Latest news with #Jakafi
Daily Mail
28-05-2025
- General
- Daily Mail
Doctors sound alarm over anti-inflammatory drugs taken by millions that leave you open to deadly viral infections
Drugs were designed to banish discomfort and disease. But a new study has revealed that a class of common anti-inflammatory drugs may actually make people sicker. Researchers from the Norwegian University of Science and Technology (NTNU) discovered that a class of medications called Janus kinase (JAK) inhibitors can make the body vulnerable to viral infections. The medications work by blocking immune system proteins in the body that often lead to inflammation and pain. They are used to treat of a variety medical conditions suffered by millions globally, including rheumatoid arthritis, eczema, alopecia, and certain bone cancers. They are relatively new drugs, and the first JAK inhibitor, sold under the brand name Jakafi for cancer treatment, was only just approved by the FDA in 2011. However, there is now evidence suggesting these drugs - which are typically taken as pills - could help the flu, Covid-19 and other viruses infiltrate the body's immune system, potentially leading to severe infection. The scientists say this is because the drugs 'suppress an important immune signaling pathway that helps protect healthy cells from viral attacks.' The scientists found drugs in the class, such as baricitinib, which is sold under the brand name Olumiant for the treatment of alopecia - slow down the genes that respond to viruses. 'These genes play a crucial role in the body's response to viral infections,' said Aleksandr Ianevski, an NTNU researcher and co-author of the new paper. By stopping or slowing down this pathway, JAK inhibitors remove the body's 'antiviral shield'. This allows viruses to more easily gain a foothold in the body and spread. The researchers used advanced techniques in a lab to look at how JAK inhibitors impact organs and how viruses attack the body once they have been exposed. They examined cells from the lungs, eyes and brain, as well as laboratory-created mini-organs. Off the back of their findings Erlend Ravlo, a PhD research fellow at NTNU, said: 'Although JAK inhibitors are effective in the treatment of inflammation, this shows that they can pose a hidden risk for patients who have latent or active viral infections.' The findings suggest healthcare professionals should be cautious when prescribing JAK inhibitors, especially during viral outbreaks. Common side effects of the medications include headaches, nausea, fatigue, diarrhea, acne, and elevated cholesterol. Meanwhile, rarer but more serious side effects include severe infections like pneumonia or shingles, damage to the stomach or intestines, and changes in blood cell counts. While the immunosuppressive effects of the drugs could be harmful, the researchers point out that it could be useful in controlled environments, such as in the development of vaccines or screening of antiviral drugs. 'We recommend further studies to better understand how the drugs can be used optimally, especially during virus outbreaks or pandemics,' says Ianevski. The researchers hope to increase awareness among doctors and researchers about the effects of these drugs to prevent patients from developing new illnesses. This is especially important for vulnerable patients, such as the elderly or individuals with chronic illnesses or disabilities. The findings were published in the medical journal, NAR Molecular Medicine.
