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INCY

IncyteB
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-09-03
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Earnings documents stored for INCY.

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Investor releaseQuarter not tagged2026-09-03

Why Is Acadia (ACAD) Up 0.5% Since Last Earnings Report?

Zacks
It has been about a month since the last earnings report for Acadia Pharmaceuticals (ACAD). Shares have added about 0.5% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Acadia due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers. Acadia reported second-quarter 2026 earnings of 18 cents per share, which surpassed the Zacks Consensus Estimate of 6 cents. The company had reported earnings of 16 cents per share in the year-ago quarter. Revenues of $308 million beat the Zacks Consensus Estimate of $294 million, reflecting a 16% year-over-year increase. Growth was supported by higher marketed product sales. Acadia’s revenues comprise net product sales from its two marketed drugs, Daybue and Nuplazid. Reported revenues increased from $264.6 million in the second quarter of 2025 to $308 million in the reported quarter. The company’s quarterly performance benefited from continued demand for both products. Daybue growth was supported by the uptake of the recently launched Daybue STIX formulation, while Nuplazid benefited from volume growth and increased new-patient prescriptions. Reported net product sales of Nuplazid were $183.2 million in the second quarter of 2026, up 9% from $168.5 million in the year-ago period. The drug is approved in the United States for treating hallucinations and delusions associated with Parkinson’s disease psychosis. Nuplazid sales beat the Zacks Consensus Estimate of $181.5 million. Management stated that Nuplazid’s growth was primarily volume-driven. New-patient prescriptions increased 20% year over year and reached their highest quarterly level since the first quarter of 2018. Acadia also continued to expand engagement with priority health care providers through its enlarged field force. Daybue reported net product sales of $124.8 million, up 30% from $96.1 million in the second quarter of 2025. Daybue is approved in the United States for treating Rett syndrome in adult and pediatric patients two years of age and older. The reported figure beat the Zacks Consensus Estimate of $111.3 million. Growth was driven largely by volume and strong uptake of Daybue STIX. Appr…Read full document

It has been about a month since the last earnings report for Acadia Pharmaceuticals (ACAD). Shares have added about 0.5% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Acadia due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers. Acadia reported second-quarter 2026 earnings of 18 cents per share, which surpassed the Zacks Consensus Estimate of 6 cents. The company had reported earnings of 16 cents per share in the year-ago quarter. Revenues of $308 million beat the Zacks Consensus Estimate of $294 million, reflecting a 16% year-over-year increase. Growth was supported by higher marketed product sales. Acadia’s revenues comprise net product sales from its two marketed drugs, Daybue and Nuplazid. Reported revenues increased from $264.6 million in the second quarter of 2025 to $308 million in the reported quarter. The company’s quarterly performance benefited from continued demand for both products. Daybue growth was supported by the uptake of the recently launched Daybue STIX formulation, while Nuplazid benefited from volume growth and increased new-patient prescriptions. Reported net product sales of Nuplazid were $183.2 million in the second quarter of 2026, up 9% from $168.5 million in the year-ago period. The drug is approved in the United States for treating hallucinations and delusions associated with Parkinson’s disease psychosis. Nuplazid sales beat the Zacks Consensus Estimate of $181.5 million. Management stated that Nuplazid’s growth was primarily volume-driven. New-patient prescriptions increased 20% year over year and reached their highest quarterly level since the first quarter of 2018. Acadia also continued to expand engagement with priority health care providers through its enlarged field force. Daybue reported net product sales of $124.8 million, up 30% from $96.1 million in the second quarter of 2025. Daybue is approved in the United States for treating Rett syndrome in adult and pediatric patients two years of age and older. The reported figure beat the Zacks Consensus Estimate of $111.3 million. Growth was driven largely by volume and strong uptake of Daybue STIX. Approximately 40% of U.S. Daybue patients were receiving STIX by the end of the quarter. The company also recorded a quarterly high in the number of patients returning to Daybue treatment. Acadia stated that around 60% of total referrals during the quarter came from treatment-naive patients, while 40% represented returning patients. For STIX specifically, 55% of patients switched from the oral solution, while the remaining 45% were new or returning patients. Research and development (R&D) expenses were $82 million in the second quarter of 2026, up 5% from $78 million in the year-ago period. Selling, general and administrative (SG&A) expenses increased 20% year over year to $160 million from $134 million. The increase reflected investments in expanding the Nuplazid and Daybue field forces and higher marketing spending to support both brands. Acadia had cash, cash equivalents and investment securities worth $956 million as of June 30, 2026, compared with $851 million as of March 31, 2026. Following the strong quarterly performance, Acadia raised its total revenue guidance for 2026 to a range of $1.24 billion to $1.30 billion. The previous guidance range was $1.22 billion to $1.28 billion. The company increased its Daybue global net product sales forecast to $480-$510 million from the prior range of $460-$490 million. The revised outlook reflects strong U.S. demand, uptake of STIX and expected contributions from international markets. Nuplazid net product sales guidance was maintained at $760-$790 million. Management expects the expanded field force to have a greater impact on Nuplazid’s performance later in the year as sales representatives deepen engagement with targeted physicians. Acadia now expects R&D expense in the range of $355-$380 million, down from the previous range of $385-$410 million. SG&A expenses continue to be expected between $660 million and $700 million. In the past month, investors have witnessed a upward trend in estimates review. The consensus estimate has shifted 59.62% due to these changes. At this time, Acadia has a nice Growth Score of B, however its Momentum Score is doing a bit better with an A. However, the stock was allocated a grade of C on the value side, putting it in the middle 20% for this investment strategy. Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Notably, Acadia has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Acadia belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Incyte (INCY), has gained 7.5% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. Incyte reported revenues of $1.67 billion in the last reported quarter, representing a year-over-year change of +37.7%. EPS of $3.09 for the same period compares with $1.57 a year ago. For the current quarter, Incyte is expected to post a loss of $3.31 per share, indicating a change of -246.5% from the year-ago quarter. The Zacks Consensus Estimate remained unchanged over the last 30 days. Incyte has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of A. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report ACADIA Pharmaceuticals Inc. (ACAD) : Free Stock Analysis Report Incyte Corporation (INCY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-28

Why Is uniQure (QURE) Up 17.5% Since Last Earnings Report?

Zacks
A month has gone by since the last earnings report for uniQure (QURE). Shares have added about 17.5% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is uniQure due for a pullback? Well, first let's take a quick look at its most recent earnings report in order to get a better handle on the recent catalysts for uniQure N.V. before we dive into how investors and analysts have reacted as of late. QURE Q2 Earnings Miss Estimates on Higher Costs, Revenues Rise Y/Y uniQure incurred a second-quarter 2026 loss of $1.22 per share, wider than the Zacks Consensus Estimate of a loss of 81 cents. The loss widened 76.8% year over year, primarily due to higher non-operating and other expenses. Revenues rose 11% year over year to $5.8 million, driven primarily by higher license revenues. However, the metric missed the Zacks Consensus Estimate of $7 million. The company did not record any product sales during the quarter. Its revenue base continues to depend substantially on licensing arrangements, including economics associated with Hemgenix under its collaboration with CSL Behring. QURE’s Quarter in Detail Research and development (R&D) expenses declined 4% year over year to $34 million, primarily due to a $3.2 million reduction in other R&D expenses, partially offset by a $1.8 million increase in direct R&D spending. Selling, general and administrative expenses increased 28.6% year over year to $17.4 million. The increase primarily reflected higher employee-related costs to support the potential commercial launch of AMT-130, along with increased intellectual property and information technology costs, partially offset by lower professional fees. Other expenses surged 264.3% to $8 million, mainly due to a $6 million rise in costs associated with supplying Hemgenix to CSL Behring. uniQure ended the quarter with cash, cash equivalents and investments totaling $810.3 million compared with $586.6 million as of March 31, 2026. Management expects its current cash resources to fund operations into 2030. QURE’s Key Pipeline Updates uniQure continues to make significant regulatory progress with AMT-130, its investigational gene therapy for Huntington's disease. Following a Type B meeting in June 2026, the FDA agreed that a biologics license application (BLA) seeking…Read full document

A month has gone by since the last earnings report for uniQure (QURE). Shares have added about 17.5% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is uniQure due for a pullback? Well, first let's take a quick look at its most recent earnings report in order to get a better handle on the recent catalysts for uniQure N.V. before we dive into how investors and analysts have reacted as of late. QURE Q2 Earnings Miss Estimates on Higher Costs, Revenues Rise Y/Y uniQure incurred a second-quarter 2026 loss of $1.22 per share, wider than the Zacks Consensus Estimate of a loss of 81 cents. The loss widened 76.8% year over year, primarily due to higher non-operating and other expenses. Revenues rose 11% year over year to $5.8 million, driven primarily by higher license revenues. However, the metric missed the Zacks Consensus Estimate of $7 million. The company did not record any product sales during the quarter. Its revenue base continues to depend substantially on licensing arrangements, including economics associated with Hemgenix under its collaboration with CSL Behring. QURE’s Quarter in Detail Research and development (R&D) expenses declined 4% year over year to $34 million, primarily due to a $3.2 million reduction in other R&D expenses, partially offset by a $1.8 million increase in direct R&D spending. Selling, general and administrative expenses increased 28.6% year over year to $17.4 million. The increase primarily reflected higher employee-related costs to support the potential commercial launch of AMT-130, along with increased intellectual property and information technology costs, partially offset by lower professional fees. Other expenses surged 264.3% to $8 million, mainly due to a $6 million rise in costs associated with supplying Hemgenix to CSL Behring. uniQure ended the quarter with cash, cash equivalents and investments totaling $810.3 million compared with $586.6 million as of March 31, 2026. Management expects its current cash resources to fund operations into 2030. QURE’s Key Pipeline Updates uniQure continues to make significant regulatory progress with AMT-130, its investigational gene therapy for Huntington's disease. Following a Type B meeting in June 2026, the FDA agreed that a biologics license application (BLA) seeking accelerated approval based on the existing three-year phase I/II clinical data is reasonable, while requesting alignment on the confirmatory study design before submission. The company remains on track to submit the BLA in the third quarter of 2026 and plans to initiate the confirmatory study thereafter. In September 2026, uniQure expects to present updated data from its ongoing phase I/II studies on AMT-130 for the treatment of Huntington's disease, including four-year follow-up results from the first two patient cohorts. The company is advancing regulatory plans in the United Kingdom, with a regulatory submission scheduled for the third quarter of 2026. Apart from AMT-130, QURE’s pipeline comprises a few other candidates that are currently in development.  The company is evaluating AMT-260 for the treatment of refractory mesial temporal lobe epilepsy in the phase I/IIa study. The other candidate in the pipeline is AMT-191 for the treatment of Fabry disease. In June, the company announced encouraging preliminary six-month data from its phase I/IIa study, which demonstrated meaningful reductions in disabling seizures in half of the patients enrolled in the first low-dose cohort. uniQure expects to complete enrollment in the second dose cohort in the third quarter of 2026, with updated clinical data anticipated in the first half of 2027. In the past month, investors have witnessed a upward trend in estimates revision. The consensus estimate has shifted 6.37% due to these changes. At this time, uniQure has a poor Growth Score of F, a grade with the same score on the momentum front. Following the exact same course, the stock has a grade of F on the value side, putting it in the lowest quintile for this investment strategy. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Notably, uniQure has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. uniQure belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Incyte (INCY), has gained 3.9% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. Incyte reported revenues of $1.67 billion in the last reported quarter, representing a year-over-year change of +37.7%. EPS of $3.09 for the same period compares with $1.57 a year ago. Incyte is expected to post a loss of $3.31 per share for the current quarter, representing a year-over-year change of -246.5%. Over the last 30 days, the Zacks Consensus Estimate has changed -90.4%. Incyte has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of B. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report uniQure N.V. (QURE) : Free Stock Analysis Report Incyte Corporation (INCY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-27

Incyte (INCY) Up 0.8% Since Last Earnings Report: Can It Continue?

