MONTREAL, March 26, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX:GUD) ("Knight"), a pan-American (ex-US) specialty pharmaceutical company, announced today the launch of Minjuvi® (tafasitamab) by its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V. Minjuvi® in combination with lenalidomide, followed by Minjuvi® monotherapy, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), who are not eligible for autologous stem cel ...

A less-than-encouraging clinical trial for an investigative medicine was the news driving down Incyte (INCY 2.28%) stock over the past few days. The gloom this produced was pushing the biotech's share price down by nearly 11% week to date as of Friday before market open.Clinical trials for investigational skin disorder drug fell shortOn Monday, Incyte published the top-line results from two phase 3 trials of its povorcitinib, a treatment aimed at combating moderate to severe hidradenitis suppurativa (HS), a ...

Shares of Incyte (INCY) were down 8.62% on Monday after the announcement of data from two late-stage studies on an oral small-molecule JAK1 inhibitor, povorcitinib, for the treatment of hidradenitis suppurativa (HS).HS, a chronic inflammatory skin condition, is characterized by painful nodules and abscesses.While both the late studies STOP-HS1 and STOP-HS2 studies met their primary endpoint, the results lagged investor expectations, and consequently, shares declined.Shares of Incyte have lost 7.2% in the pa ...

Group 1 - Incyte announced positive results from its phase 3 studies STOP-HS1 and STOP-HS2, utilizing the drug povorcitinib for treatment [2] - The studies are significant as they represent late-stage clinical trials, indicating the drug's potential effectiveness in the market [2] Group 2 - The Biotech Analysis Central service offers extensive resources for investors, including a library of over 600 biotech articles and a model portfolio of small and mid-cap stocks [2] - The service is available for $49 per month, with a discounted yearly plan at $399, providing a 33.50% savings [1]

A month has gone by since the last earnings report for Incyte (INCY) . Shares have added about 2.6% in that time frame, outperforming the S&P 500.Will the recent positive trend continue leading up to its next earnings release, or is Incyte 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.How Have Estimates Been Moving Since Then?It turns out, estimate ...

Core Insights - Incyte announced positive results from two late-stage studies for ruxolitinib cream 1.5% in treating prurigo nodularis (PN) [1][10] - The TRuE-PN1 study achieved its primary endpoint, showing significant improvement in itch relief compared to vehicle control [5][7] - The TRuE-PN2 study showed a positive trend across key secondary endpoints, although the primary endpoint did not reach statistical significance [9][10] Company Overview - Ruxolitinib cream 1.5% is a topical JAK1/2 inhibitor, currently approved for nonsegmental vitiligo and mild to moderate atopic dermatitis in the U.S. [3] - The cream is indicated for a chronic inflammatory skin condition affecting approximately 200,000 people in the U.S., primarily those aged 40-69 [2] Study Results - In the TRuE-PN1 study, 44.6% of patients using Opzelura experienced a ≥4-point improvement in the Worst-Itch Numeric Rating Scale (WI-NRS4) at Week 12 compared to 20.6% in the control group [5] - Significant itch relief was observed as early as Day 7, with 22.4% of patients achieving relief compared to 8% in the control group [6] - The study met all key secondary endpoints, with 15.8% of Opzelura patients achieving treatment success on the Investigator's Global Assessment for Stage of Chronic Prurigo (IGA-CPG-S-TS) compared to 3.9% in the control group [7] Safety Profile - Opzelura was generally safe and well-tolerated in both studies, with no new safety signals observed [10] - The safety profile was consistent with previous data, indicating a favorable risk-benefit ratio for patients [10] Future Steps - Results from the TRuE-PN1 and TRuE-PN2 studies will guide discussions with regulatory authorities regarding next steps for Opzelura [11]

Group 1 - Incyte Corp. (NASDAQ: INCY) is a biotechnology company operating in the healthcare sector [1] - The company was previously discussed in July 2022, with a bullish outlook on its shares [1] - The focus is on building financial assets for retirement through various trading strategies, including long and short positions [1] Group 2 - The article does not contain any disclosures regarding stock or derivative positions in Incyte Corp. [2] - The author expresses personal opinions and is not receiving compensation for the article, aside from Seeking Alpha [2] - There is no business relationship with any company mentioned in the article [2]