Yahoo
13-05-2025
- Business
- Yahoo
INCY Q1 Earnings Call: New Product Launches and Pipeline Progress Drive Outperformance
Biopharmaceutical company Incyte Corporation (NASDAQ:INCY) reported Q1 CY2025 results exceeding the market's revenue expectations , with sales up 19.5% year on year to $1.05 billion. Its non-GAAP profit of $1.16 per share was 10.6% above analysts' consensus estimates. Is now the time to buy INCY? Find out in our full research report (it's free). Revenue: $1.05 billion vs analyst estimates of $989.2 million (19.5% year-on-year growth, 6.4% beat) Adjusted EPS: $1.16 vs analyst estimates of $1.05 (10.6% beat) Adjusted EBITDA: $227.5 million vs analyst estimates of $279.3 million (21.6% margin, 18.5% miss) Operating Margin: 19.5%, up from 10.4% in the same quarter last year Free Cash Flow Margin: 27.9%, up from 23.8% in the same quarter last year Market Capitalization: $11.78 billion Incyte's first quarter results reflected notable commercial momentum and pipeline advancement, with management attributing much of the company's performance to strong demand for Jakafi and the initial launch of Niktimvo. CEO Herve Hoppenot highlighted the successful rollout of Niktimvo in chronic graft-versus-host disease, as well as ongoing growth in Jakafi's polycythemia vera indication. Management also emphasized the positive impact of expanded formulary coverage for Opzelura, now preferred on two of the three largest pharmacy benefit manager formularies, resulting in broader patient access and higher net product revenue. Looking ahead, Incyte's leadership outlined several key revenue drivers. Hoppenot pointed to three additional planned product launches in 2025, continued progress in late-stage clinical studies, and several pivotal data readouts as critical to sustaining growth. CFO Christiana Stamoulis reaffirmed increased full-year guidance for Jakafi, citing favorable gross-to-net dynamics and persistent patient demand. Management also addressed tariff concerns, stating that dual US and European manufacturing provides flexibility, minimizing potential impacts from trade policy changes. Incyte's management detailed a quarter shaped by strong product demand, expanding market access, and pipeline milestones. Key topics included new product launches, growth in core franchises, and the impact of healthcare policy changes. Jakafi growth in polycythemia vera: Management cited robust volume increases for Jakafi, especially in the polycythemia vera indication, supported by early intervention data and effective physician education campaigns. They expect polycythemia vera to become the largest driver for Jakafi over time. Opzelura's expanded access: The addition of Opzelura to Optum Premium's preferred formulary improved its commercial coverage to 94%, enhancing growth prospects for both atopic dermatitis and vitiligo indications. Niktimvo launch momentum: The launch of Niktimvo for chronic graft-versus-host disease exceeded initial expectations, with rapid uptake across leading bone marrow transplant centers. Management noted that 95% of top centers have used the product. Pipeline data readouts: Positive phase 2 and phase 3 clinical data for pipeline assets such as povorcitinib in hidradenitis suppurativa and chronic spontaneous urticaria were highlighted, with management aiming for three additional product launches in 2025. Tariff risk mitigation: Management explained that dual sourcing and geographically diversified manufacturing reduce the impact of potential pharmaceutical tariffs, while inventory levels for at-risk inputs remain sufficient to support near-term supply needs. Management's outlook for the next several quarters focuses on continued product launches, new clinical data, and operational efficiency as the main themes underpinning future performance. Multiple product launches ahead: The company expects three more launches in 2025, which management believes will materially expand the commercial portfolio and near-term revenue base. Advancing pipeline milestones: Several late-stage and pivotal clinical trials are on track for readouts this year, including phase 3 studies in dermatology and oncology, which could broaden Incyte's approved indications and market reach. Operational flexibility and risk management: Diversified manufacturing and inventory strategies are expected to safeguard supply continuity, while management cited ongoing investments in R&D and commercial infrastructure as essential for long-term growth. Michael Schmidt (Guggenheim): Asked how much Jakafi's polycythemia vera growth is driven by new patient starts versus ongoing therapy; management noted both contribute, with new patient education and persistence supporting future expansion. David Lebowitz (Citi): Inquired about povorcitinib's positioning in chronic spontaneous urticaria relative to biologics; management responded it could serve both pre- and post-biologic patient populations, with some preferring an oral option first. Salveen Richter (Goldman Sachs): Sought details on Opzelura's growth by indication and