Zacks
It has been about a month since the last earnings report for Incyte (INCY). Shares have added about 0.8% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Incyte due for a pullback? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent catalysts for Incyte Corporation before we dive into how investors and analysts have reacted as of late. INCY Q2 Earnings & Revenues Beat on Higher Sales, '26 View Raised Incyte Corporation reported second-quarter 2026 adjusted earnings of $3.09 per share, which beat the Zacks Consensus Estimate of $2.00, primarily due to higher product sales. The company had reported adjusted earnings of $1.57 per share in the year-ago quarter. Total revenues in the second quarter were $1.67 billion, which grew 38% year over year, driven primarily by the sustained performance of its lead drug, Jakafi (ruxolitinib), and increased sales of Opzelura (ruxolitinib) cream on strong launch and demand. The top line beat the Zacks Consensus Estimate of $1.46 billion. All percentages mentioned below are on a reported basis. INCY's Q2 Results in Detail Revenues from the sale of Jakafi, a first-in-class JAK1/JAK2 inhibitor approved for polycythemia vera, myelofibrosis and refractory acute graft-versus-host disease (GVHD), amounted to $816.7 million, up 7% from the year-ago quarter, owing to a 9% increase in paid demand and growth across all indications. Jakafi's sales beat the Zacks Consensus Estimate of $798 million. Opzelura (ruxolitinib) cream, approved for atopic dermatitis and vitiligo, generated $449.7 million in sales, which rose 173% year over year, beating the Zacks Consensus Estimate of $277.8 million. The massive uptick was driven by a one-time, non-cash benefit of $246 million associated with the reversal of previously established accrual balances through March 31, 2026, for Opzelura, as well as by increased patient demand in both approved indications. The newly approved medicine Zynyz (retifanlimab-dlwr) generated sales of $49.9 million, which significantly increased from the year-ago quarter and beat the Zacks Consensus Estimate of $43.8 million. The company obtained accelerated approval for Zynyz to treat metastatic or recurrent locally advanced Merkel cell carcinoma. Net product revenues of I…Read full document

It has been about a month since the last earnings report for Incyte (INCY). Shares have added about 0.8% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Incyte due for a pullback? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent catalysts for Incyte Corporation before we dive into how investors and analysts have reacted as of late. INCY Q2 Earnings & Revenues Beat on Higher Sales, '26 View Raised Incyte Corporation reported second-quarter 2026 adjusted earnings of $3.09 per share, which beat the Zacks Consensus Estimate of $2.00, primarily due to higher product sales. The company had reported adjusted earnings of $1.57 per share in the year-ago quarter. Total revenues in the second quarter were $1.67 billion, which grew 38% year over year, driven primarily by the sustained performance of its lead drug, Jakafi (ruxolitinib), and increased sales of Opzelura (ruxolitinib) cream on strong launch and demand. The top line beat the Zacks Consensus Estimate of $1.46 billion. All percentages mentioned below are on a reported basis. INCY's Q2 Results in Detail Revenues from the sale of Jakafi, a first-in-class JAK1/JAK2 inhibitor approved for polycythemia vera, myelofibrosis and refractory acute graft-versus-host disease (GVHD), amounted to $816.7 million, up 7% from the year-ago quarter, owing to a 9% increase in paid demand and growth across all indications. Jakafi's sales beat the Zacks Consensus Estimate of $798 million. Opzelura (ruxolitinib) cream, approved for atopic dermatitis and vitiligo, generated $449.7 million in sales, which rose 173% year over year, beating the Zacks Consensus Estimate of $277.8 million. The massive uptick was driven by a one-time, non-cash benefit of $246 million associated with the reversal of previously established accrual balances through March 31, 2026, for Opzelura, as well as by increased patient demand in both approved indications. The newly approved medicine Zynyz (retifanlimab-dlwr) generated sales of $49.9 million, which significantly increased from the year-ago quarter and beat the Zacks Consensus Estimate of $43.8 million. The company obtained accelerated approval for Zynyz to treat metastatic or recurrent locally advanced Merkel cell carcinoma. Net product revenues of Iclusig were $34.4 million, up 5% year over year. The figure missed the Zacks Consensus Estimate of $35.5 million. Pemazyre generated $23.4 million in sales, reflecting a year-over-year increase of 6%. The figure surpassed the Zacks Consensus Estimate of $22.4 million. Minjuvi's revenues totaled $53.7 million, up 72% year over year. The figure beat the Zacks Consensus Estimate of $50.6 million. Incyte gained exclusive global rights for tafasitamab from MorphoSys AG, which is marketed as Monjuvi in the United States and as Minjuvi in the ex-U.S. markets in 2024. Incyte and partner Syndax Pharmaceuticals obtained FDA approval for axatilimab-csfr, an anti-CSF-1R antibody, for the treatment of GVHD after the failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. The candidate was approved under the brand name Niktimvo. The drug is Incyte’s second approved treatment for chronic GVHD (third-line) and was launched in the United States during the first quarter of 2025. The drug recorded $60.3 million in sales in the second quarter of 2026, up 67% on a year-over-year basis, driven by strong uptake, but missed the Zacks Consensus Estimate of $63.8 million. Shares of Incyte have rallied 20.3% year to date compared with the industry’s 2% growth. Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi in ex-U.S. markets. Jakavi royalty revenues from Novartis for commercialization in ex-U.S. markets rose 13% to $124.2 million. Jakavi royalties beat the Zacks Consensus Estimate of $117 million. Incyte also receives royalties from the sales of Tabrecta (capmatinib) for the treatment of adult patients with metastatic non-small-cell lung cancer. Its partner, Novartis, has exclusive worldwide development and commercialization rights for Tabrecta. Royalty revenues from the drug’s sales amounted to $6.7 million, up 1% year over year. The reported figure missed the Zacks Consensus Estimate of $7.1 million. Olumiant’s (baricitinib) product royalty revenues from Eli Lilly totaled $38.5 million, up 15% year over year. The figure beat the Zacks Consensus Estimate of $36.9 million. Incyte has a collaboration agreement with Eli Lilly for Olumiant. The drug is a once-daily oral JAK inhibitor discovered by Incyte and licensed to LLY. It is approved for several types of autoimmune diseases. Adjusted research and development (R&D) expenses totaled $478.8 million, up 5% year over year. This increase was primarily due to continued investment in late-stage development assets. Adjusted selling, general and administrative (SG&A) expenses were $323.6 million, up 6% from the prior-year quarter’s number, primarily due to increased consumer marketing and pre-launch activities. INCY’s cash, cash equivalents and marketable securities amounted to $4.5 billion as of June 30, 2026, compared with $4 billion recorded as of March 31, 2026. INCY Raises 2026 Guidance While Incyte continues to expect Jakafi revenues in the range of $3.22-$3.27 billion in 2026, it now expects Opzelura net product revenues to be in the range of $1.05-$1.1 billion, up from the previously guided range of $750-$790 million. Net product revenues for 2026 are now expected to be in the range of $5.13-$5.26 billion, up from the previously guided range of $4.77-$4.94 billion. Total adjusted R&D expenses and SG&A expenses for 2026 are now expected in the range of $4.625-$4.695 billion compared with the previous guidance of $3.205-$3.375 billion. In the past month, investors have witnessed a downward trend in estimates revision. The consensus estimate has shifted -298.32% due to these changes. At this time, Incyte has a strong Growth Score of A, though it is lagging a lot on the Momentum Score front with an F. However, the stock was allocated a score of B on the value side, putting it in the second quintile for value investors. Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Incyte has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Incyte Corporation (INCY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-06

Mirum's Q2 Earnings Lag Estimates, Revenues Beat, 2026 View Raised

Zacks
Mirum Pharmaceuticals MIRM reported a loss of 80 cents per share (excluding certain one-time expenses) for the second quarter of 2026, wider than the Zacks Consensus Estimate of a loss of 77 cents. The company had reported a loss of 12 cents per share in the year-ago quarter. Revenues in the second quarter totaled $176.2 million, up 37.9% year over year. The figure also beat the Zacks Consensus Estimate of $165 million. The top line was driven by strong growth of its marketed products, Livmarli (maralixibat) and bile acid medicines, Cholbam and Ctexli (chenodiol). Livmarli is approved for treating cholestatic pruritus in patients with Alagille syndrome worldwide. The drug is also approved for treating certain patients with progressive familial intrahepatic cholestasis in the United States and Europe. The FDA has also approved a new tablet formulation of Livmarli for the treatment of cholestatic pruritus in patients with Alagille syndrome and progressive familial intrahepatic cholestasis. The oral tablet was launched in the United States in June 2025, which is likely to offer convenience for older patients. Mirum acquired Travere Therapeutics’ bile acid products in August 2023, which added the latter’s Cholbam capsules and Ctexli tablets to its portfolio of commercialized drugs. Shares of Mirum have rallied 34% so far this year compared with the industry’s rise of 3.4%. Image Source: Zacks Investment Research Livmarli’s net product sales were $128.7 million in the second quarter, reflecting an increase of 46% year over year. Livmarli sales in the United States were $92 million, reflecting strong demand across all indications. In ex-U.S. markets, Livmarli sales were $37 million. Net product sales of bile acid products, comprising Cholbam and Ctexli tablets, were $47.5 million in the quarter, reflecting an increase of 20% year over year. The company did not record any license and other revenues in the reported quarter. Research and development expenses increased almost 96.3% year over year to $90.5 million. Selling, general and administrative expenses totaled $81.5 million, up almost 28.8% from the year-ago quarter’s level. As of June 30, 2026, Mirum had cash, cash equivalents and investments worth $561.3 million compared with $420.6 million as of March 31, 2026. In view of the strong performance of its marketed products, Mirum raised its revenue guidance for 2…Read full document

Mirum Pharmaceuticals MIRM reported a loss of 80 cents per share (excluding certain one-time expenses) for the second quarter of 2026, wider than the Zacks Consensus Estimate of a loss of 77 cents. The company had reported a loss of 12 cents per share in the year-ago quarter. Revenues in the second quarter totaled $176.2 million, up 37.9% year over year. The figure also beat the Zacks Consensus Estimate of $165 million. The top line was driven by strong growth of its marketed products, Livmarli (maralixibat) and bile acid medicines, Cholbam and Ctexli (chenodiol). Livmarli is approved for treating cholestatic pruritus in patients with Alagille syndrome worldwide. The drug is also approved for treating certain patients with progressive familial intrahepatic cholestasis in the United States and Europe. The FDA has also approved a new tablet formulation of Livmarli for the treatment of cholestatic pruritus in patients with Alagille syndrome and progressive familial intrahepatic cholestasis. The oral tablet was launched in the United States in June 2025, which is likely to offer convenience for older patients. Mirum acquired Travere Therapeutics’ bile acid products in August 2023, which added the latter’s Cholbam capsules and Ctexli tablets to its portfolio of commercialized drugs. Shares of Mirum have rallied 34% so far this year compared with the industry’s rise of 3.4%. Image Source: Zacks Investment Research Livmarli’s net product sales were $128.7 million in the second quarter, reflecting an increase of 46% year over year. Livmarli sales in the United States were $92 million, reflecting strong demand across all indications. In ex-U.S. markets, Livmarli sales were $37 million. Net product sales of bile acid products, comprising Cholbam and Ctexli tablets, were $47.5 million in the quarter, reflecting an increase of 20% year over year. The company did not record any license and other revenues in the reported quarter. Research and development expenses increased almost 96.3% year over year to $90.5 million. Selling, general and administrative expenses totaled $81.5 million, up almost 28.8% from the year-ago quarter’s level. As of June 30, 2026, Mirum had cash, cash equivalents and investments worth $561.3 million compared with $420.6 million as of March 31, 2026. In view of the strong performance of its marketed products, Mirum raised its revenue guidance for 2026. The company now expects worldwide net product sales of $680-$700 million in 2026 compared with the previous expectation of $660-$680 million. In March 2026, Mirum completed enrollment in the phase III EXPAND study evaluating Livmarli for treating additional rare cholestatic conditions. Top-line data from the same is expected in the fourth quarter of 2026. Mirum’s lead pipeline candidate, volixibat, is currently being evaluated in two phase IIb studies for treating patients with primary biliary cholangitis or PBC (the VANTAGE study) and primary sclerosing cholangitis or PSC (the VISTAS study). The company recently had a pre-new drug application (NDA) meeting with the FDA for volixibat in cholestatic pruritus due to PSC. Mirum is now planning additional discussions with the FDA before a potential NDA submission for volixibat in PSC in the first half of 2027. The FDA has granted Breakthrough Therapy designation and Orphan Drug designation to volixibat for the treatment of cholestatic pruritus due to PSC. Meanwhile, the company expects to report top-line data from the VANTAGE study in the first quarter of 2027. Mirum recently completed the acquisition of privately held biotech Bluejay Therapeutics. Through this deal, it added brelovitug — a fully human monoclonal antibody being developed to treat chronic hepatitis delta virus (“HDV”) — to its pipeline. Top-line data from the phase III AZURE-1 and AZURE-4 studies evaluating brelovitug in HDV are expected in the third and fourth quarters of 2026, respectively. Mirum recently in-licensed exclusive worldwide rights to zilurgisertib, a once-daily oral ALK2 inhibitor from Incyte INCY. The candidate is being developed for treating fibrodysplasia ossificans progressiva (FOP). In June 2026, Mirum and Incyte announced positive phase II results from Cohort 1 of the PROGRESS study evaluating zilurgisertib in adolescents and adults aged 12 years and older with FOP. Cohort 1 results showed meaningful reductions in total heterotopic ossification (HO) lesion volume, new HO lesions and flare activity in adolescents and adults with FOP. These results were shared in a late-breaking presentation at ENDO 2026, the Endocrine Society’s annual meeting. The FDA has accepted the new drug application seeking approval for zilurgisertib in FOP under Priority Review with a target action date of Sept. 26, 2026. Upon potential approval, Mirum expects to launch zilurgisertib in the fourth quarter of 2026. Also, a marketing application for zilurgisertib in FOP has been submitted in Europe. Mirum Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Mirum Pharmaceuticals, Inc. Quote Mirum currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Repligen RGEN and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 3.4% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 158.4% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Mirum Pharmaceuticals, Inc. (MIRM) : Free Stock Analysis Report Incyte Corporation (INCY) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-01

Incyte (INCY) Stock Trades Reasonable On Earnings While Returns Look Strong

Simply Wall St.
Find winning stocks in any market cycle. Join 7 million investors using Simply Wall St's investing ideas for FREE. Incyte stock has delivered a strong run over the last three years, yet the broader valuation checks suggest it may no longer stand out as a clear bargain at current levels. Incyte has returned 87.8% over the past three years, which puts fresh focus on whether recent gains already reflect much of the good news. Recent approvals for Opzelura in atopic dermatitis and new partnership activity can support confidence in future revenue, while execution risk around expanding treatments and partnerships may still affect how much of that potential is ultimately reflected in cash flows. On Simply Wall St's broader valuation framework, Incyte scores 2 out of 6, which leans more toward expensive than cheap on these checks. The issue now is whether Incyte's strong share price performance has moved the stock closer to being fully valued, or if there is still room for further upside based on fundamentals. Incyte delivered 58.1% returns over the last year. See how this stacks up to the rest of the Biotechs industry. The P/E ratio is a useful way to look at Incyte because it ties the share price directly to the earnings that support it. On this measure, Incyte trades at about 15.0x earnings. That compares with an industry average P/E of roughly 17.1x for biotechs and a peer group average around 23.2x. The stock therefore sits below both the broader biotech group and its closer peers on this simple earnings yardstick. The fair P/E multiple from the broader framework is about 14.8x, which is very close to where Incyte is currently priced. Despite the recent Opzelura approval in the EU and stronger recent earnings headlines, the market multiple still sits in line with what this framework suggests for the business when growth, margins, size and risk are considered together. In other words, the latest news and share price move have not pushed the P/E into an obvious bargain or bubble zone on these checks. Overall, Incyte appears roughly fairly valued on its P/E ratio based on these benchmarks. See what the numbers say about this price — find out in our valuation breakdown. Simply Wall St Narratives aim to connect Incyte's current valuation puzzle with clear scenarios by spelling out what assumptions on future growth, margins and earnings would need to hold for the sto…Read full document