Group 1 - Brendan completed a Ph.D. at Stanford University in organic synthesis in 2009 [1] - He worked for Merck from 2009 to 2013 and has experience in biotech startups such as Theravance and Aspira [1] - Brendan is a co-founder of 1200 Pharma, which spun out of Caltech and received significant investment in the 8 figures [1] Group 2 - Brendan remains an avid investor focused on market trends, particularly in biotechnology stocks [1]

Financial Performance - Total revenues for the year ended December 31, 2024, were $4,241.2 million, a 14.8% increase from $3,695.6 million in 2023 [454]. - Product revenues, net, reached $3,618.9 million, up from $3,165.2 million in 2023, reflecting a 14.3% growth [454]. - The net income for 2024 was $32.6 million, a substantial decrease from $597.6 million in 2023 [454]. - Cash flows from operating activities for 2024 were $335,337 thousand, a decrease of 32.4% from $496,487 thousand in 2023 [461]. - Total stockholders' equity as of December 31, 2024, was $3,447,628 thousand, down from $5,189,837 thousand in 2023 [459]. - Net income for the year ended December 31, 2024, was $32,615 thousand, a decrease of 94.5% compared to $597,599 thousand in 2023 [461]. Research and Development - The company anticipates continued significant expenses in drug discovery and development, which may lead to future losses and challenges in achieving sustained profitability [310]. - Drug discovery and development expenditures are expected to increase as the company focuses on preclinical tests and clinical trials necessary for regulatory approval [311]. - Research and development expenses increased significantly to $2,606.8 million, compared to $1,627.6 million in 2023, marking a 60% rise [454]. - The company recognized a total of $679.4 million as research and development expenses related to the Escient acquisition [443]. - Research and development expenses include costs for clinical trials and pharmaceutical development, with amounts funded by collaborations recognized as incurred [507]. Acquisitions and Collaborations - The company acquired Escient Pharmaceuticals for $782.5 million, with $644.8 million allocated to the lead molecule EP262 as in-process research and development expenses [443]. - The company acquired exclusive global rights to tafasitamab for $25 million on February 5, 2024, enhancing its product portfolio [534]. - The Novartis collaboration agreement has generated $157.0 million in development milestones, $345.0 million in regulatory milestones, and $200.0 million in sales milestones since inception [546]. - The company entered into a collaboration agreement with China Medical Systems Holdings Limited for povorcitinib, recognizing an upfront payment of $25 million [576]. - The agreement with MacroGenics allows the company exclusive rights to develop and commercialize INCMGA0012, with total milestone payments to MacroGenics amounting to $215 million since inception [566]. Revenue Sources - The company derives a substantial portion of its revenues from royalties and milestone payments under collaboration agreements, with significant reliance on JAKAVI and OLUMIANT royalties [324]. - JAKAFI revenues increased to $2,792,107 in 2024, up 7.7% from $2,593,732 in 2023 [521]. - OPZELURA revenues grew significantly to $508,293 in 2024, a 50.4% increase from $337,864 in 2023 [521]. - Product royalty revenues from Novartis net sales of JAKAVI were $418.8 million in 2024, up from $367.6 million in 2023 [550]. - The Lilly agreement has resulted in $135.6 million in product royalty revenues related to OLUMIANT in 2024, consistent with previous years [555]. Financial Risks and Liabilities - The company may require additional capital in the future to fund its business plan and research and development efforts, depending on various factors including revenue generation and potential acquisitions [314]. - Changes in tax laws, such as the Tax Cuts and Jobs Act and the Inflation Reduction Act, could adversely affect the company's tax liabilities and financial condition [323]. - The company faces risks related to intellectual property, including potential litigation and the need to defend against infringement claims, which could disrupt drug development efforts [325]. - Current liabilities increased to $1,641.8 million in 2024, up from $1,240.4 million in 2023 [451]. - Total accrued and other current liabilities rose to $1.21 billion in 2024, up from $935.6 million in 2023, representing an increase of approximately 29% [591]. Inventory and Assets - Total inventory increased to $407.2 million in 2024 from $269.9 million in 2023, with raw materials at $27.6 million and API at $331.2 million [543]. - As of December 31, 2024, marketable securities totaled $470.3 million, primarily composed of U.S. government securities [428]. - Total assets decreased to $5,444.3 million in 2024 from $6,782.1 million in 2023 [451]. - The fair value of government debt securities increased to $470,263 as of December 31, 2024, from $442,667 in 2023 [522]. Operational and IT Risks - The company faces significant risks related to data security breaches, which could lead to loss of confidential information and reputational harm [339]. - The company is subject to potential fines under the General Data Protection Regulation, with fines up to €20 million or 4% of annual global revenue for noncompliance [342]. - The company is currently implementing a new enterprise resource planning system to support planned growth and manufacturing operations [338]. - The company is continuously evaluating and enhancing IT systems to address planned growth, which involves inherent costs and risks [338]. Stock and Equity - The company repurchased common stock amounting to $2,004,790 thousand in 2024, significantly impacting cash flows [461]. - Cash, cash equivalents, and restricted cash at the end of 2024 were $1,689,451 thousand, down from $3,215,221 thousand at the end of 2023 [461]. - The company assessed expected credit losses as de minimis, indicating strong creditworthiness of third-party sales relationships [533].