steps to improve access for atopic dermatitis; management described stable growth across both indications and ongoing efforts to expand formulary coverage and patient support services. Jessica Fye (JPMorgan): Asked about capital allocation and the potential for further share repurchases; management emphasized prioritizing pipeline investment, with business development focused on early-stage partnerships. Madeline (William Blair): Queried whether positive phase 2 data in chronic spontaneous urticaria alters Incyte's plans for other related programs; management noted satisfaction with current pipeline progress, with no plans to restart previously discontinued programs. In the coming quarters, the StockStory team will be monitoring (1) the pace and breadth of new product launches and their initial market adoption, (2) the timing and outcome of late-stage clinical data readouts, particularly in dermatology and oncology, and (3) the continued expansion of commercial coverage for Opzelura and other key products. Execution on these initiatives, along with effective supply chain management amid evolving tariff risks, will be critical for tracking Incyte's strategic progress. Incyte currently trades at a forward P/E ratio of 10.3×. Should you load up, cash out, or stay put? The answer lies in our free research report. The market surged in 2024 and reached record highs after Donald Trump's presidential victory in November, but questions about new economic policies are adding much uncertainty for 2025. While the crowd speculates what might happen next, we're homing in on the companies that can succeed regardless of the political or macroeconomic environment. Put yourself in the driver's seat and build a durable portfolio by checking out our Top 6 Stocks for this week. This is a curated list of our High Quality stocks that have generated a market-beating return of 176% over the last five years. Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-small-cap company Comfort Systems (+782% five-year return). Find your next big winner with StockStory today. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Reuters
29-04-2025
- Business
- Reuters
Incyte raises 2025 sales forecast for blood cancer drug after solid quarter
April 29 (Reuters) - Incyte Corp (INCY.O), opens new tab raised its annual sales forecast for its blood cancer treatment Jakafi on Tuesday, after robust sales of the drug helped it beat Wall Street estimates for quarterly results. Apart from higher demand, Incyte attributed the first-quarter sales to policy benefits from the Inflation Reduction Act and less destocking by retailers and distributors. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Sales from Jakafi rose 24% from a year ago to $709 million for the quarter, compared with analysts' estimate of $638.4 million. Jakafi, a treatment for myelofibrosis and polycythemia vera cancers, is also approved for a condition called acute graft-versus-host disease, a condition where the donor's bone marrow or stem cells attack the recipient's body. Incyte now expects annual sales of Jakafi between $2.95 billion and $3 billion, up from prior range of $2.93 billion to$2.98 billion. Analysts expected annual sales of $2.96 billion for the drug, according to data compiled by LSEG. The drugmaker is also banking on its skin disorder drug Opzelura, a treatment for vitiligo and mild-to-moderate atopic dermatitis in patients 12 years and older, to drive growth as it braces for Jakafi to lose key patents in 2028. Although sales from Opzelura rose 38% from a year ago to $119 million for the quarter, they fell short of analysts' estimate of $131.6 million. On an adjusted basis, Incyte earned $1.16 per share in the quarter ended March 31, outperforming analysts' estimate of $1.02 per share. Total revenue for the quarter was $1.05 billion, beating an estimate of $993.1 million.
Business Wire
29-04-2025
- Business
- Business Wire
Incyte Reports 2025 First Quarter Financial Results and Provides Updates on Key Clinical Programs
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today reports 2025 first quarter financial results, and provides a status update on the Company's clinical development portfolio. "The double-digit revenue growth in the first quarter driven by the continued growth of Jakafi and Opzelura and the recent launch of Niktimvo, puts us on track to achieve our full year objectives," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We also continued to advance our innovative pipeline, which will be critical for driving long-term growth. The positive Phase 3 results for povorcitinib in hidradenitis suppurativa in addition to the proof-of-concept in chronic spontaneous urticaria, strengthens the potential of povorcitinib as a multibillion-dollar product addressing patient needs across the five indications currently in development.' Key Commercial Highlights Jakafi ® (ruxolitinib): Net product revenues for the first quarter 2025 of $709 million (+24% Y/Y): Net product revenue growth in the first quarter of 2025 versus the same quarter in