Find winning stocks in any market cycle. Join 7 million investors using Simply Wall St's investing ideas for FREE. Incyte stock has delivered a strong run over the last three years, yet the broader valuation checks suggest it may no longer stand out as a clear bargain at current levels. Incyte has returned 87.8% over the past three years, which puts fresh focus on whether recent gains already reflect much of the good news. Recent approvals for Opzelura in atopic dermatitis and new partnership activity can support confidence in future revenue, while execution risk around expanding treatments and partnerships may still affect how much of that potential is ultimately reflected in cash flows. On Simply Wall St's broader valuation framework, Incyte scores 2 out of 6, which leans more toward expensive than cheap on these checks. The issue now is whether Incyte's strong share price performance has moved the stock closer to being fully valued, or if there is still room for further upside based on fundamentals. Incyte delivered 58.1% returns over the last year. See how this stacks up to the rest of the Biotechs industry. The P/E ratio is a useful way to look at Incyte because it ties the share price directly to the earnings that support it. On this measure, Incyte trades at about 15.0x earnings. That compares with an industry average P/E of roughly 17.1x for biotechs and a peer group average around 23.2x. The stock therefore sits below both the broader biotech group and its closer peers on this simple earnings yardstick. The fair P/E multiple from the broader framework is about 14.8x, which is very close to where Incyte is currently priced. Despite the recent Opzelura approval in the EU and stronger recent earnings headlines, the market multiple still sits in line with what this framework suggests for the business when growth, margins, size and risk are considered together. In other words, the latest news and share price move have not pushed the P/E into an obvious bargain or bubble zone on these checks. Overall, Incyte appears roughly fairly valued on its P/E ratio based on these benchmarks. See what the numbers say about this price — find out in our valuation breakdown. Simply Wall St Narratives aim to connect Incyte's current valuation puzzle with clear scenarios by spelling out what assumptions on future growth, margins and earnings would need to hold for the stock to be worth materially more or less than today. Each narrative links its number to a concrete view of how Incyte's growth, profitability and risk profile could evolve, which you can revisit as new information becomes available on the Community page. Community views on Incyte sit far apart, with one side focused on the hematology pipeline upside and the other on Jakafi dependence and execution risk. Bull case: 15% undervalued Read the full Bull Case to see why Incyte could be undervalued Bear case: roughly fairly valued Read the full Bear Case to see why Incyte could be overvalued Do you think there's more to the story for Incyte? Head over to our Community to see what others are saying! For now, Incyte looks roughly in line with what its P/E suggests rather than clearly undervalued or overvalued. The stock no longer screens as an obvious bargain on the broader valuation checks, even if some investors still see upside in the pipeline and partnerships. The real swing factor from here is whether Incyte can turn its current portfolio and new treatments into durable earnings that justify any further re rating of the multiple, despite concerns around concentration in Jakafi. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include INCY. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Investor releaseQuarter not tagged2026-07-28

INCY Q2 Earnings & Revenues Beat on Higher Sales, '26 View Raised

Zacks
Incyte Corporation INCY reported second-quarter 2026 adjusted earnings of $3.09 per share, which beat the Zacks Consensus Estimate of $2.00, primarily due to higher product sales. The company had reported adjusted earnings of $1.57 per share in the year-ago quarter. Total revenues in the second quarter were $1.67 billion, which grew 38% year over year, driven primarily by the sustained performance of its lead drug, Jakafi (ruxolitinib), and increased sales of Opzelura (ruxolitinib) cream on strong launch and demand. The top line beat the Zacks Consensus Estimate of $1.46 billion. All percentages mentioned below are on a reported basis. Revenues from the sale of Jakafi, a first-in-class JAK1/JAK2 inhibitor approved for polycythemia vera, myelofibrosis and refractory acute graft-versus-host disease (GVHD), came in at $816.7 million, up 7% from the year-ago quarter, owing to a 9% increase in paid demand and growth across all indications. Jakafi's sales beat the Zacks Consensus Estimate of $798 million. Opzelura (ruxolitinib) cream, approved for atopic dermatitis and vitiligo, generated $449.7 million in sales, which rose 173% year over year, beating the Zacks Consensus Estimate of $277.8 million. The massive uptick was driven by a one-time, non-cash benefit of $246 million associated with the reversal of previously established accrual balances through March 31, 2026, for Opzelura, as well as by increased patient demand in both approved indications. The newly approved medicine Zynyz (retifanlimab-dlwr) generated sales of $49.9 million, which significantly increased from the year-ago quarter and beat the Zacks Consensus Estimate of $43.8 million. The company obtained accelerated approval for Zynyz to treat metastatic or recurrent locally advanced Merkel cell carcinoma. Net product revenues of Iclusig were $34.4 million, up 5% year over year. The figure missed the Zacks Consensus Estimate of $35.5 million. Pemazyre generated $23.4 million in sales, reflecting a year-over-year increase of 6%. The figure surpassed the Zacks Consensus Estimate of $22.4 million. Minjuvi's revenues totaled $53.7 million, up 72% year over year. The figure beat the Zacks Consensus Estimate of $50.6 million. Incyte gained exclusive global rights for tafasitamab from MorphoSys AG, which is marketed as Monjuvi in the United States and as Minjuvi in the ex-U.S. markets in 2024. Incyte and pa…Read full document

Incyte Corporation INCY reported second-quarter 2026 adjusted earnings of $3.09 per share, which beat the Zacks Consensus Estimate of $2.00, primarily due to higher product sales. The company had reported adjusted earnings of $1.57 per share in the year-ago quarter. Total revenues in the second quarter were $1.67 billion, which grew 38% year over year, driven primarily by the sustained performance of its lead drug, Jakafi (ruxolitinib), and increased sales of Opzelura (ruxolitinib) cream on strong launch and demand. The top line beat the Zacks Consensus Estimate of $1.46 billion. All percentages mentioned below are on a reported basis. Revenues from the sale of Jakafi, a first-in-class JAK1/JAK2 inhibitor approved for polycythemia vera, myelofibrosis and refractory acute graft-versus-host disease (GVHD), came in at $816.7 million, up 7% from the year-ago quarter, owing to a 9% increase in paid demand and growth across all indications. Jakafi's sales beat the Zacks Consensus Estimate of $798 million. Opzelura (ruxolitinib) cream, approved for atopic dermatitis and vitiligo, generated $449.7 million in sales, which rose 173% year over year, beating the Zacks Consensus Estimate of $277.8 million. The massive uptick was driven by a one-time, non-cash benefit of $246 million associated with the reversal of previously established accrual balances through March 31, 2026, for Opzelura, as well as by increased patient demand in both approved indications. The newly approved medicine Zynyz (retifanlimab-dlwr) generated sales of $49.9 million, which significantly increased from the year-ago quarter and beat the Zacks Consensus Estimate of $43.8 million. The company obtained accelerated approval for Zynyz to treat metastatic or recurrent locally advanced Merkel cell carcinoma. Net product revenues of Iclusig were $34.4 million, up 5% year over year. The figure missed the Zacks Consensus Estimate of $35.5 million. Pemazyre generated $23.4 million in sales, reflecting a year-over-year increase of 6%. The figure surpassed the Zacks Consensus Estimate of $22.4 million. Minjuvi's revenues totaled $53.7 million, up 72% year over year. The figure beat the Zacks Consensus Estimate of $50.6 million. Incyte gained exclusive global rights for tafasitamab from MorphoSys AG, which is marketed as Monjuvi in the United States and as Minjuvi in the ex-U.S. markets in 2024. Incyte and partner Syndax Pharmaceuticals obtained FDA approval for axatilimab-csfr, an anti-CSF-1R antibody, for the treatment of GVHD after the failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. The candidate was approved under the brand name Niktimvo. The drug is Incyte’s second approved treatment for chronic GVHD (third-line) and was launched in the United States during the first quarter of 2025. The drug recorded $60.3 million in sales in the second quarter of 2026, up 67% on a year-over-year basis, driven by strong uptake, but missed the Zacks Consensus Estimate of $63.8 million. Shares of Incyte have rallied 20.3% year to date compared with the industry’s 2% growth. Image Source: Zacks Investment Research Jakafi is marketed by Incyte in the United States and by Novartis NVS as Jakavi in ex-U.S. markets. Jakavi royalty revenues from Novartis for commercialization in ex-U.S. markets rose 13% to $124.2 million. Jakavi royalties beat the Zacks Consensus Estimate of $117 million. Incyte also receives royalties from the sales of Tabrecta (capmatinib) for the treatment of adult patients with metastatic non-small-cell lung cancer. Its partner, Novartis, has exclusive worldwide development and commercialization rights for Tabrecta. Royalty revenues from the drug’s sales amounted to $6.7 million, up 1% year over year. The reported figure missed the Zacks Consensus Estimate of $7.1 million. Olumiant’s (baricitinib) product royalty revenues from Eli Lilly LLY totaled $38.5 million, up 15% year over year. The figure beat the Zacks Consensus Estimate of $36.9 million. Incyte has a collaboration agreement with Eli Lilly for Olumiant. The drug is a once-daily oral JAK inhibitor discovered by Incyte and licensed to LLY. It is approved for several types of autoimmune diseases. Adjusted research and development (R&D) expenses totaled $478.8 million, up 5% year over year. This increase was primarily due to continued investment in late-stage development assets. Adjusted selling, general and administrative (SG&A) expenses were $323.6 million, up 6% from the prior-year quarter’s number, primarily due to increased consumer marketing and pre-launch activities. INCY’s cash, cash equivalents and marketable securities amounted to $4.5 billion as of June 30, 2026, compared with the $4 billion recorded as of March 31, 2026. Incyte Corporation price-consensus-eps-surprise-chart | Incyte Corporation Quote While Incyte continues to expect Jakafi revenues in the range of $3.22-$3.27 billion in 2026, it now expects Opzelura net product revenues to be in the range of $1.05-$1.1 billion, up from the previously guided range of $750-$790 million. Net product revenues for 2026 are now expected to be in the range of $5.13-$5.26 billion, up from the previously guided range of $4.77-$4.94 billion. Total adjusted R&D expenses and SG&A expenses for 2026 are now expected in the range of$4.625 - $4.695 billion compared with the previous guidance of $3.205-$3.375 billion. Incyte currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Neurocrine Biosciences NBIX,carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Over the past 60 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have decreased from $9.15 to $9.09. Over the same period, EPS estimates for 2027 have increased from $10.23 to $10.81. NBIX shares have gained 24.4% year to date. Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Incyte Corporation (INCY) : Free Stock Analysis Report Novartis AG (NVS) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report Neurocrine Biosciences, Inc. (NBIX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-07-28

Incyte Q2 Earnings Call Highlights

MarketBeat
Interested in Incyte Corporation? Here are five stocks we like better. Strong Q2 performance: Incyte reported $1.49 billion in net product sales, up 40% year over year, though results included a $246 million one-time OPZELURA-related benefit. Excluding that benefit, sales rose 17%, prompting the company to raise its 2026 revenue outlook to $5.13 billion–$5.26 billion. Growth broadens beyond Jakafi: Jakafi sales increased 7% to $817 million, while the business excluding Jakafi grew 127% to $671 million. OPZELURA, Niktimvo, MONJUVI and ZYNYZ all posted significant gains, with higher 2026 guidance for OPZELURA and the hematology-oncology portfolio. Pipeline expansion comes with higher costs: Incyte acquired Vega Therapeutics and its phase III von Willebrand disease candidate latarcibart, while advancing several pivotal programs and discontinuing a non-differentiated JAK2 program. The transaction and development investments lifted 2026 operating-expense guidance to $4.915 billion–$4.995 billion. Can Incyte Deliver on 447% EPS Forecasts and Pipeline Hype? Incyte (NASDAQ:INCY) reported second-quarter 2026 net product sales of $1.49 billion, up 40% from a year earlier, supported by demand growth across its marketed portfolio and a one-time non-cash benefit tied to the resolution of a CMS matter involving OPZELURA. Excluding the $246 million one-time benefit, total net sales increased 17% year over year, Chief Executive Officer Bill Meury said on the company’s earnings call. Meury said every marketed product recorded year-over-year growth in both U.S. and international markets. → Volatility Is Back and These 3 Market Tollbooths Are Best Positioned to Profit 5 top healthcare stocks for earnings growth in 2024 The company raised its full-year 2026 total net sales outlook to a range of $5.13 billion to $5.26 billion. It also increased OPZELURA sales guidance and narrowed and raised its outlook for the hematology and oncology portfolio. Jakafi second-quarter sales were $817 million, up 7% from the prior-year period. Prescription demand increased 9% across myelofibrosis, polycythemia vera and graft-versus-host disease, with polycythemia vera serving as the largest growth driver, Meury said. → This Tiny AI Supplier Could Be More Important Than the Chipmakers Argenx's 28% Surge & Promising Product Propel Investor Confidence Incyte recently launched Jakafi XR, an extended-r…Read full document

