growth[10, 44] - Jakafi net sales were $709 million, up 24% year-over-year, driven by strong patient demand[23, 46] - Opzelura net sales reached $119 million, a 38% year-over-year increase, fueled by U.S prescription growth and European launches[34, 48] - Niktimvo achieved $14 million in net sales during its initial U.S launch[36] Product & Pipeline Development - Jakafi's FY25 guidance raised to $2.95 - $3.0 billion[26] - Opzelura's FY25 guidance is $630 - $670 million[34] - Povorcitinib demonstrated positive Phase 2 results in CSU, with a planned discussion with the FDA to finalize Phase 3 design[15, 68] - The company anticipates having more than 10 high impact launches by 2030[5, 63] Financial Outlook - The company has $2.4 billion in cash[11] - GAAP Cost of product revenues is unchanged at 8.5 – 9% of net product revenues[60] - GAAP Research and development expenses is unchanged at $1.930 - $1.960 million[60]

Financial Data and Key Metrics Changes - For Q4 2024, Syndax Pharmaceuticals reported $7.7 million in net revenue from Revuforj, marking the company's first quarter with product revenue [10][46] - Operating expenses for Q4 were $104 million, which included $65.5 million in research and development expenses and $37.7 million in selling, general, and administrative expenses [46] - The company maintained a strong financial position with $692.4 million in cash, equivalents, and investments at year-end [47] Business Line Data and Key Metrics Changes - Revuforj, the first-in-class menin inhibitor, launched in November 2024, has shown strong early demand with $7.7 million in net revenue from the first five weeks of sales [10][11] - Niktimvo, launched in January 2025 for chronic graft versus host disease, is expected to capture a significant portion of the $1.5 billion to $2 billion market for third-line or later chronic GVHD treatment in the US [32] Market Data and Key Metrics Changes - Approximately 33% of Tier 1 and Tier 2 accounts have ordered Revuforj, indicating strong early penetration in key treatment centers [21][22] - The company is seeing rapid inclusion of Revuforj in payer coverage, with 56% of commercially covered lives and 53% of all managed care lives having formal coverage policies in place [25] Company Strategy and Development Direction - The company aims to expand Revuforj's indication to include mutant NPM1 AML by filing a supplemental new drug application in the upcoming quarter [12] - Syndax is focused on building a robust pipeline in oncology, with plans to extend its products into earlier line indications and develop additional targeted therapies [99][100] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position for long-term growth, highlighting the strong market opportunities with Revuforj and Niktimvo [54] - The management team emphasized the importance of building a habit among physicians for prescribing Revuforj, which is expected to become the standard of care for KMT2A translocations [24][60] Other Important Information - The company received $350 million upfront from Royalty Pharma in exchange for a capped royalty on US net sales of Niktimvo, indicating the product's multi-billion-dollar potential [15] - The company expects R&D expenses for Q1 2025 to be between $65 million and $70 million, with total R&D plus SG&A expenses projected to be between $105 million and $110 million [48] Q&A Session Summary Question: Inventory levels and repeat prescribers for Revuforj - Management indicated that inventory levels are expected to remain stable at about two to three weeks, with revenue growth potentially increasing absolute inventory levels [62] - Approximately one-third of Tier 1 and Tier 2 accounts have ordered Revuforj, with most accounts having prescribed it more than once, indicating positive early adoption [65] Question: Activation of Tier 1/2 accounts and comparison to historic AML launches - Management expects continued activation of Tier 1 and Tier 2 accounts over the next 10 months, with a focus on the top 200 treatment centers [73] - The unique setup of Revuforj, including diagnostic testing for KMT2A patients, is expected to drive its adoption compared to other targeted therapies [78] Question: Off-label use and Expanded Access Program (EAP) - Anecdotal evidence suggests some off-label use of Revuforj, particularly in combination treatments, but specific numbers are not yet available [86] - The EAP remains lightly used, with no additional patients expected to transition from it at this time [87] Question: Future company vision and pipeline expansion - The company aims to build a larger pipeline in oncology and expects to have multiple commercial products by 2030, focusing on targeted therapies [100][101] Question: Safety feedback and physician experience with Revuforj - Feedback on Revuforj's safety profile has been positive, with comprehensive support provided to physicians through clinical nurse educators [110] Question: Gross to net adjustments and patient assistance programs - The gross to net adjustments for Revuforj are expected to remain tight due to the limited distribution channel, with a patient assistance program available for uninsured or underinsured patients [118][120] Question: Transplant dynamics and patient treatment pathways - Physicians are interested in getting patients to transplant, particularly for KMT2A, with expectations that many patients will return to maintenance therapy post-transplant [122]