the prior year, was driven by an increase in paid demand, the positive impact of the Part D redesign under the Inflation Reduction Act, partially offset by growth in 340B, and less de-stocking compared to the first quarter of 2024. Jakafi inventory levels were within normal range at the end of the first quarter of 2025. Opzelura ® (ruxolitinib) cream: Net product revenues for the first quarter 2025 of $119 million (+38% Y/Y): U.S. net product revenue of $95 million in the first quarter of 2025 increased 20% compared to the first quarter of 2024 driven by patient demand and refills in both atopic dermatitis (AD) and vitiligo, partially offset by a reduction in channel inventory. Opzelura inventory levels were within normal range at the end of the first quarter of 2025. Ex-U.S. net product revenues of $23 million in the first quarter of 2025 were primarily driven by continued growth in sales in Germany and France, as well as the recent launches in Italy and Spain. Pipeline Updates Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights The Phase 1 studies evaluating mutCALR in myelofibrosis (MF) and essential thrombocythemia (ET) and JAK2V617Fi in MF are enrolling patients. Initial proof of concept data for both studies are anticipated in 2025. A Phase 2 trial evaluating axatilimab (Niktimvo ™) in combination with ruxolitinib (Jakafi) in patients with newly diagnosed chronic GVHD is ongoing and enrolling patients. A Phase 3 trial evaluating axatilimab in combination with corticosteroids in patients with newly diagnosed chronic GVHD is ongoing and enrolling patients. Other Hematology/Oncology – key highlights Incyte plans to initiate Phase 3 studies for its potentially first-in-class CDK2 inhibitor (INCB123667), in ovarian cancer in 2025 and is also evaluating INCB123667 in combination with other treatments. The Phase 3 study evaluating tafasitamab as first-line treatment for DLBCL is ongoing. The Phase 3 data are anticipated in the second half of 2025. The Phase 1 studies evaluating KRASG12D and TGFßR2×PD-1 in solid tumors are ongoing and enrolling patients. Initial proof of concept data for both studies are anticipated in the second half of 2025. Inflammation and Autoimmunity (IAI) – key highlights Ruxolitinib Cream In March 2025, results from two Phase 3 studies (TRuE-PN1 and TRuE-PN2) evaluating ruxolitinib cream in patients with prurigo nodularis (PN) were presented in a late-breaking oral session at the American Academy of Dermatology annual meeting. The TRuE-PN1 study met the primary endpoint of a > 4-point improvement from baseline in Worst-Itch Numeric Rating Scale (WI-NRS4) at Week 12 and all key secondary endpoints. The TRuE-PN2 study did not reach statistical significance for the primary endpoint, resulting in the key secondary endpoints with nominal p-values. These key secondary endpoints still demonstrate positive trends for ruxolitinib cream 1.5% versus vehicle. These data will inform planned discussions with regulatory authorities on submission. A Phase 3 trial for ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) is on track to initiate in the first half of 2025 following achieving alignment on the study design with FDA. Povorcitinib (INCB54707) In April 2025, Incyte announced positive topline results from the Phase 2 study evaluating povorcitinib in patients with chronic spontaneous urticaria (CSU). The study met the primary endpoint at Week 12 of change from baseline in the Urticaria Activity Score summed over 7 days (UAS7). Povorcitinib was well tolerated with no new safety signals observed. These data will support planned discussions with regulatory agencies and will be presented at an upcoming medical conference. In March 2025, positive results from the Phase 3 studies (STOP-HS1 and STOP-HS2) of povorcitinib in patients with HS were presented and demonstrated that both studies met their primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 and at both tested doses (45mg and 75mg). In addition, at Week 12, patients treated with povorcitinib achieved deep levels of clinical response with a greater proportion achieving HiSCR75, reduction in flares, >3-point decrease in the Skin Pain Numeric Rating Scale (NRS) score and Skin Pain NRS30. Furthermore, povorcitinib demonstrated rapid onset of response, including rapid skin pain reduction. Additional longer-term data demonstrate that at Week 18, HiSCR rates continue to improve over Week 12 in patients treated with povorcitinib including high levels of response in those patients previously treated on placebo and crossed over to active povorcitinib treatment. These data support the planned regulatory submission of povorcitinib for the treatment of HS worldwide. Two Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with PN versus placebo are ongoing and enrolling patients. A Phase 2 trial evaluating povorcitinib in asthma is ongoing and enrolling. Data are anticipated in the second half of 2025. Other - key highlights In February 2025, Incyte and Genesis Therapeutics, Inc. (Genesis) entered into a strategic collaboration focused on the research, discovery and development of novel small molecule medicines, with an initial focus on collaboration targets selected by Incyte. Incyte receives exclusive rights to develop and commercialize collaboration products leveraged through Genesis' GEMS artificial intelligence (AI) platform. 