Nilotinib Hydrochloride

Total revenue of $1.67 billion and total net sales of $1.49 billion in the second quarter of 2026, an increase of 38% and 40%, respectively, compared to the second quarter of 2025 Total net sales, excluding the one-time, non-cash benefit for Opzelura® (ruxolitinib) cream related to the CMS settlement,* grew 17% compared to the prior year period Jakafi®/Jakafi XR™ (ruxolitinib) net sales of $817 million , an increase of 7% compared to the same period in 2025 Opzelura net sales of $450 million , an increase of 173% versus the prior year period; excluding the one-time, non-cash benefit,* Opzelura net sales were $204 million , an increase of 24% versus the prior year period Hematology and Oncology portfolio net sales of $222 million , an increase of 69%, compared to the second quarter of 2025 Updating 2026 full year financial guidance for total net sales and operating expenses Ten clinical data readouts, including data from four registrational trials, expected throughout the second half of 2026 Conference Call and Webcast Scheduled Today at 8:00 a.m. ET WILMINGTON, Del. --(BUSINESS WIRE)--Jul. 28, 2026-- Incyte (Nasdaq:INCY) today reported financial results for the second quarter of 2026 and provided a business update. “Our second quarter was marked by broad-based sales growth, continued pipeline progress and strategic business development,” said Bill Meury , Chief Executive Officer, Incyte . “Every marketed product contributed to growth, reflecting the strength of our commercial portfolio and execution. We also recently strengthened our Hematology franchise through the acquisition of latarcibart, a potentially transformative medicine for von Willebrand disease currently in Phase 3 development. With ten data readouts expected in the second half of 2026, alongside product launches through early next year, we are well positioned for our next phase of growth.” Second Quarter 2026 Results Opzelura Financial Impact Related to Agreement with CMS As a result of the agreement with CMS,* the total estimated incremental impact on Opzelura net sales for the full year 2026 is $300 - $310 million which includes the reversal of previously established accrual balances through the first quarter of 2026 and effects of an improved gross-to-net (GTN) profile on a go-forward basis as summarized in the table below. 2026 Financial Guidance Incyte is raising its full year 2026 total net sales guidance to $5,130 - $5,260 million , reflecting the impact of the agreement with CMS related to the Opzelura line extension,* as well as the continued strong performance of its Hematology and Oncology growth products, including Niktimvo, Monjuvi/Minjuvi and Zynyz. Incyte is raising its full year 2026 Opzelura net sales guidance to $1,050 - $1,100 million and full year 2026 Hematology and Oncology net sales guidance to $860 - $890 million . Incyte is also raising its full year 2026 operating expense guidance. Total GAAP R&D and SG&A operating expense guidance is $4,915 - $4,995 million and total non-GAAP R&D and SG&A operating expense guidance is $4,625 - $4,695 million . The revised guidance reflects the impact of the acquisition of Vega Therapeutics, including an IPR&D expense of approximately $1,270 million expected in the third quarter 2026 associated with the upfront payment and related transaction costs, as well as $50 million of incremental ongoing R&D investments related to the development of latarcibart. The transaction upfront payment is expected to result in an IPR&D expense reflected in the third quarter and full year 2026 GAAP and non-GAAP financial results. Incyte’s guidance for the fiscal year 2026 is summarized below. Key Business Updates Hematology Jakafi XR™ (ruxolitinib) Monjuvi/Minjuvi Niktimvo INCA033989 (mutCALR) INCB160058 (JAK2V617F) Latarcibart (formerly VGA039) Oncology INCB161734 (KRASG12D) INCA33890 (TGFβR2xPD-1)† INCB123667 (CDK2) Inflammation and Autoimmunity (IAI) Opzelura Povorcitinib Corporate Updates 2026 Second Quarter Financial Results The financial measures presented in this press release for the three and six months ended June 30, 2026 and 2025 have been prepared by the Company in accordance with U.S . Generally Accepted Accounting Principles (“GAAP”), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry. As changes in exchange rates are an important factor in understanding period-to-period comparisons, management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand the Company’s operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP. Financial Highlights Revenue Details Net Sales and Royalty Revenues Total net sales and royalty revenue for the quarter ended June 30, 2026 increased 37% over the prior year comparative period. Operating Expenses Cost of sales GAAP and Non-GAAP cost of sales for the quarter ended June 30, 2026 were $105.0 million and $98.6 million , respectively, representing 7% of total net sales. Contract dispute settlement In May 2025 , Incyte and Novartis entered into a settlement agreement with respect to litigation relating to the duration of royalty payments owed under the Collaboration and License Agreement between Incyte and Novartis. Under the settlement agreement, the royalty rate payable by Incyte on future net sales of Jakafi in the United Stated is reduced by 50% beginning January 1, 2025 and Incyte paid Novartis $280.0 million as the settlement of disputed royalties on net sales of Jakafi in the United States through December 31, 2024 . The difference of $242.2 million between the accrued royalties and the total amount paid by us to Novartis was recorded in contract dispute settlement on the condensed consolidated statement of operations for the three and six months ended June 30, 2025 . Research and development expenses GAAP and Non-GAAP research and development expenses for the quarter ended June 30, 2026 were $517.0 million and $478.8 million , an increase of 4% and 5%, respectively, compared to the same period in 2025, primarily due to continued investment in our late stage development assets. Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended June 30, 2026 were $351.7 million and $323.6 million , an increase of 6% for each, respectively, compared to the same period in 2025, primarily due to increased consumer marketing and pre-launch activities. Other Financial Information Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended June 30, 2026 , compared to the same period in 2025, was primarily due to updated projections of future net sales of Iclusig, including the impacts from fluctuations in foreign currency exchange rates. Operating income GAAP and Non-GAAP operating income for the quarter ended June 30, 2026 increased 32% and 102%, respectively, compared to the same period in 2025, driven primarily by growth in total revenue, including the impact of the $246 million of additional net sales of Opzelura relating to the aforementioned CMS agreement, and the impacts of the contract dispute settlement in the second quarter of 2025 on Non-GAAP operating income. Cash, cash equivalents and marketable securities position Cash, cash equivalents and marketable securities as of June 30, 2026 , were $4.5 billion , compared to $3.6 billion as of December 31, 2025 . Conference Call and Webcast Information Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET . To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13759527. If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13759527. The conference call will also be webcast live and can be accessed at investor.incyte.com. About Incyte ® Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation and Autoimmunity. To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram. Incyte is a registered trademark of Incyte . About Jakafi® (ruxolitinib) Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved for use in the U.S . for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to, or are intolerant of, hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-PV MF and post-essential thrombocythemia MF in adults; steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Jakafi is a registered trademark of Incyte . About Jakafi XR™ (ruxolitinib) Extended-Release Tablets Jakafi XR™ (ruxolitinib) extended-release tablets are a once-daily (QD) formulation of ruxolitinib, approved for use in the U.S . for the treatment of PV in adults who have had an inadequate response to, or are intolerant of, hydroxyurea; intermediate or high-risk MF, including primary MF, post-PV MF, and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. It is not known if Jakafi XR is safe or effective in children for the treatment of MF or PV. Jakafi XR and the Jakafi XR logo are trademarks of Incyte . About Opzelura® (ruxolitinib) Cream Opzelura® (ruxolitinib) cream, a novel cream formulation of Incyte’s JAK1/JAK2 inhibitor ruxolitinib, is the first and only treatment for repigmentation approved for use in the U.S . for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older. Opzelura also is approved for use in the U.S . for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In Europe , Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of nonsegmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Incyte has worldwide rights for the development and commercialization of Opzelura. Opzelura is a registered trademark of Incyte . About Monjuvi® (tafasitamab-cxix)/Minjuvi® (tafasitamab) Monjuvi® (tafasitamab-cxix)/Minjuvi® (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. In the U.S ., Monjuvi is approved for use in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. Additionally, Monjuvi received approval in the U.S . in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In Europe , Minjuvi (tafasitamab) received conditional marketing authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Additionally, Minjuvi is approved for use in Europe in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy. In Japan , Minjuvi is approved for use in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory FL (2L+ FL). XmAb is a registered trademark of Xencor, Inc. Monjuvi and Minjuvi are registered trademarks of Incyte . About Pemazyre® (pemigatinib) Pemazyre® (pemigatinib) is a kinase inhibitor approved for use in the U.S . for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA -approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in one or more confirmatory trials. Pemazyre is also the first targeted treatment approved for use in the U.S . for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. In Japan , Pemazyre is approved for use for the treatment of patients with unresectable biliary tract cancer (BTC) with an FGFR2 fusion gene that worsens after cancer chemotherapy. In Europe , Pemazyre is approved for use for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that has progressed after at least one prior line of systemic therapy. Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 that has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Pemazyre is marketed by Incyte in the United States , Europe and Japan . Pemazyre is a trademark of Incyte . About Iclusig® (ponatinib) tablets Iclusig® (ponatinib) targets not only native BCR-ABL, an abnormal, fused gene and protein associated with several types of leukemia, most notably Chronic Myeloid Leukemia (CML) and Philadelphia -positive Acute Lymphoblastic Leukemia (Ph+ ALL), but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved tyrosine kinase inhibitors. In Europe , Iclusig is approved for use for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia -chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland , the UK , Norway , Turkey , Israel and Russia . Iclusig is marketed in the U.S . by Millennium Pharmaceuticals, Inc. , a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. About Zynyz® (retifanlimab-dlwr) Zynyz® (retifanlimab-dlwr) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), approved for use in the U.S ., Europe and Japan in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and in the U.S . as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy. Zynyz is also approved for use as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S ., Europe , Canada and Switzerland . Incyte licenses exclusive worldwide rights to develop and commercialize Zynyz from MacroGenics, Inc. Zynyz is a registered trademark of Incyte . About Niktimvo™ (axatilimab-csfr) Niktimvo™ (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). In September 2021, Syndax Pharmaceuticals, Inc. and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications. Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256). Niktimvo is a trademark of Incyte. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Incyte’s expected financial and operational performance; Incyte’s updated 2026 full year financial guidance; expectations regarding the impact of Incyte’s agreement with CMS pertaining to Opzelura; Incyte’s ability to deliver sustained long-term growth; the strength of Incyte’s core business and marketed products; the potential and progress of programs in Incyte’s pipeline; expectations regarding clinical trials to be initiated, ongoing clinical trials and anticipated data readouts, including for Niktimvo (axatilimab), INCA033989 (mutCALR), latarcibart, INCB161734 (KRASG12D), INCA33890 (TGFβR2xPD-1), INCB123667 (CDK2), Opzelura (ruxolitinib) cream and povorcitinib; expectations regarding regulatory submissions, regulatory approvals and launches, including for Monjuvi in newly diagnosed DLBCL and Opzelura in moderate atopic dermatitis in Europe; expectations regarding Incyte’s partnerships and collaborations; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; the efficacy or safety of Incyte’s products; Incyte’s ability to achieve commercial success for its marketed products and product candidates, if approved; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; greater than expected expenses, including expenses relating to litigation or strategic activities; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte’s products; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements. View source version on businesswire.com: https://www.businesswire.com/news/home/20260728733422/en/ Media media@incyte.com Investors ir@incyte.com Source: Incyte

Novartis is undergoing one of the most significant portfolio challenges in its history, with loss of exclusivities affecting several of its key assets. Credit: Michael Derrer Fuchs/Shutterstock.com. Despite a lacklustre start to the year, Novartis seems to have overcome its financial slump, reporting operating profits in Q2 that exceeded analyst expectations. The Swiss drugmaker’s core operating income for the quarter was $5.94bn, representing flat year-over-year growth. However, this was ahead of analyst expectations of $5.31bn via Visible Alpha. Quarterly sales grew 1% at constant currency to $14.1bn, which was a 3% beat on expectations as per a research note from Citi analysts. Novartis is undergoing one of the most significant portfolio challenges in its history, with loss of exclusivities affecting several of its key assets. The most important in this group is blockbuster heart failure medication Entresto (sacubitril/valsartan). The drug racked up $7.8bn in peak sales in 2025, though revenue has been plummeting since the core US patent expired last year. That led to a weak Q1 for the company , with profits down 12%. Entresto sales dropped 42% in Q1, and the story has continued into Q2 with the medicine’s sales declining 50%. Other drugs are also suffering from generics market entry, including blood disorder medicine Promacta (eltrombopag) and blood cancer therapy Tasigna (nilotinib). However, in positive momentum for Novartis, new medicines growth meant the drugmaker has stemmed the tide in Q2. Breast cancer drug Kisqali (ribociclib) continued to do much of the heavy lifting, growing 43% compared to the same quarter last year to $1.7bn. Kesimpta (ofatumumab), a multiple sclerosis drug, generated $1.4bn, an increase of 32%. Oncology assets Scemblix (asciminib) and Pluvicto also contributed as growth drivers, alongside cholesterol-lowering injection Leqvio (inclisiran). Scemblix was the highest-growth medication amongst Novartis’ priority brands, up 89% from last year’s same quarter due to strong momentum among newly diagnosed chronic myeloid leukaemia patients. Looking ahead, Novartis reaffirmed its 2026 guidance of low single-digit growth for net sales. Core operating income is expected to decline low single-digit. The company has key trial readouts and new launches to lean on. Chief among these is Bruton’s tyrosine kinase (BTK) inhibitor Rhapsido (remibrutinib). The drug has been racking up regulatory wins over the past year in chronic spontaneous urticaria (CSU), a significant market opportunity. Citi analysts already highlighted a “solid CSU launch, with strong early US uptake” for the drug, which is also approved for the skin disorder in Europe. Novartis CEO Vas Narasimhan said: “Novartis delivered a solid second quarter, returning to sales growth driven by continued momentum from Kisqali, Kesimpta, Scemblix and Pluvicto. We are encouraged by the early trajectory of our recent launches, Rhapsido in CSU and Itvisma. We also made meaningful pipeline progress, highlighted by updated Kisqali overall survival data in early breast cancer and the FDA accelerated approval submission for del-zota in DMD. We are on track for multiple important readouts ahead in the second half and remain on track to deliver our full-year guidance and mid-term outlook.”