Core Viewpoint - Incyte Corporation reported mixed financial results for Q4 2024, with adjusted earnings per share falling short of estimates, while total revenues exceeded expectations, driven by strong performance from its key drugs Jakafi and Opzelura [1][2][3]. Financial Performance - Adjusted earnings for Q4 2024 were $1.43 per share, missing the Zacks Consensus Estimate of $1.53, compared to $1.06 per share in the same quarter last year [1]. - Total revenues for Q4 2024 reached $1.18 billion, reflecting a 16% year-over-year growth, surpassing the Zacks Consensus Estimate of $1.15 billion [2]. - For the full year 2024, Incyte generated revenues of $4.24 billion, indicating approximately 15% growth year over year, while adjusted earnings per share decreased to $1.08 from $3.52 in the previous year [12]. Drug Performance - Jakafi generated revenues of $773.1 million in Q4 2024, an 11% increase from the previous year, driven by a 14% rise in paid demand, exceeding the Zacks Consensus Estimate of $746 million [3]. - Opzelura cream sales reached $161.6 million, a 48% year-over-year increase, surpassing the Zacks Consensus Estimate of $150 million, attributed to growth in new patient starts and refills [4]. - Newly approved Zynyz generated $1.4 million in sales, while Iclusig and Pemazyre reported revenues of $27.4 million and $23.1 million, respectively, with Pemazyre beating its estimate [5]. Expense Overview - Adjusted research and development expenses totaled $420.3 million, up 3% year over year, primarily due to investments in late-stage development assets [10]. - Adjusted selling, general and administrative expenses were $299.7 million, reflecting an 11% increase from the prior year, mainly due to marketing activities [10]. Cash Position - As of December 31, 2024, Incyte's cash, cash equivalents, and marketable securities amounted to $2.2 billion, up from $1.8 billion as of September 30, 2024 [11]. 2025 Guidance - The company anticipates Jakafi revenues between $2.93 billion and $2.98 billion for 2025, with Opzelura net product revenues expected to be in the range of $630 million to $670 million [15]. - Adjusted research and development expenses are projected to be between $1.78 billion and $1.81 billion, while adjusted selling, general and administrative expenses are expected to range from $1.16 billion to $1.19 billion [15]. Recent Developments - Incyte and Syndax Pharmaceuticals received FDA approval for axatilimab-csfr, branded as Niktimvo, for treating GVHD, marking Incyte's second approved treatment for chronic GVHD [16]. - Management indicated that 2025 is expected to be a transformational year with four potential launches and several clinical milestones anticipated [17].