2025 First Quarter Financial Results The financial measures presented in this press release for the three months ended March 31, 2025 and 2024 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 its 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. Revenue Details Revenue Details (unaudited, in thousands) Three Months Ended March 31, % Change (as reported) % Change (constant currency) 1 2025 2024 Net product revenues: Jakafi $ 709,412 $ 571,839 24 % NA Opzelura 118,705 85,724 38 % 39 % Iclusig 29,544 30,343 (3 %) — % Pemazyre 18,440 17,676 4 % 6 % Minjuvi/ Monjuvi 29,551 23,874 24 % 25 % Niktimvo 13,613 — NM NA Zynyz 3,009 467 544 % NA Total net product revenues 922,274 729,923 26 % 27 % Royalty revenues: Jakavi 92,145 89,595 3 % 6 % Olumiant 30,800 30,589 1 % 6 % Tabrecta 6,413 5,234 23 % NA Other 1,266 548 131 % NM Total royalty revenues 130,624 125,966 4 % Total net product and royalty revenues 1,052,898 855,889 23 % Milestone and contract revenues — 25,000 — % — % Total GAAP revenues $ 1,052,898 $ 880,889 20 % NM = not meaningful NA = not applicable 1 Percentage change in constant currency is calculated using 2024 foreign exchange rates to recalculate 2025 results. Expand Product and Royalty Revenues Total net product and royalty revenues for the quarter ended March 31, 2025 increased 23% over the prior year comparative period. Total net product revenues for the quarter ended March 31, 2025 increased 26% over the prior year comparative period primarily driven by the following: Jakafi net product revenue increased 24% versus the prior year comparable period, driven by an increase in paid demand of 10% reflecting continued demand growth in all indications, the positive impact of the Part D redesign under the Inflation Reduction Act, partially offset by growth in 340B, and 7% favorable impact from less de-stocking compared to the first quarter of 2024. Jakafi inventory levels were within normal range at the end of the first quarter of 2025. Opzelura net product revenue increased 38% due to continued growth in new patient starts and refills in the U.S. with U.S. paid demand up 24% versus the first quarter of 2024, partially offset by a reduction in channel inventory, and increased contribution from ex-U.S. driven by continued uptake in Germany and France, as well as growth from the recent launches in Italy and Spain. Opzelura inventory levels were within normal range at the end of the first quarter of 2025. Minjuvi/Monjuvi net product revenue increased 24% as a result of the first quarter of 2025 reflecting three months of net product revenues in the U.S., compared to two months of net product revenue in the first quarter of 2024 due to the acquisition of U.S. rights to Monjuvi, which closed in February 2024. Niktimvo net product revenue driven by the commercial launch of the product during the first quarter of 2025. Operating Expenses Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter ended March 31, 2025 increased 20% and 22% respectively, compared to the same period in 2024 primarily due to increased royalty expense. Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended March 31, 2025 increased 2% and 3%, respectively, compared to the same period in 2024, reflecting continued investment in our late stage development assets and timing of certain expenses. Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended March 31, 2025 increased 8% and 9%, respectively, compared to the same period in 2024 primarily due to timing of consumer marketing activities and of certain other expenses. Other Financial Information Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended March 31, 2025, compared to the same period in 2024, was primarily due to fluctuations in foreign currency exchange rates impacting future revenue projections of Iclusig. Operating income GAAP and Non-GAAP operating income for the three months ended March 31, 2025 increased 123% and 76%, respectively, compared to the same period in 2024, driven primarily by growth in net product revenue. Cash, cash equivalents and marketable securities position As of March 31, 2025 and December 31, 2024, cash, cash equivalents and marketable securities totaled $2.4 billion and $2.2 billion, respectively. 2025 Financial Guidance Incyte's guidance for the fiscal year 2025 is summarized below. Incyte is raising its full year 2025 Jakafi revenue guidance. Guidance for Opzelura includes net product revenue for pediatric atopic dermatitis which has an anticipated approval in the second half of 2025. Guidance for other oncology net product revenues include net product revenue for Monjuvi in follicular lymphoma and Zynyz in squamous cell anal carcinoma. Approvals for these indications are anticipated in the second half of 2025. Guidance for research and development excludes the $15 million of expense for the full year 2025 related to our recently announced collaboration with Genesis. 