Interested in Incyte Corporation? Here are five stocks we like better. Strong Q2 performance: Incyte reported $1.49 billion in net product sales, up 40% year over year, though results included a $246 million one-time OPZELURA-related benefit. Excluding that benefit, sales rose 17%, prompting the company to raise its 2026 revenue outlook to $5.13 billion–$5.26 billion. Growth broadens beyond Jakafi: Jakafi sales increased 7% to $817 million, while the business excluding Jakafi grew 127% to $671 million. OPZELURA, Niktimvo, MONJUVI and ZYNYZ all posted significant gains, with higher 2026 guidance for OPZELURA and the hematology-oncology portfolio. Pipeline expansion comes with higher costs: Incyte acquired Vega Therapeutics and its phase III von Willebrand disease candidate latarcibart, while advancing several pivotal programs and discontinuing a non-differentiated JAK2 program. The transaction and development investments lifted 2026 operating-expense guidance to $4.915 billion–$4.995 billion. Can Incyte Deliver on 447% EPS Forecasts and Pipeline Hype? Incyte (NASDAQ:INCY) reported second-quarter 2026 net product sales of $1.49 billion, up 40% from a year earlier, supported by demand growth across its marketed portfolio and a one-time non-cash benefit tied to the resolution of a CMS matter involving OPZELURA. Excluding the $246 million one-time benefit, total net sales increased 17% year over year, Chief Executive Officer Bill Meury said on the company’s earnings call. Meury said every marketed product recorded year-over-year growth in both U.S. and international markets. → Volatility Is Back and These 3 Market Tollbooths Are Best Positioned to Profit 5 top healthcare stocks for earnings growth in 2024 The company raised its full-year 2026 total net sales outlook to a range of $5.13 billion to $5.26 billion. It also increased OPZELURA sales guidance and narrowed and raised its outlook for the hematology and oncology portfolio. Jakafi second-quarter sales were $817 million, up 7% from the prior-year period. Prescription demand increased 9% across myelofibrosis, polycythemia vera and graft-versus-host disease, with polycythemia vera serving as the largest growth driver, Meury said. → This Tiny AI Supplier Could Be More Important Than the Chipmakers Argenx's 28% Surge & Promising Product Propel Investor Confidence Incyte recently launched Jakafi XR, an extended-release version of the product. Jakafi XR generated $10 million in second-quarter sales, primarily from initial inventory build. The company expects full-year XR sales of approximately $40 million to $50 million, included within its broader Jakafi guidance. Mohamed Issa, executive vice president and head of U.S. Commercial, said payer reimbursement has begun and several major insurers have placed Jakafi XR on formulary. Incyte is targeting 50% to 70% formulary coverage by year-end and expects the extended-release product to represent roughly 3% to 5% of demand by December. → 2 Stocks Built to Thrive If Inflation Refuses to Fade Sales from Incyte’s business excluding Jakafi totaled $671 million, up 127% year over year. Excluding the one-time OPZELURA benefit, the segment grew 44%. Meury said the company remains on track toward its objective of generating $3 billion to $4 billion in net sales from the core business excluding Jakafi by 2030. OPZELURA contributed $450 million in second-quarter sales, including $204 million in net product sales and the $246 million non-cash benefit associated with the CMS settlement and the reversal of previously accrued balances related to Medicaid rebate litigation. U.S. OPZELURA sales excluding the one-time benefit rose 22% to $161 million. Prescription volume increased 26%, compared with 21% growth for the overall market, according to Meury. The company said OPZELURA captured 46% of branded topical new prescription volume. The CMS resolution improved the product’s average selling price and gross-to-net profile, Meury said. He said the gross-to-net rate moved from the low 60% range to the high 50% range. Incyte now expects $1.05 billion to $1.10 billion in full-year OPZELURA sales, including an estimated $300 million to $310 million impact from the settlement. International OPZELURA sales rose 34% to $43 million. The company expects a final European Commission decision for OPZELURA in moderate atopic dermatitis during the third quarter after receiving a positive opinion from the Committee for Medicinal Products for Human Use in June. Hematology and oncology sales increased 69% to $222 million. Niktimvo generated $60 million in sales, up 67%, with more than 300 new patients initiating therapy during the quarter and more than 1,200 patients treated. Incyte said it holds approximately one-third of the third-line-and-beyond market. MONJUVI sales increased 72% to $54 million, driven primarily by uptake in follicular lymphoma in international markets, including Japan following a recent approval and launch. ZYNYZ sales rose fourfold to $50 million, with the company reporting more than a 40% share in first-line squamous cell carcinoma of the anal canal in the U.S. 12 months after launch. Incyte narrowed and raised its 2026 hematology and oncology sales forecast to $860 million to $890 million. The company said it has advanced 13 of 15 planned pivotal studies, with the remaining two expected to begin by year-end. Regulatory reviews are ongoing for povorcitinib in hidradenitis suppurativa and tafasitamab in newly diagnosed diffuse large B-cell lymphoma, with potential approvals and launches beginning later in 2026 and extending into 2027. Incyte also acquired Vega Therapeutics, adding latarcibart, a phase III treatment candidate for von Willebrand disease. Pablo Cagnoni, Incyte’s president and global head of research and development, said data from the VIVID-3 study showed an 81% median reduction in annualized bleeding rate across patients with different von Willebrand disease subtypes and bleeding types. Top-line data from the phase III VIVID-6 trial are expected by early 2029. Meanwhile, Incyte discontinued development of its 058 program targeting JAK2 V617F in myeloproliferative neoplasms. Cagnoni said the company concluded that the molecule did not demonstrate the profile needed to be a differentiated therapy, though Incyte continues to view JAK2 V617F as an important target and is prioritizing next-generation programs. The company plans to present expanded early-stage data for its KRAS G12D inhibitor, INCB161734, its TGF-beta receptor 2 by PD-1 bispecific antibody, and its CDK2 inhibitor at the European Society for Medical Oncology Congress in October. GAAP operating expenses were $976 million in the quarter, up 42% from a year earlier. Incyte said the comparison reflected a lower prior-year expense base following a $242 million Novartis settlement in the second quarter of 2025. Excluding that favorable adjustment, operating expenses rose 5%. GAAP research and development expense increased 4% to $517 million, while selling, general and administrative expense rose 6% to $352 million, driven in part by pre-launch activities for povorcitinib. The company ended the quarter with $4.5 billion in cash and cash equivalents, including the impact of the Vega acquisition completed in July. Incyte raised its 2026 GAAP R&D and SG&A expense outlook to $4.915 billion to $4.995 billion. The revised forecast includes approximately $1.27 billion related to the Vega transaction’s upfront in-process research and development payment and transaction costs, as well as roughly $50 million for continued phase III development of latarcibart. Incyte Corporation is a Wilmington, Delaware–based biopharmaceutical company focused on the discovery, development and commercialization of novel therapies in oncology and inflammation. Since its founding in 2002, Incyte has grown from a small research organization into a global enterprise, advancing a portfolio of internally developed and partnered assets. The company's research and development efforts center on small-molecule drugs and biologics that modulate critical signaling pathways implicated in cancer, autoimmune disorders and rare diseases. The company's flagship product is Jakafi® (ruxolitinib), a Janus kinase (JAK) inhibitor approved for the treatment of myelofibrosis and polycythemia vera. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Incyte Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.

Investor releaseQuarter not tagged2026-07-28

Incyte Tops Second-Quarter Expectations but Shares Slip on Lower Revenue Outlook

InvestorsHub

Incyte (NASDAQ:INCY) reported better-than-expected second-quarter earnings and revenue on Tuesday, although its shares edged lower in pre-market trading after the company issued full-year sales guidance that came in below analysts’ expectations. The biotechnology group delivered strong growth across its commercial portfolio, supported by higher sales from several key products and continued pipeline progress. Adjusted earnings per share reached $3.09 during the second quarter, exceeding analyst expectations by $1.10. Revenue rose to $1.67 billion, comfortably ahead of the consensus estimate of $1.42 billion. Total revenue increased 38% compared with the same period last year, while total net sales climbed 40% to $1.49 billion. The reported figures included a one-time, non-cash benefit of $246 million linked to an agreement with the Centers for Medicare & Medicaid Services relating to Opzelura. Excluding that benefit, total net sales grew 17% year over year. Jakafi generated net sales of $817 million, representing annual growth of 7%. Opzelura recorded net sales of $450 million, an increase of 173%. Excluding the benefit from the CMS agreement, Opzelura sales rose 24%. Meanwhile, Incyte’s Haematology and Oncology portfolio produced net sales of $222 million, up 69% from the second quarter of 2025. “Our second quarter was marked by broad-based sales growth, continued pipeline progress and strategic business development,” said Bill Meury, Chief Executive Officer of Incyte. “Every marketed product contributed to growth, reflecting the strength of our commercial portfolio and execution.” Incyte raised its forecast for total net sales in 2026 to a range of $5.13 billion to $5.26 billion. However, the midpoint of the updated guidance remained below the analyst consensus estimate of $5.72 billion, weighing on investor sentiment despite the quarterly earnings beat. Management said the revised outlook reflects the impact of the CMS agreement as well as continued momentum from growth products including Niktimvo, Monjuvi/Minjuvi and Zynyz. The company also increased its full-year operating expense guidance following the acquisition of Vega Therapeutics. As part of the transaction, Incyte expects to record approximately $1.27 billion of in-process research and development expense during the third quarter. Incyte stock price

Investor releaseQuarter not tagged2026-07-28

Incyte Corp (INCY) Q2 2026 Earnings Call Highlights: Robust Revenue Growth and Strategic ...

GuruFocus.com
This article first appeared on GuruFocus. Total Revenue: $1.67 billion, up 38% year over year. Total Net Sales: $1.49 billion, representing 40% growth year over year. Jakafi Sales: $817 million, up 7% year over year. Opzelura Sales: $450 million in the second quarter, including a $246 million one-time non-cash benefit. Core Business Sales (Excluding Jakafi): $671 million, up 127% year over year. Hematology and Oncology Net Sales: $222 million, up 69% year over year. GAAP Expenses: $976 million, an increase of 42% compared to the prior year. Cash and Cash Equivalents: $4.5 billion at the end of the quarter. Full Year 2026 Total Net Sales Guidance: Raised to $5.130 billion to $5.260 billion. Opzelura Full Year 2026 Net Sales Guidance: Updated to $1.050 billion to $1.100 billion. Hematology and Oncology Full Year Guidance: Narrowed and raised to $860 million to $890 million. Warning! GuruFocus has detected 5 Warning Signs with RGEN. Is INCY fairly valued? Test your thesis with our free DCF calculator. Release Date: July 28, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Incyte Corp (NASDAQ:INCY) reported a 38% year-over-year increase in total revenue for the second quarter of 2026, reaching $1.67 billion. The company achieved several key regulatory milestones, including the approval and launch of Jakafi XR and a positive CHMP opinion for Opzelura in moderate atopic dermatitis. Incyte Corp (NASDAQ:INCY) has diversified its pipeline with multiple late-stage developments, including new Phase 3 studies and the acquisition of a novel hematology asset, latarcibart, for Von Willebrand's disease. The core business, excluding Jakafi, showed significant growth with sales up 127% year over year, driven by strong performance of products like Opzelura. The company has a strong cash position with $4.5 billion in cash and cash equivalents, providing financial flexibility for future growth initiatives. Despite strong overall performance, Jakafi sales growth was relatively modest at 7% year over year, indicating potential challenges in maintaining momentum for this cornerstone product. The company faces a dynamic pricing and reimbursement environment, particularly for Opzelura, which requires ongoing strategic management to sustain growth. Incyte Corp (NASDAQ:INCY) discontinued development of its JAK2V617F targeted pipe…Read full document