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, 13753168. 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, 13753168. The conference call will also be webcast live and can be accessed at About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. About Jakafi ® (ruxolitinib) Jakafi ® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for 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-polycythemia vera 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. Jakafi is a registered trademark of Incyte. About Opzelura ® (ruxolitinib) Cream Opzelura ® (ruxolitinib) cream, a novel cream formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved 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 12 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 non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. Opzelura and the Opzelura logo are registered trademarks of Incyte. About Monjuvi ® (tafasitamab-cxix) Monjuvi ® (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. 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). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. Following accelerated approval by the U.S. Food and Drug Administration in July 2020, Monjuvi ® (tafasitamab-cxix) is being commercialized in the United States by Incyte. In Europe, Minjuvi ® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in August 2021. XmAb ® is a registered trademark of Xencor, Inc. Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the 'triangle' design are (registered) trademarks of Incyte. About Pemazyre ® (pemigatinib) Pemazyre ® (pemigatinib) is a kinase inhibitor indicated in the United States 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 a confirmatory trial(s). Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, 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 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 TKIs. In the EU, Iclusig is approved 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. Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, 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) is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. Zynyz is a 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 graft-versus-host disease (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 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax 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. All other trademarks are the property of their respective owners. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this release contain predictions, estimates and other forward-looking statements, including any discussion of the following: Incyte's potential for continued performance and growth; Incyte's ability to achieve both its full-year and long-term objectives; Incyte's financial guidance for 2025, including its expectations regarding sales of and demand for Jakafi and Opzelura; expected revenue contribution from Niktimvo and additional near-term launches; the potential of povorcitinib to be a multibillion-dollar product; the possibility for 2025 to be a transformational year for Incyte in terms of launches, phase 3 study initiations, pivotal readouts and proof of concept readouts; Incyte's potential to have more than 10 high impact launches by 2030; the potential and progress of programs in our pipeline; ongoing clinical trials and clinical trials that may be initiated; expectations regarding discussions with regulators, regulatory submissions and regulatory approvals; plans to present data at upcoming medical conferences; Incyte's exposure to potential tariffs; and 2025 newsflow items. These forward-looking statements are based on Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: further research and development and the results of clinical trials possibly being unsuccessful or insufficient 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; determinations made by the FDA, EMA and other regulatory agencies; Incyte's dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of Incyte's products and the products of Incyte's collaboration partners; the acceptance of Incyte's products and the products of Incyte's collaboration partners in the marketplace; market competition; unexpected variations in the demand for Incyte's products and the products of Incyte's collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte's products and the products of Incyte's collaboration partners; sales, marketing, manufacturing and distribution requirements, including Incyte's and its collaboration partners' ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; variations in foreign currency exchange rates; and other risks detailed in Incyte's reports filed with the Securities and Exchange Commission, including its annual report on form 10-K for the year ended December 31, 2024. Incyte disclaims any intent or obligation to update these forward-looking statements. INCYTE CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands) March 31, 2025 December 31, 2024 ASSETS Cash, cash equivalents and marketable securities $ 2,408,658 $ 2,158,092 Accounts receivable 823,134 853,154 Property and equipment, net 765,359 763,411 Finance lease right-of-use assets, net 29,892 30,803 Inventory 429,286 407,199 Prepaid expenses and other assets 243,470 181,382 Equity investments 17,463 18,814 Other intangible assets, net 107,611 113,803 Goodwill 155,593 155,593 Deferred income tax asset 768,899 762,071 Total assets $ 5,749,365 $ 5,444,322 LIABILITIES AND STOCKHOLDERS' EQUITY Accounts payable, accrued expenses and other liabilities $ 1,849,681 $ 1,765,733 Finance lease liabilities 37,121 37,961 Acquisition-related contingent consideration 195,000 193,000 Stockholders' equity 3,667,563 3,447,628 Total liabilities and stockholders' equity $ 5,749,365 $ 5,444,322 Expand INCYTE CORPORATION (unaudited, in thousands, except per share amounts) Three Months Ended March 31, 2025 2024 GAAP Net Income $ 158,203 $ 169,548 Adjustments 1: Non-cash stock compensation from equity awards (R&D) 2 36,724 36,792 Non-cash stock compensation from equity awards (SG&A) 2 23,399 22,373 Non-cash stock compensation from equity awards (COGS) 2 859 613 Non-cash interest 3 82 108 Loss (gain) on equity investments 4 1,343 (99,947 ) Amortization of acquired product rights 5 5,384 5,384 Loss (gain) on change in fair value of contingent consideration 6 11,572 (456 ) MorphoSys transition costs 7 — 4,579 Escient acquisition related compensation expense 8 535 — Tax effect of Non-GAAP pre-tax adjustments 9 (8,642 ) (6,275 ) Non-GAAP Net Income $ 229,459 $ 132,719 Non-GAAP net income per share: Basic $ 1.18 $ 0.59 Diluted $ 1.16 $ 0.58 Shares used in computing Non-GAAP net income per share: Diluted 198,197 227,219 1 Included within the Milestone and contract revenues line item in the Condensed Consolidated Statements of Operations (in thousands) for the three months ended March 31, 2025 are milestones of $0 earned from our collaborative partners, as compared to $25,000 of milestones earned for the three months ended March 31, 2024. Included within the Research and development expenses line item in the Condensed Consolidated Statements of Operations (in thousands) for the three months ended March 31, 2025 and 2024 are upfront consideration and milestones of $15,500 and $1,000, respectively, related to our collaborative partners. 2 As included within the Cost of product revenues (including definite-lived intangible amortization) line item; the Research and development expenses line item; and the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations. 3 As included within the Interest expense line item in the Condensed Consolidated Statements of Operations. 4 As included within the (Loss) gain on equity investments line item in the Condensed Consolidated Statements of Operations. 5 As included within the Cost of product revenues (including definite-lived intangible amortization) line item in the Condensed Consolidated Statements of Operations. Acquired product rights of licensed intellectual property for Iclusig is amortized utilizing a straight-line method over the estimated useful life of 12.5 years. 6 As included within the Loss (gain) on change in fair value of acquisition-related contingent consideration line item in the Condensed Consolidated Statements of Operations. 7 Included within the Research and development line item in the Condensed Consolidated Statements of Operations (in thousands) is $4,031 for the three months ended March 31, 2024, and $548 is included within the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations (in thousands) for the three months ended March 31, 2024. MorphoSys transition costs primarily represent employee related costs to transition research and development and selling, general and administrative activities to us under the former collaboration agreement with MorphoSys. 8 Included within the Research and development line item in the Condensed Consolidated Statements of Operations (in thousands) is $535 for the three months ended March 31, 2025. Escient acquisition related compensation expense represents non-recurring charges associated with severance payments to former Escient employees. 9 Income tax effects of Non-GAAP pre-tax adjustments are calculated using an estimated annual effective tax rate, taking into consideration any permanent items and valuation allowances against related deferred tax assets. The Non-GAAP net income for the three months ended March 31, 2024 should have been $132,719 compared to the $145,269 previously disclosed to correct a transposition error in the tax effect of Non-GAAP pre-tax adjustments. For the three months ended March 31, 2024, the tax effect of Non-GAAP pre-tax adjustments should have been ($6,275) instead of $6,275. This correction is reflected in the table above. Expand
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29-04-2025
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Incyte (NASDAQ:INCY) Delivers Strong Q1 Numbers