This article first appeared on GuruFocus. Total Revenue: $1.67 billion, up 38% year over year. Total Net Sales: $1.49 billion, representing 40% growth year over year. Jakafi Sales: $817 million, up 7% year over year. Opzelura Sales: $450 million in the second quarter, including a $246 million one-time non-cash benefit. Core Business Sales (Excluding Jakafi): $671 million, up 127% year over year. Hematology and Oncology Net Sales: $222 million, up 69% year over year. GAAP Expenses: $976 million, an increase of 42% compared to the prior year. Cash and Cash Equivalents: $4.5 billion at the end of the quarter. Full Year 2026 Total Net Sales Guidance: Raised to $5.130 billion to $5.260 billion. Opzelura Full Year 2026 Net Sales Guidance: Updated to $1.050 billion to $1.100 billion. Hematology and Oncology Full Year Guidance: Narrowed and raised to $860 million to $890 million. Warning! GuruFocus has detected 5 Warning Signs with RGEN. Is INCY fairly valued? Test your thesis with our free DCF calculator. Release Date: July 28, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Incyte Corp (NASDAQ:INCY) reported a 38% year-over-year increase in total revenue for the second quarter of 2026, reaching $1.67 billion. The company achieved several key regulatory milestones, including the approval and launch of Jakafi XR and a positive CHMP opinion for Opzelura in moderate atopic dermatitis. Incyte Corp (NASDAQ:INCY) has diversified its pipeline with multiple late-stage developments, including new Phase 3 studies and the acquisition of a novel hematology asset, latarcibart, for Von Willebrand's disease. The core business, excluding Jakafi, showed significant growth with sales up 127% year over year, driven by strong performance of products like Opzelura. The company has a strong cash position with $4.5 billion in cash and cash equivalents, providing financial flexibility for future growth initiatives. Despite strong overall performance, Jakafi sales growth was relatively modest at 7% year over year, indicating potential challenges in maintaining momentum for this cornerstone product. The company faces a dynamic pricing and reimbursement environment, particularly for Opzelura, which requires ongoing strategic management to sustain growth. Incyte Corp (NASDAQ:INCY) discontinued development of its JAK2V617F targeted pipeline asset '058 due to insufficient differentiation, highlighting challenges in its R&D efforts. The company anticipates potential margin compression as it invests heavily in R&D and product launches, which could impact profitability in the short term. There is uncertainty around the regulatory path for '989 in myelofibrosis, as discussions with the FDA are ongoing regarding potential endpoints and trial designs. Q: Can you review the major questions still awaiting resolution on the CALR program's trial design in myelofibrosis (MF)? A: Pablo Cagnoni, President of Research and Development, explained that there are two regulatory paths for MF: a standard path with SVR35 and TSS50 as endpoints, and an alternative path with additional endpoints. The latter is being discussed with the FDA due to '989's novel mechanism of action and its benefits, such as improving hemoglobin levels. Conversations with the FDA are ongoing, and the company plans to start studies in MF this year. Q: How do you feel about the breadth and depth of your pipeline after the Vega acquisition? A: William Meury, CEO, stated that they are actively looking for opportunities that meet strategic and financial criteria, similar to the Vega acquisition. The focus is on maintaining a moving product line and pipeline. R&D investments are concentrated on high-potential assets, and any margin compression would need to correlate with increased pipeline value. Key assets like povorcitinib, '989, G12D, and VGA039 are seen as potential drivers beyond Jakafi. Q: Can you provide more details on the collaboration with Halozyme for '989? A: Pablo Cagnoni explained that the collaboration with Halozyme is to add optionality and improve patient experience with '989's subcutaneous formulation. The existing subcutaneous program is progressing, and the Halozyme technology provides additional flexibility. The collaboration is not due to any emerging data but is aimed at optimizing administration. Q: What are your expectations for the G12D update at ESMO, and how do you view competitive positioning? A: Pablo Cagnoni expressed confidence in '734, the G12D inhibitor, as a highly selective and potent medicine. The ESMO presentation will include data from approximately 50 patients in pancreatic cancer, showing efficacy and safety. The Phase 3 study is ongoing, and the company believes they are competitive in the field. The program is also exploring opportunities in colorectal cancer. Q: What is the potential for latarcibart to expand beyond Von Willebrand's disease (VWD)? A: David Gardner, Executive Vice President and Chief Strategy Officer, noted that feedback from KOLs and patient advocacy groups was positive. There is potential for latarcibart to deliver a transformative Hemlibra-like opportunity for patients. William Meury added that if latarcibart shows substantial reduction in annual bleed rate, it could become a large product for Incyte. Q: How is the Jakafi XR conversion tracking, and when will payer reimbursement impact earnings? A: Mohamed Issa, Executive Vice President, Head of US Oncology, stated that Jakafi XR is on track to achieve 50% to 70% formulary coverage by year-end. Payer reimbursement has already started, and demand is picking up. The goal is to have XR represent 3% to 5% of demand by year-end, leading to $40 million to $50 million in sales, setting up for further growth in 2027. Q: What benchmarks should be used to judge success for '734 in PDAC and CRC data at ESMO? A: Pablo Cagnoni mentioned that benchmarks include existing chemotherapy response rates and competitor data. The ESMO presentation will provide data from 50 patients in pancreatic cancer, showing efficacy and safety. The company believes '734 has the potential to be best-in-class in combination with chemotherapy for first-line pancreatic cancer and in colorectal cancer. Q: What is the regulatory plan for povorcitinib in vitiligo? A: Pablo Cagnoni stated that the plan is to submit the regulatory filing after the approval in hidradenitis suppurativa (HS) with two years of safety data in vitiligo patients. The submission is expected early next year. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-07-28

Compared to Estimates, Incyte (INCY) Q2 Earnings: A Look at Key Metrics

Zacks
For the quarter ended June 2026, Incyte (INCY) reported revenue of $1.67 billion, up 37.7% over the same period last year. EPS came in at $3.09, compared to $1.57 in the year-ago quarter. The reported revenue represents a surprise of +14.71% over the Zacks Consensus Estimate of $1.46 billion. With the consensus EPS estimate being $2.00, the EPS surprise was +54.5%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health. As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately. Here is how Incyte performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenues- Net sales: $1.49 billion versus $1.29 billion estimated by eight analysts on average. Compared to the year-ago quarter, this number represents a +40.5% change. Revenues- Product royalty revenues: $174.69 million versus the eight-analyst average estimate of $162.52 million. The reported number represents a year-over-year change of +15.6%. Net sales- Iclusig: $34.39 million versus $35.49 million estimated by eight analysts on average. Compared to the year-ago quarter, this number represents a +5.1% change. Net sales- Pemazyre: $23.42 million compared to the $22.42 million average estimate based on eight analysts. The reported number represents a change of +5.5% year over year. Net sales- Minjuvi/ Monjuvi: $53.69 million versus the eight-analyst average estimate of $50.59 million. The reported number represents a year-over-year change of +72.5%. Net sales- Opzelura: $449.74 million versus $277.8 million estimated by eight analysts on average. Compared to the year-ago quarter, this number represents a +173.4% change. Net sales- Jakafi: $816.66 million versus the eight-analyst average estimate of $797.99 million. The reported number represents a year-over-year change of +6.9%. Net sales- Niktimvo: $60.31 million versus the seven-analyst average estimate of $63.8 million. The reported number represents a year-over-year change of +66.8%. Net sales- Zynyz: $49.95 million compared to the $43.83 million average estimate based on…Read full document

For the quarter ended June 2026, Incyte (INCY) reported revenue of $1.67 billion, up 37.7% over the same period last year. EPS came in at $3.09, compared to $1.57 in the year-ago quarter. The reported revenue represents a surprise of +14.71% over the Zacks Consensus Estimate of $1.46 billion. With the consensus EPS estimate being $2.00, the EPS surprise was +54.5%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health. As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately. Here is how Incyte performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenues- Net sales: $1.49 billion versus $1.29 billion estimated by eight analysts on average. Compared to the year-ago quarter, this number represents a +40.5% change. Revenues- Product royalty revenues: $174.69 million versus the eight-analyst average estimate of $162.52 million. The reported number represents a year-over-year change of +15.6%. Net sales- Iclusig: $34.39 million versus $35.49 million estimated by eight analysts on average. Compared to the year-ago quarter, this number represents a +5.1% change. Net sales- Pemazyre: $23.42 million compared to the $22.42 million average estimate based on eight analysts. The reported number represents a change of +5.5% year over year. Net sales- Minjuvi/ Monjuvi: $53.69 million versus the eight-analyst average estimate of $50.59 million. The reported number represents a year-over-year change of +72.5%. Net sales- Opzelura: $449.74 million versus $277.8 million estimated by eight analysts on average. Compared to the year-ago quarter, this number represents a +173.4% change. Net sales- Jakafi: $816.66 million versus the eight-analyst average estimate of $797.99 million. The reported number represents a year-over-year change of +6.9%. Net sales- Niktimvo: $60.31 million versus the seven-analyst average estimate of $63.8 million. The reported number represents a year-over-year change of +66.8%. Net sales- Zynyz: $49.95 million compared to the $43.83 million average estimate based on seven analysts. The reported number represents a change of +459.9% year over year. Royalty revenues- Olumiant: $38.48 million versus the seven-analyst average estimate of $36.87 million. The reported number represents a year-over-year change of +14.9%. Royalty revenues- Tabrecta: $6.69 million versus $7.11 million estimated by seven analysts on average. Compared to the year-ago quarter, this number represents a +0.9% change. Royalty revenues- Jakavi: $124.19 million versus the seven-analyst average estimate of $116.95 million. The reported number represents a year-over-year change of +13.2%. View all Key Company Metrics for Incyte here>>> Shares of Incyte have returned +3.7% over the past month versus the Zacks S&P 500 composite's +1.7% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Incyte Corporation (INCY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-07-28

Incyte (INCY) Q2 Earnings and Revenues Top Estimates

Zacks
Incyte (INCY) came out with quarterly earnings of $3.09 per share, beating the Zacks Consensus Estimate of $2 per share. This compares to earnings of $1.57 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +54.50%. A quarter ago, it was expected that this specialty drugmaker would post earnings of $1.38 per share when it actually produced earnings of $1.81, delivering a surprise of +31.16%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Incyte, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $1.67 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 14.71%. This compares to year-ago revenues of $1.22 billion. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Incyte shares have added about 20.4% since the beginning of the year versus the S&P 500's gain of 8.3%. While Incyte has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Incyte was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stock…Read full document

Incyte (INCY) came out with quarterly earnings of $3.09 per share, beating the Zacks Consensus Estimate of $2 per share. This compares to earnings of $1.57 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +54.50%. A quarter ago, it was expected that this specialty drugmaker would post earnings of $1.38 per share when it actually produced earnings of $1.81, delivering a surprise of +31.16%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Incyte, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $1.67 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 14.71%. This compares to year-ago revenues of $1.22 billion. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Incyte shares have added about 20.4% since the beginning of the year versus the S&P 500's gain of 8.3%. While Incyte has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Incyte was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.04 on $1.47 billion in revenues for the coming quarter and $7.87 on $5.73 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 38% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Keros Therapeutics, Inc. (KROS), has yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $1.25 per share in its upcoming report, which represents a year-over-year change of -64.5%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Keros Therapeutics, Inc.'s revenues are expected to be $0.35 million, down 98.1% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Incyte Corporation (INCY) : Free Stock Analysis Report Keros Therapeutics, Inc. (KROS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

TranscriptFY2026 Q22026-07-28

FY2026 Q2 earnings call transcript

Earnings source - 164 paragraphs
Operator

Good evening, welcome to the Incyte Second Quarter 2026 Earnings Conference Call Webcast. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star one on your telephone keypad. We ask you please limit yourselves to one question, then return to the queue.

Operator

As a reminder, this conference is being recorded. If anyone should require operator assistance, please press star zero. It's now my pleasure to turn the call over to Alexis Smith, Vice President, Head of Investor Relations. Please go ahead, Alexis.

Alexis Smith

Thank you. Good morning. Welcome to Incyte's second quarter 2026 earnings conference call. Before we begin, I encourage everyone to go to the Investors section of our website to find the press release, related financial tables, and slides that follow today's discussion. On today's call, I am joined by Bill, Pablo, and Suky, who will deliver our prepared remarks.

Alexis Smith

Steven, Dave, and Mohamed will also be available for Q&A. I would like to point out that we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties. Our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. I'll now hand the call over to Bill.

Bill Meury

Thank you, Alexis. Good morning, everyone. At the start of the year, we laid out a plan to move Incyte from reliance on a cornerstone product to a company with multiple growth drivers. Six months in, this transition is well underway. We've made tangible progress. We've strengthened the core business, delivered key regulatory milestones, de-risked and advanced our pipeline to late-stage development. We added a novel phase III hematology asset through business development.

Bill Meury

Let me expand on each. First, our business continues to perform above expectations. Total net sales growth was driven by increased demand and higher net sales across every product. Jakafi remains foundational to the company and delivered another strong quarter. Keeping this product healthy is a strategic priority because it serves as a funding vehicle for the pipeline and new product launches.

Bill Meury

At the same time, our core business, excluding Jakafi, continues to grow and is solidly on track to reach $3 billion-$4 billion in net sales by 2030. Importantly, this growth is not dependent on a single asset but is supported by multiple products and near-term launches. We have the commercial capabilities, resources, infrastructure, and management team required to execute successfully.

Bill Meury

The opportunity here is not simply the value of each individual product, but our ability to launch and scale multiple products in parallel. This capability will be a key driver of Incyte's next phase of growth. Second, we achieved several of the key regulatory milestones we identified at the beginning of the year, including the approval and launch of Jakafi XR, as well as the positive CHMP opinion of Opzelura in moderate AD, with the final European Commission decision and signature expected in the third quarter.

Bill Meury

In addition, regulatory reviews for povorcitinib in HS and MONJUVI in first-line DLBCL are underway, with anticipated approvals and launches through early 2027. Third, we moved multiple assets into late-stage development. We launched phase III studies for INCA033989 in second-line ET, INCB161734 in PDAC, and INCA33890 in CRC. We also have a catalyst-rich second half of the year with 10 data readouts across nearly all assets in our clinical pipeline, including data from our registration trials for Opzelura in HS and povorcitinib in PN.

Bill Meury

As these programs advance, we are gaining greater visibility into the potential shape of our growth profile beyond 2029. We also strengthened our hematology portfolio through business development. The Vega Therapeutics transaction added latarcibart, a potentially transformative treatment for von Willebrand disease in phase III development and a potential new growth driver for the company.

Bill Meury

latarcibart expands our most important therapeutic franchise, offers an attractive risk-reward profile, and the transaction was structured to preserve balance sheet flexibility. It checked all the boxes we looked for in business development and is a textbook example of the type of deal that makes sense for Incyte. Taken together, Incyte is no longer dependent on one asset, catalyst, or blockbuster.

Bill Meury

We now have a solid core business, a series of near-term launches, and a more mature late-stage pipeline supporting multiple avenues for future growth. Operationally, we're a stronger organization than we were a year ago. Our focus right now is execution, turning phase III studies into approvals and approvals into successful launches. Turning to the quarter. Total revenue in the second quarter of 2026 was $1.67 billion, up 38% year-over-year.

Bill Meury

Total net sales in the second quarter were $1.49 billion, representing 40% growth year-over-year. The increase was driven by continued demand across the portfolio and by a one-time non-cash benefit from the CMS settlement. Excluding this benefit, total net sales increased 17%. This growth was broad-based, with every marketed product growing year-over-year in both the U.S. and international markets. Jakafi sales in the second quarter were $817 million, up 7% year-over-year.

Bill Meury

Prescription demand for Jakafi increased 9% across all indications, MF, PV, and GVHD, with PV being the largest growth driver. New patient starts remain strong. The prescriber base is stable, and formulary coverage is broad, providing an important foundation for the Jakafi XR launch. A few comments on XR. The launch has two parts, coverage and adoption.

Bill Meury

On coverage, we're on track to achieve our year-end formulary goal of 50%-70%, supported by recent wins at ESI, CVS Health, Optum, and more than 10 regional plans. On adoption, we expect physician adoption to build gradually through the remainder of 2026 as coverage expands and physicians gain experience with XR, with acceleration expected throughout 2027. Commercially, XR generated $10 million in sales in the second quarter, which primarily consists of initial inventory build.

Bill Meury

We expect XR sales to approach $40 million-$50 million for the full year, which is captured in our full-year Jakafi guidance. Sales for our core business, excluding Jakafi, were $671 million, up 127% year-over-year. Excluding the one-time Opzelura benefit, sales grew 44%. This business is becoming an increasingly important part of how we transition Incyte through the LOE period and for long-term growth.

Bill Meury

Opzelura remains the largest contributor of business outside of Jakafi, generating $450 million in second quarter sales. This includes $204 million of net product sales and a one-time non-cash benefit of $246 million related to our agreement with CMS and the reversal of previously accrued balances associated with the resolution of Medicaid rebate litigation. In the U.S., sales excluding the one-time benefit were $161 million, an increase of 22% versus the second quarter of 2025.

Bill Meury

Demand here remains strong, with prescriptions increasing 26% year-over-year, which outpaced the overall market, which grew 21%. New patient starts also remain strong, with Opzelura capturing 46% of branded topical NBRx volume, a leading indicator of future growth and business health. The resolution of the CMS matter improves the economics of the business, resulting in a favorable change to our average selling price and gross-to-net profile.

Bill Meury

It effectively offsets some of the investment we made to expand and maintain formulary access at the beginning of the year. As a result, prescription growth should translate more efficiently into net sales growth going forward. That said, we continue to view the pricing and reimbursement environment as dynamic, so maintaining broad access and a disciplined gross-to-net profile remains a priority. Opzelura is in a stronger position today than it was a year ago.

Bill Meury

Demand is robust, and access is broad, and while we're encouraged by this momentum, this is not a business we can put on autopilot. Sustaining growth will require effective commercial execution and continued focus on the access and pricing dynamics that support growth. Internationally, Opzelura sales were $43 million in the second quarter, up 34% year-over-year. Growth remains robust in vitiligo, where we see strong demand across markets.

Bill Meury

We remain on track for potential approval and launch of Opzelura for moderate atopic dermatitis in Europe during the third quarter. We expect modest revenue contribution in 2026, with momentum building through 2027 as additional countries launch and reimbursement expands. We continue to view the international expansion of Opzelura as an important long-term growth driver for the franchise, with the potential to deliver 2x to 3x the international sales today. Finally, in hematology and oncology, net sales grew 69% to $222 million.

Bill Meury

Niktimvo, MONJUVI, ZYNYZ were the biggest contributors to growth in the quarter. Niktimvo net sales were $60 million in the second quarter of 2026, representing a 67% increase versus the prior year. The performance was entirely volume growth-based. More than 300 new patients initiating therapy during the quarter and more than 1,200 patients treated. We currently hold approximately one-third of the third-line plus market.

Bill Meury

MONJUVI net sales were $54 million in second quarter, up 72% year-over-year. Growth was primarily driven by uptake in follicular lymphoma in international markets, including the recent approval and launch in Japan in the second quarter. MONJUVI is expected to have three sources of growth, relapse refractory DLBCL, follicular lymphoma, and potentially first-line DLBCL.

Bill Meury

We expect the existing indications to remain incremental contributors, while first-line DLBCL has the potential to become the largest growth driver for the franchise over time. Finally, ZYNYZ net sales were $50 million in the second quarter, a 4x increase year-over-year, with rapid and robust adoption in SCAC across markets. In the U.S., ZYNYZ is becoming the leading prescribed regimen with over a 40% share in first-line SCAC in just 12 months post-launch. Now I'll turn the call over to Pablo.

Pablo Cagnoni

Thank you, Bill. Good morning, everyone. At the beginning of 2026, we outlined ambitious development plans for the R&D organization, including four anticipated approvals, two new product launches, seven key data readouts, and the execution of 14 pivotal studies across our portfolio. As we have reached the midpoint of the year, I am happy to report that we have made significant progress and remain well-positioned to deliver on the milestones we outlined.

Pablo Cagnoni

In the past 12 months, we have fundamentally changed the maturity of our portfolio, advancing multiple programs from early development into late-stage clinical trials while delivering regulatory submissions and approvals. Today, we have late-stage opportunities across all three of our core franchises, creating multiple opportunities for sustained long-term growth. All regulatory submissions supporting our four anticipated approvals for 2026 are now complete.

Pablo Cagnoni

Jakafi XR was approved in the second quarter, representing the first of our two new product launches planned this year. In June, Opzelura received a positive CHMP opinion for the treatment of patients with moderate atopic dermatitis in Europe, with an approval anticipated in the third quarter. If approved, Opzelura would become the first topical JAK inhibitor treatment available in Europe for moderate AD.

Pablo Cagnoni

Our submissions for povorcitinib in hidradenitis suppurativa and tafasitamab in newly diagnosed diffuse large B-cell lymphoma are under regulatory review, with anticipated approvals and launches beginning later this year and into 2027. Beyond our regulatory progress, we delivered multiple important data readouts across hematology, oncology, and dermatology, including registrational data for tafasitamab in first-line DLBCL and povorcitinib in vitiligo, as well as additional data for INCA033989 in essential thrombocythemia and myelofibrosis.

Pablo Cagnoni

At the same time, we expanded our late-stage pipeline with additional latarcibart and have advanced 13 of our now 15 planned pivotal studies, with the remaining two study initiations expected by year-end. Our teams continue to execute well against our development priorities, positioning the portfolio for both near-term value creation and long-term growth. Importantly, many of our highest value catalysts, including data readouts and regulatory decisions, remain ahead, positioning us for a catalyst-rich second half of the year.

Pablo Cagnoni

With that, I'll now turn to the pipeline. Our hematology strategy combines leadership in established disease areas with first-in-class mutation-directed therapies designed to redefine treatment across graft-versus-host disease, myeloproliferative neoplasms, and now bleeding disorders, with additional latarcibart for von Willebrand disease. In chronic graft-versus-host disease, we continue to advance axatilimab in two studies evaluating its potential use earlier in the treatment paradigm, including in combination with ruxolitinib and in combination with steroids.

Pablo Cagnoni

We remain on track to share top-line data from the phase II study in combination with ruxolitinib in the second half of 2026. Top-line data from the phase III study with steroids is expected in early 2028. We're also advancing a portfolio of molecularly targeted therapies for myeloproliferative neoplasms, or MPNs, focused on the underlying driver mutations of disease.

Pablo Cagnoni

Our MPN strategy is built around targeting the underlying biology of disease through highly selective therapies directed against key disease-driving mutations, CALR and JAK2 V617F. Our portfolio includes INCA033989, a mutant CALR monoclonal antibody in late-stage development, 784, our CALR by CD3 bispecific in an ongoing phase I trial, and next-generation programs in preclinical development. We continue to evaluate emerging data as these programs progress and prioritize those we believe have the strongest profiles and greatest potential for patients.

Pablo Cagnoni

As part of this assessment, we decided to discontinue developing 058, our lead asset in our JAK2 V617F-targeted pipeline, and are no longer expecting to report data later this year. Based on the totality of the data to date, we do not believe the molecule demonstrated the profile necessary to become a differentiated therapy. Importantly, this decision is specific to 058 and does not change our conviction in JAK2 V617F as an important therapeutic target in MPNs. We are prioritizing our next-generation JAK2 V617F-targeted assets.

Pablo Cagnoni

We believe these next-generation programs provide a clear opportunity to realize the promise of selectively targeting JAK2 V617F. These programs are progressing through IND-enabling studies, and we'll plan to share more information, including preclinical data, by the end of the year. Turning to our most advanced MPN program, INCA033989, the first and only mutation-specific therapy to enter late-stage development in CALR-mutated MPNs.

Pablo Cagnoni

Early in the quarter, at the European Hematology Association annual meeting, we presented additional phase I data in mutant CALR-positive patients with ET and MF. As this data has matured, we continue to see evidence supporting the differentiated clinical profile of 989, strengthening our confidence in both the ongoing phase III program and the broader development strategy in MF.

Pablo Cagnoni

As mentioned earlier, our phase III study is now underway in mutant CALR-positive patients with ET who have received prior cytoreductive therapy. In MF, we remain on track to initiate a phase III study in JAK-experienced patients in the second half of this year. We'll provide an update following the completion of regulatory discussions. Additionally, we continue to advance our phase I cohort, evaluating INCA033989, as a first-line treatment for patients with MF, both as monotherapy and in combination with ruxolitinib.

Pablo Cagnoni

We expect to share data from this cohort, along with additional data from the JAK-ineligible cohort previously presented at EHA later this year. We also continue to advance the subcutaneous formulation of INCA033989, and initiate a phase I study in mutant CALR-positive patients in the second quarter. In addition to our ongoing efforts, we recently entered a global collaboration and license agreement with Halozyme to evaluate the subcutaneous formulation of INCA033989, using enhanced technology.

Pablo Cagnoni

This collaboration complements our internal subcutaneous development efforts and provides additional flexibility as we optimize the administration profile of INCA033989, for future commercial use. Earlier this month, we strengthened our hematology portfolio through the acquisition of Vega Therapeutics, adding latarcibart, a novel protein S modulator in phase III development for patients with von Willebrand disease, to our late-stage pipeline.

Pablo Cagnoni

At the International Society on Thrombosis and Haemostasis Congress earlier this month, data from the multi-dose VIVID-3 study evaluating latarcibart in patients with VWD were presented during a featured oral session. In VIVID-3, latarcibart demonstrated an 81% median reduction in annualized bleeding rate across patients with different von Willebrand disease subtypes and bleeding types, along with a favorable tolerability profile.

Pablo Cagnoni

With once-monthly subcutaneous dosing, latarcibart also has the potential to significantly reduce treatment burden compared with current prophylactic therapies, which are typically administered 2x to 3x per week. Taken together, the efficacy, tolerability, and dosing profile, combined with its novel mechanism of action, give us confidence in the potential of latarcibart to establish a new standard of care. Our focus now is on advancing the phase III VIVID-6 trial, and we remain on track to deliver top-line data by early 2029. Turning to our oncology portfolio.

Pablo Cagnoni

All three of our lead solid tumor programs, INCA33890, our TGFβR2 by PD-1 bispecific antibody, 734, our KRAS G12D inhibitor, and 667, our CDK2 inhibitor, are progressing through pivotal development, reflecting the continued maturation of our oncology pipeline. In parallel, we continue to generate data in robust phase I programs, exploring the potential of these assets across different indications, lines of therapy, and combination settings, which will help inform broader development efforts.

Pablo Cagnoni

At the European Society for Medical Oncology Congress in October, we plan to present four rapid oral presentations highlighting phase I data across all three assets. This includes data for 734 in first-line pancreatic and late-line colorectal, INCA33890 in first-line and late-line colorectal, and 667 in recurrent ovarian cancers.

Pablo Cagnoni

These presentations will represent the most comprehensive clinical update we have provided across our leading oncology programs and includes substantially larger and more mature datasets than we have previously shared, providing greater insight into the depth of the clinical efficacy and overall safety, and helping further define the emerging competitive profile of each program. For INCA33890 and 734, the presentations will include data in combination with chemotherapy and in patient populations directly aligned with our ongoing phase III studies.

Pablo Cagnoni

At the same time, the breadth of data across all three programs will help inform potential expansion into additional indications and treatment settings. Now I'd like to turn to our I&I portfolio, where we continue to build a dermatology franchise across both topical and systemic therapies with multiple opportunities for continued expansion. Regulatory and clinical efforts for ruxolitinib cream and povorcitinib continue to progress.

Pablo Cagnoni

We remain on track to report top-line results from our registrational phase III program evaluating ruxolitinib cream in mild to moderate HS by year-end. If positive, this data could support the first topical therapy specifically developed for patients with HS and would further expand Opzelura's role across inflammatory skin diseases. For povorcitinib, we continue to execute a broad development and regulatory strategy designed to support a multi-indication franchise.

Pablo Cagnoni

Povorcitinib is under review for the treatment of moderate to severe HS, and we expect potential approvals in Europe in late 2026 and in the U.S. in the first quarter of 2027. In the first half of the year, we shared positive results from our phase III program in vitiligo. Additionally, we remain on track to report top-line results from our phase III program in prurigo nodularis in the fourth quarter.

Pablo Cagnoni

By year-end, we expect to have delivered six registrational study readouts for ruxolitinib cream and povorcitinib across HS, vitiligo, and PN, further strengthening our dermatology franchise spanning multiple diseases and treatment modalities. To close, we continue to make meaningful progress across our pipeline in 2026, delivering important clinical and regulatory milestones.

Pablo Cagnoni

Our portfolio is broader, more mature, and increasingly diversified, and we expect an active second half of the year with multiple registrational data readouts, regulatory decisions, and development milestones across our three core franchises that we believe will further strengthen our long-term growth trajectory. With that, I'll turn it over to Suky for a financial update on the quarter.

Suky Upadhyay

Thanks, Pablo, good morning, everyone. I'll begin with comments on our second quarter results and then turn to our updated full-year outlook. As Bill mentioned earlier, total revenue in the second quarter was $1.067 billion, an increase of 38% driven by strong product sales. Total net product sales were $1.49 billion, reflecting 40% growth versus the prior year. The increase was driven by strong product demand and a one-time non-cash benefit of $246 million.

Suky Upadhyay

Excluding the one-time benefit, total net sales increased 17% versus the prior year. Total GAAP expenses for the quarter were $976 million, an increase of 42% compared to the prior year. The year-over-year increase reflects a lower expense base in the second quarter of 2025, resulting from the Novartis settlement of $242 million. When we exclude the favorable adjustment in the second quarter of 2025, total operating expenses grew 5%.