Biopharmaceutical company Incyte Corporation (NASDAQ:INCY) reported Q1 CY2025 results exceeding the market's revenue expectations , with sales up 19.5% year on year to $1.05 billion. Its non-GAAP profit of $1.16 per share was 10.6% above analysts' consensus estimates. Is now the time to buy Incyte? Find out in our full research report. Revenue: $1.05 billion vs analyst estimates of $988.8 million (19.5% year-on-year growth, 6.5% beat) Adjusted EPS: $1.16 vs analyst estimates of $1.05 (10.6% beat) "The double-digit revenue growth in the first quarter driven by the continued growth of Jakafi and Opzelura and the recent launch of Niktimvo, puts us on track to achieve our full year objectives" Operating Margin: 19.5%, up from 10.4% in the same quarter last year Market Capitalization: $11.52 billion "The double-digit revenue growth in the first quarter driven by the continued growth of Jakafi and Opzelura and the recent launch of Niktimvo, puts us on track to achieve our full year objectives," said Hervé Hoppenot, Chief Executive Officer, Incyte. Founded in 1991 and evolving from a genomics research firm to a commercial-stage drug developer, Incyte (NASDAQ:INCY) is a biopharmaceutical company that discovers, develops, and commercializes proprietary therapeutics for cancer and inflammatory diseases. A company's long-term sales performance can indicate its overall quality. Any business can experience short-term success, but top-performing ones enjoy sustained growth for years. Luckily, Incyte's sales grew at a solid 14.6% compounded annual growth rate over the last five years. Its growth beat the average healthcare company and shows its offerings resonate with customers. Long-term growth is the most important, but within healthcare, a half-decade historical view may miss new innovations or demand cycles. Incyte's annualized revenue growth of 12.8% over the last two years is below its five-year trend, but we still think the results suggest healthy demand. This quarter, Incyte reported year-on-year revenue growth of 19.5%, and its $1.05 billion of revenue exceeded Wall Street's estimates by 6.5%. Looking ahead, sell-side analysts expect revenue to grow 8.3% over the next 12 months, a deceleration versus the last two years. Despite the slowdown, this projection is healthy and implies the market is baking in success for its products and services. Today's young investors likely haven't read the timeless lessons in Gorilla Game: Picking Winners In High Technology because it was written more than 20 years ago when Microsoft and Apple were first establishing their supremacy. But if we apply the same principles, then enterprise software stocks leveraging their own generative AI capabilities may well be the Gorillas of the future. So, in that spirit, we are excited to present our Special Free Report on a profitable, fast-growing enterprise software stock that is already riding the automation wave and looking to catch the generative AI next. Incyte has done a decent job managing its cost base over the last five years. The company has produced an average operating margin of 14%, higher than the broader healthcare sector. Analyzing the trend in its profitability, Incyte's operating margin decreased by 14.5 percentage points over the last five years. The company's two-year trajectory also shows it failed to get its profitability back to the peak as its margin fell by 10.1 percentage points. This performance was poor no matter how you look at it - it shows its expenses were rising and it couldn't pass those costs onto its customers. This quarter, Incyte generated an operating profit margin of 19.5%, up 9.1 percentage points year on year. This increase was a welcome development and shows it was more efficient. Revenue trends explain a company's historical growth, but the long-term change in earnings per share (EPS) points to the profitability of that growth – for example, a company could inflate its sales through excessive spending on advertising and promotions. Incyte's full-year EPS flipped from negative to positive over the last five years. This is encouraging and shows it's at a critical moment in its life. In Q1, Incyte reported EPS at $1.16, up from $0.58 in the same quarter last year. This print easily cleared analysts' estimates, and shareholders should be content with the results. Over the next 12 months, Wall Street expects Incyte's full-year EPS of $1.84 to grow 220%. We were impressed by how significantly Incyte blew past analysts' revenue expectations this quarter. We were also happy its EPS outperformed Wall Street's estimates. Zooming out, we think this was a solid quarter. The stock remained flat at $59.52 immediately after reporting. Indeed, Incyte had a rock-solid quarterly earnings result, but is this stock a good investment here? When making that decision, it's important to consider its valuation, business qualities, as well as what has happened in the latest quarter. We cover that in our actionable full research report which you can read here, it's free. Sign in to access your portfolio