Suky Upadhyay

GAAP cost of goods was $105 million, representing 7% of total net sales. This is in line with our expectations, and we expect COGS to be between 8%-9% for the full year. Our GAAP R&D expenses were $517 million, an increase of 4%, driven by continued investment in our late-stage development assets across hematology and oncology.

Suky Upadhyay

Moving to GAAP SG&A. Expenses were $352 million, increasing 6%, driven by pre-launch activities for povorcitinib. We ended the quarter with $4.5 billion in cash and cash equivalents. This includes the close of the Vega Therapeutics acquisition in July, which I'll provide more color on momentarily. Turning to our outlook for the remainder of the year.

Suky Upadhyay

We are updating several components of our existing guidance for the full year, including total net sales, which is driven by guidance updates to Opzelura as well as hematology and oncology, and R&D and SG&A operating expenses driven by the close of the Vega acquisition and related incremental costs in the second half of the year. Starting with net sales, we are raising our full-year 2026 total net sales guidance to $5.13 billion-$5.26 billion.

Suky Upadhyay

For Opzelura, we are updating full-year 2026 net sales guidance to $1.05 billion-$1.10 billion. Our new guidance reflects the previous guidance of $750 million-$790 million and the incremental estimated impact of $300 million-$310 million of net sales related to the CMS settlement. This impact includes two key components. First is a one-time non-cash benefit of $246 million related to Opzelura net sales that was recorded in the second quarter.

Suky Upadhyay

As a reminder, this amount is associated with the reversal of previously established accrual balances through the first quarter of 2026. Second, higher net sales from an improved gross to net profile in the second quarter through the fourth quarter. In the second quarter, the impact of U.S. Opzelura net sales was $15 million.

Suky Upadhyay

This is a net impact after consideration of certain one-time prior year state-related liabilities that became effective at the conclusion of the CMS settlement. On a go-forward basis, we expect the impact to be approximately $40 million-$50 million for the second half of the year. Regarding our hematology and oncology portfolio, we are narrowing and raising full-year guidance range to $860 million-$890 million based on strong performance in the first half of the year. Turning to operating expenses.

Suky Upadhyay

We are updating our full year 2026 operating expense guidance. We are narrowing and raising our 2026 GAAP R&D and SG&A operating expense guidance to $4.915 billion-$4.995 billion. We are also raising total non-GAAP R&D and SG&A operating expenses to $4.625 billion-$4.695 billion.

Suky Upadhyay

The new guidance reflects an increase of approximately $1.27 billion related to the upfront payment for in-process research and development and associated transaction costs in tandem with approximately $50 million in ongoing phase III development of latarcibart in von Willebrand disease. To close, we are pleased with our performance for the quarter and for the first half of the year and remain confident in our outlook. With that, I'll turn the call back over to the operator for Q&A.

Operator

Thank you. We'll now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. As a reminder, we ask you please ask one question and then return to the queue. Our first question today is coming from Marc Frahm from TD Cowen. Your line is now live.

Marc Frahm

Hi. Thanks for taking my questions. Congrats on the strong quarter commercially. Maybe this is mostly for Pablo. Just on the kind of CALR program and your regulatory discussions, can you maybe just review what the major questions are still kind of awaiting resolution on that trial design in MF?

Marc Frahm

How much of that is the endpoint, whether you can include something like anemia and some sort of composite versus how much of that is still outstanding dose selection work for particularly the type 2s and might on that latter part that take a little bit longer for type 1s versus type 2s and lead to kind of different trial initiation timelines?

Pablo Cagnoni

Good morning, Marc. Thank you for the question. When we think about the regulatory path in MF, there's basically two paths, right? One would be the standard, which I think we all know about, which would include SVR35 and TSS50 as endpoints, or an alternative one, which will include other endpoints. Let me spend a minute on why we think the second is important to discuss with the FDA.

Pablo Cagnoni

We thought and still think it's important to discuss with FDA. INCA033989 is a completely novel mechanism of action, as we all know. On top of delivering benefit, as we saw in the EHA data update that we provided, on top of delivering benefit on SVR35 and TSS50, it delivers an extraordinary benefit on improving hemoglobin levels in these patients.

Pablo Cagnoni

Most of the patients treated, whether it is first or second-line MF, show increases in hemoglobin that are clinically significant. In addition to that, there's clear evidence of what we discussed as disease-modifying evidence, including reduction of malignant megakaryocytes in bone marrow, reduction of malignant progenitors in peripheral blood, et cetera.

Pablo Cagnoni

When you put all that together, we thought and still believe it's important to have a constructive dialogue with the FDA to see how we can incorporate some of these endpoints that reflect the benefit patients receive from INCA033989 and that reflect the mechanism of action of INCA033989, that they need to be reflected in the clinical trial design. We have initiated those conversations with the FDA. They're going well. They're being constructive.

Pablo Cagnoni

As soon as we complete those, we will give you clarity on what the regulatory path will be, first in second-line MF, which we intend to start this year. Then as a result of that, we'll continue the conversation with the agency on first-line MF, which we will initiate next year.

Pablo Cagnoni

At this point, our intention is to conduct a study in MF in all comers, type 1 and non-type 1 patients, potentially with a differential dosing strategy, not quite like ET, because ET we have a dose escalation. The rapid normalization of play of the ET allows you for a rapid dose escalation. In MF, we would start type 1 and non-type 1 patients at two different dose levels instead of doing the dose escalation. That's where we are today with the planning of the study.

Bill Meury

Thanks for the question, Marc.

Operator

Thank you. Our next question today is coming from Eric Schmidt from Cantor Fitzgerald. Your line is now live.

Eric Schmidt

Thank you. Maybe a higher-level strategic question for Bill and team. Given you touched just on the Vega acquisition, how are you feeling about the breadth and depth of your pipeline? Do you have more capacity, and is there some sort of a target R&D as a percentage of sales level that you might want to be spending at as we go into the Jakafi expiration? Thanks.

Bill Meury

Yeah, it's a good question, Eric. A couple of things. As it relates to business development, and frankly, R&D, our job is to keep this product line and pipeline moving. I think you can never underestimate attrition in any business. We are actively looking at potential opportunities that meet or check the same criteria that Vega did. I think that we have a very clear framework for doing business development. When we see opportunities that meet certain strategic and financial criteria, we can act quickly. Alternatively, or on the other hand, we're not solving right now for a fixed margin percentage.

Bill Meury

What I will tell you is if there's any margin compression in this business, let's say, as we get to 2029, there'll have to be a clear and positive correlation with materially increasing the risk-adjusted value of our pipeline. Right now, every line item in our P&L is either absorbing, offsetting, or directly funding the growth strategy.

Bill Meury

As you know, in SG&A, we're funding product launches. As it relates to R&D, 80% of our investment is concentrated on what we think are really smart investments. If any of the investments that we're making, if the facts and circumstances around those investments change or performance is not what we are expected, we stop making those investments.

Bill Meury

As we get closer and we have more clarity on our pipeline, where I think we're set up very well right now, I think when you look at the pipeline, there's four assets that have a high PTRS and the potential to deliver outsized returns.

Bill Meury

That's povorcitinib, INCA033989, G12D, and VGA039. Now, that's not to say that there's not value in TGF-β by PD-1 or CDK2, but the four assets I just mentioned have the potential to move Incyte way beyond Jakafi, which is ultimately what we're solving for. To wrap it up, 12 months of margin compression to set up 10 years of revenue and earnings growth, I think is a smart calculation. That's what we look at every day.

Operator

Thank you. Our next question is coming from Tazeen Ahmad from Bank of America. Your line is now live.

Tazeen Ahmad

Hi, good morning. Thanks for taking my question. I wanted to maybe ask one quick one about the announcement you made last week about your global collaboration with Halozyme to use their enhanced drug delivery technology to help with INCA033989. Can you maybe give us a little bit more color on what exactly you'd like to improve and when you think this could move into clinic and we could start to see data using this technology? Thanks.

Bill Meury

Thanks, Tazeen. Pablo, why don't you set up where we are with the program overall and then get into Halozyme?

Pablo Cagnoni

Certainly. Let me remind you a couple of points that we made, which are really important about this program and the subQ development. We have completed healthy volunteer work. We are right now with the existing subQ formulation in patients with MPNs. That's the status of the program. We have a clear path here to continue that program forward and by optimizing the existing formulation and the existing subcutaneous device for infusion, which is not a wearable, as we discussed before.

Pablo Cagnoni

This is something that patients will have to apply for 15-20 minutes every other week to deliver the desired dose. That path is clear. We have discussions with FDA on a bridging strategy for that path that I just described. We thought it was important to continue to add optionality to this program.

Pablo Cagnoni

As you can imagine, the conversations with Halozyme have been going on for quite some time before signature of the agreement. They're not related in any way to any data that has emerged from the ongoing subcutaneous development.

Pablo Cagnoni

We thought it was important to have an additional option to improve flexibility and potentially to improve the patient experience when it comes to subcutaneous formulation administration of INCA033989. That's basically the plan we have in place. We're executing the existing subcu plan with existing formulation. We're adding another option now with the enhanced technology.

Bill Meury

Thanks a lot for the question.

Operator

Thank you. Our next question today is coming from Faisal Khurshid from Jefferies. Your line is now live.

Faisal Khurshid

Hey, guys. Thank you for taking the question. Can you set expectations for the G12D update that you're going to have at ESMO? Can you possibly give us some more perspective on how you think about competitive positioning and how you see your opportunity to differentiate within the class? Thank you.

Bill Meury

Great. Pablo, you want to take the first part of the question?

Pablo Cagnoni

Certainly. Thank you for the question. When we think about our INCB161734, our G12D inhibitor, I think we are convinced we have in our hands a highly selective, highly potent, novel medicine that combines well with existing standard of care, which is in first-time pancreatic cancer is chemotherapy, either FOLFIRINOX or Gem/Nab. In that context, when we think about the development plan, our goal was to accelerate as much as possible development in first-time pancreatic cancer in combination with those two chemotherapy regimens.

Pablo Cagnoni

What we will do at ESMO is provide approximately 50 patients worth of data, half and half with Gem/Nab and FOLFIRINOX, with a fair amount of maturity, showing you where we are on efficacy and safety in that context. We think that's a really important de-risking for the first-time pancreatic cancer strategy that we're pursuing. The phase III study in first-time pancreatic cancer is ongoing.

Pablo Cagnoni

As far as we know, based on public disclosures, we are neck and neck with our competitors. We don't think we're behind, and our team is executing on that as fast as possible. Let me add a little bit more context on the program because I think it's important the breadth of how we're looking at this program in other indications.

Pablo Cagnoni

We're going to present data as well at ESMO of combination in colorectal cancer. We think that is a really important indication for G12D inhibitor. There's two basic ways to do it, is late-line in combination with EGFR inhibitors and in early lines in combination with chemotherapy and EGFR inhibitors. We'll show some of that data as well at the ESMO meeting.

Pablo Cagnoni

When you start thinking about our G12D program, if things go well and the data that we present continues to de-risk the program, you should think about it in a couple of different tumor types and in a couple of different lines of therapy.

Pablo Cagnoni

Specifically, in pancreatic cancer, in first line, in combination with chemotherapy, and potentially in the adjuvant setting as well, and in colorectal cancer, in late line, in combination with EGFR inhibitors, and potentially in earlier lines, in combination with chemotherapy and EGFR inhibitors. We'll talk about it at ESMO. We think the data we're going to present is a significant de-risking event for this program in first-line pancreatic and potentially in colorectal cancer as well. Thank you for the question.

Bill Meury

I would just add to what Pablo said as it relates to competitive positioning. I think it's unlikely that pancreatic cancer becomes a winner-take-all market. You rarely see that in oncology. I think generally speaking, oncologists resist dependence on a single treatment. This is not, I believe, an either/or calculation. Populations are different.

Bill Meury

There's various combination strategies that can be put in place. I think at the end of the day, this will become about sequencing and matching the right drug with the biology. We believe a selective G12D inhibitor will be used first in G12D patients and then a non-selective later, but there again, it's not either/or. What we do know is there's only two companies right now in phase III studies with the first targeted G12D treatment in pancreatic cancer.

Bill Meury

Whether you're first or early, this for Incyte can be a real needle mover. I think when you look at the data that we'll share at ESMO, you'll be reassured about the activity of this compound in terms of response rates as well as durability of response.

Faisal Khurshid

Thank you.

Bill Meury

Thank you for the question.

Operator

Our next question today is coming from Jay Olson from Oppenheimer. Your line is now live.

Jay Olson

Oh, hey. Congrats on all the progress, including closing the Vega deal. Based on everything you've learned, including feedback from KOLs at ISTH, can you comment on the potential for latarcibart to expand beyond VWD? Eventually, do you think latarcibart can be the next Hemlibra? Thank you.

Bill Meury

Jay, thank you for the question. I'm going to turn it over to Dave Gardner and let him make a few comments.

Dave Gardner

Yeah. Thanks, Jay. Yes, we did get very favorable feedback, both from KOLs and importantly from the patient advocacy channel as well at ISTH. A lot of the discussion was around the impressive clinical profile thus far from latarcibart, but a secondary discussion did emerge around the treatment of bleeds and the urgency to use better prophylaxis to prevent bleeds in a broader set of patients. Coming out of ISTH, absolutely, we are emboldened by the feedback that if we deliver on the target product profile, there is potential to deliver a transformative Hemlibra-like opportunity to these patients.

Bill Meury

Jay, if you think about it, there is a hemophilia A-like population in von Willebrand's, that is a sizable pool of patients who are severe frequent bleeders. If 039 comes out of phase III, like David said, with a substantial reduction in the annual bleed rate and a good benefit-risk profile, adoption in that group, which could be almost 10,000 people, would turn this into one of the largest products Incyte would have.

Bill Meury

The most important thing for us to do right now is execute this phase III program, maintain the quality of the data, then of course, get it approved. All of the substrate is there for this to be a large product. Thanks for the question.

Operator

Thank you. Our next question today is coming from Derek Archila from Wells Fargo. Your line is now live.

Derek Archila

Good morning, thanks for the update, thanks for taking my question. Given Niktimvo's IPF data, phase III data is going to come from Syndax later this year. I know you guys have an opt-in, just wondering if you could walk us through kind of the decision framework, what sort of data threshold may trigger an opt-in, how you communicate that decision, and just remind us of the split on the development cost if you decide to proceed. Thanks.

Bill Meury

Great. Thanks for the question. Pablo?

Pablo Cagnoni

Yes. Derek, good morning, and thank you for the question. The disclosure of the data, since they're conducting the study, will be done by Syndax. It will not be done by us. Obviously, they'll share the data with us. We'll discuss the results, and depending how clear they are, it will take a little bit longer or not to make the decision to pursue the indication together with Syndax.

Pablo Cagnoni

When it comes to the existing agreement, it's the same type of agreement we have for other indications, both in sharing development cost and sharing economics, so there's no difference. When it comes to the opt-in, I just want to make clear that if we decide to opt-in, there's nothing to prevent us from doing so. We really look forward to hearing the data from our colleagues at Syndax, but they will be the ones releasing those results.

Bill Meury

Thanks for the question, Derek.

Operator

Thank you. Our next question today is coming from Andy Chen from Wolfe Research. Your line is now live.

Speaker 12

Hi. Thank you so much for taking my question. This is Jason taking it for Andy, I just wanted to ask, how well is the Jakafi XR conversion tracking along your internal metrics so far? Do you know when payer reimbursement might kick in, which specific earnings will this specifically impact the most? Thank you.

Bill Meury

What was the second part of the question?

Speaker 12

Oh.

Bill Meury

Go ahead.

Speaker 12

When payer reimbursement might kick in and which of the earnings coming up will this impact the most? Thank you.

Bill Meury

Great. Thank you. Go ahead, Pablo. I mean, Mohamed, why don't you go ahead and comment on that?

Mohamed Issa

Yeah. Thanks, Bill, and Jason, thanks for the question. Look, like we mentioned earlier this year, we're focused on accelerating XR formulary access because that will serve as the basis for demand growth, and we're well on track to achieve that goal of 50%-70% formulary coverage by the end of the year. To answer your question specifically, when will payer reimbursement kick in?

Mohamed Issa

It has kicked in, and like Bill mentioned in the prepared remarks, several major payers have already moved and put XR on formulary. We've already seen demand start to pick up, and if by the end of the year, let's just say December, we exit the year with XR maybe representing somewhere between 3%-5% of our demand. That'll put us somewhere in that $40 million-$50 million range that Bill mentioned in the prepared remarks.

Mohamed Issa

That puts us well on our way to that 10%-30% conversion before Jakafi LOE. We're very pleased with the access so far. The market access team has done a really nice job of getting us and putting us in a position for demand generation to accelerate later in 2027.

Bill Meury

Thanks, Jason.

Operator

Thank you. Our next question today is coming from Matt Phipps from William Blair. Your line is now live.

Matt Phipps

Good morning. Thanks for taking my question. Nice execution in the quarter. Pablo, you mentioned the totality of the data did not support continued development 058 for the JAK2 V617F indication. Were there other factors as you changed the formulation of things that contributed to this totality of the data? Can you just run us on the timeline for moving that backup program into the clinics and how you're thinking maybe about the internal program versus the Prelude option? Thank you.

Pablo Cagnoni

Certainly. Thank you for the question. I think you captured the key point there. It was not just about bioavailability. It was not just about exposure. We think the new formulation showed promise, we will continue to escalate. When we started to look at the emerging data, what we look at, as you can imagine, is obviously the PK that you just pointed out to, as well as the safety and efficacy that it's emerging from a particular program.

Pablo Cagnoni

We look at that in the context of other programs that we have in-house and that we have been advancing pre-clinically over the last couple of years. When we put all that together, it just made no sense to continue to develop 058. The next generation programs have moved along very, very well. We're really excited about what the data looks like pre-clinically.

Pablo Cagnoni

We will provide an update pre-clinical data later this year, just so you have clarity on what the differences are between this program, this new program, and 058. We're looking to basically file the IND in the relatively near future. I won't give you a precise point in time right now, we'll provide an update later this year when we present the data, but it's reasonably close to an IND filing. On the Prelude agreement, obviously, those programs are managed by Prelude.

Pablo Cagnoni

In terms of updates, they can provide them. The lead is in the clinic, there are other programs that we discussed with them that they are advancing through different stages of pre-clinical development. We will sit down with them and discuss the current data that they have in terms of providing further updates on that should be done by Prelude since they're programs at this point until we opt-in.

Bill Meury

Thanks for the question, Matt.

Operator

Thank you. Our next question today is coming from Evan Seigerman from BMO Capital Markets. Your line is now live.

Evan Seigerman

Hi, guys. Thank you so much for taking my question. I want to touch back on some of the data at ESMO, specifically on INCB161734. As you prepare to present the PDAC and CRC data later this year, what benchmarks should we use to judge success, and how would you frame your conviction in this asset versus the competitive profile that we had talked about earlier on this call? Thank you very much.

Bill Meury

Thanks for the question, Evan. Pablo?

Pablo Cagnoni

Certainly. Thank you for the question, Evan. The way I think about it is as follows. The first thing, we initiated a phase III trial in pancreatic cancer in combination with chemotherapy, as you know, with INCB161734, and we've shown very little data other than ASCO GI last January. We thought it was very important to have an expanded cohort of patients, as I mentioned, about 50 patients, about half and half with each type of chemotherapy, with some maturity in order to de-risk this program and generate more conviction around that first-line indication.

Pablo Cagnoni

We look at benchmarks, there's two sets of benchmarks here. One is existing chemotherapy, and that's pretty clear. There's a number of publications with response rate in the 30%, 40%, 45%. There are our competitors, which have presented some data as well in combination with chemotherapy.

Pablo Cagnoni

As we put the data at ESMO, we'll discuss it in more detail, We think potentially we have a best-in-class agent here in combination with chemotherapy in front-line pancreatic cancer. We'll discuss those results and hopefully you'll share our level of conviction around that program.

Pablo Cagnoni

When it comes to colorectal cancer, obviously, that's a smaller data set, we'll have data in combination with Erbitux that we also think potentially starts to show signs of being a best-in-class agent to combine with an EGFR inhibitor in patients with colorectal cancer, which we think it might be an underappreciated opportunity for a G12D inhibitor that we intend to pursue.

Bill Meury

Thanks for the question, Evan.

Operator

Thank you. Our next question today is coming from Michael Schmidt from Guggenheim. Your line is now live.

Michael Schmidt

Hey, guys. Thanks for taking my questions. I had one on the PD-1 TGF-β asset 890. Pablo, I guess, what is your level of conviction that this could succeed in frontline colorectal cancer? How is that positioned longer term in the CRC space relative to other emerging therapies, including amivantamab or ivonescimab, which are in phase III? Then how do you think about other opportunities for this agent longer term?

Pablo Cagnoni

Thank you for the question, Michael. Okay, let's start with frontline colorectal cancer. What we know today is that TGFβR2 by PD-1 antibody generated what I would describe as the best single-agent activity ever reported for a PD-1 therapy in patients with MSI colorectal, particularly in patients with liver metastasis. That led to an acceleration of that program.

Pablo Cagnoni

We generated data in combination with FOLFOX/bev that first showed it was tolerable and they show increasingly a level of responses and durability that convinced us that was the right path forward. What we're going to show at ESMO is a pretty large data set with a fair amount of follow-up that we believe supports the frontline strategy with FOLFOX/bev. We're fully aware of the competitive landscape.

Pablo Cagnoni

I think the difference here, both approaches might work, Michael, I think the difference is bevacizumab is a very important drug in patients with colorectal cancer. When you give a PD-1 by VEGF, you cannot give full dose bev. By giving a TGFβR2 by PD-1, we can give the full dose bevacizumab, which we believe could potentially be a differentiating feature. Data over time will decide which one of those approaches is better, and both might be successful.

Pablo Cagnoni

That's point numbe one. The second is we've generated data also in combination with bevacizumab alone. Some of the data might be presented at the meeting as well, and we believe also continues to show the potential of TGF-beta receptor by PD-1 in colorectal cancer more broadly. When it comes to other tumor types, as you know, we've done some work in other tumor types.

Pablo Cagnoni

I'm not sure we're going to have time for an update on that at ESMO. We want to focus at ESMO on the three things that I discussed in my prepared remarks. G12D in pancreatic and colorectal, TGF-β by PD-1 in colorectal, and INCB123667 in patients with ovarian cancer now in combination with bevacizumab, which we also think it's an important update de-risking the maintenance study that we're conducting in that program.

Bill Meury

Thanks, Michael.

Operator

Thank you. Our next question today is coming from Jessica Fye from JPMorgan. Your line is now live.

Jessica Fye

Hey, guys. Good morning. Thanks for taking my questions. Just wanted to confirm what the right way to think about Opzelura gross to nets is going forward. Also, can you just remind me of your regulatory plans for povorcitinib in vitiligo? Thank you.

Bill Meury

Great, Jess. I'll take the first part of the question and Mohamed or Suky can add. In simple terms, we were working with a gross to net in the low 60s. With the settlement, now we're in the high 50s. As I had mentioned at the start of the call, it just simply improves the gross to net profile and average selling price for Opzelura. We made a strategic decision at the beginning of the year to expand access. There was an investment associated with that.

Bill Meury

I can tell you, here we are seven months later, I think it was the right decision because when you look at the fundamentals of this business, which is basically volume growth coupled with coverage, we're in a really good spot. Our job right now is to just manage this selling price as we get into 2027 and 2028. I think that pretty much covers it, I think I can turn it over to Pablo or Steven to talk about the vitiligo regulatory plan.

Pablo Cagnoni

Thank you for the question, Jess. The plan in vitiligo, after discussions we had with FDA over the past year or so, is to submit right after the approval in HS with two years of safety data, safety follow-up in the vitiligo patients. Basically, the team is preparing the filing. As soon as we get the HS and we sort of collect the two-year follow-up, we will submit that. It's going to go in early next year.

Bill Meury

Thanks, Jess.

Operator

Thank you. Our next question today is coming from Salveen Richter from Goldman Sachs. Your line is now live.

Salveen Richter

Thank you. Good morning. Could you speak to your target profile for the mutCALR program-INCA033989 as we look to first-line data by year-end in both the mono and combo cohorts, versus what you've established with Jakafi and the traditional endpoints of spleen and symptoms? Maybe put this in the context of the composite endpoint that you're trying to create as well. Thank you.

Bill Meury

Great. Thanks for the question.

Pablo Cagnoni

Thank you, Salveen. As I mentioned, I won't repeat myself, early in the call, there's two regulatory paths here. One, traditional endpoints, as you allude, with SVR35 and TSS50, and the conversations we're having with FDA on second-line MF. Depending on the success of those conversations, some of those lessons may be applied to first-line MF or not.

Pablo Cagnoni

Our conviction here remains because of the data we presented in a small subset of JAK-ineligible patients, which is basically a JAK-naive population, which we present at EHA, and we will update later this year. We show pretty solid numbers in terms of SVR35 and TSS50, stronger in type 1 patients than non-type 1. Certainly, when you think about, if you remember the EHA data, there were very few non-type 1 patients that received a higher dose. We do know those patients do need a higher dose.

Pablo Cagnoni

When you put all that together, our conversations with FDA will complete the second-line MF conversations. Depending on that, and whether we are able to advance a different endpoint or not, we will decide the regulatory path for first-line MF. As of today, our plan continues to be in first-line MF to develop INCA033989, both as a single agent and in combination with Jakafi, and both in type 1 and non-type 1 patients. That's still the plan.

Bill Meury

Thanks, Salveen.

Operator

Thank you. Our final question today is coming from Mitchell Kapoor from H.C. Wainwright. Your line is now live.

Speaker 19

Hi, this is Mirav for Mitchell. Thank you for taking our question. I guess in the same vein, could you help set the stage for the 2H 2026 treatment-naive MF readout? What would support advancing INCA033989 monotherapy versus plus ruxolitinib or both? How are you viewing the analysis of the incremental contribution of INCA033989 in the combination arm?

Bill Meury

Mitchell, could you just repeat the question? Your audio broke up.

Speaker 19

Oh, yeah, no problem. I was just asking if you could help set the stage for the treatment-naive MF readout. What would help support the decision to advance INCA033989 monotherapy versus in combination?

Pablo Cagnoni

Oh, terrific. Thank you. Look, we have the JAK-ineligible cohort from EHA. That's the first data set that we have, which is about 20 patients that showed what I would describe as strong SVR35 and TSS50 data. As I mentioned to Salveen, maybe we needed more data at the higher doses in non-type 1 patients to sort of complete the picture. Later this year, we'll have between 50 and 60 patients worth of data with long follow-up, both in combination with Jakafi and as a single agent.

Pablo Cagnoni

That's a small randomized cohort. I think all that data put together is what's going to determine which path we go forward. Based on the emerging data that we have, our plan today is to develop INCA033989 in front line, both single agent and in combination, both in type 1, non-type 1 patients. Obviously, the data that we're generating as we speak, and that we'll provide an update on later this year, will make the final determination there.

Bill Meury

Thanks for the question, Mitchell.

Operator

Thank you. That does conclude our question and answer session. Ladies and gentlemen, that does conclude today's teleconference and webcast. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.

As of 2026-09-05 • Updated weeklySource: Earnings sourceIngestion runbook