Nektar Therapeutics (NKTR) incurred an adjusted loss per share of 15 cents in the fourth quarter of 2024, wider than the Zacks Consensus Estimate of a loss of 13 cents. In the year-ago quarter, the company had incurred a loss of 22 cents per share.See the Zacks Earnings Calendar to stay ahead of market-making news.Total revenues in the fourth quarter increased 22.2% year over year to $29.2 million. The reported figure however missed the Zacks Consensus Estimate of $39 million.In the past year, shares of Nek ...

Nektar Therapeutics (NKTR) Q4 2024 Earnings Call March 13, 2025 01:38 AM ET Company Participants Vivian Wu - Director of Investor Relations & Corporate AffairsHoward W. Robin - CEO, President & DirectorBrian Kotzin - Interim Chief Medical OfficerJonathan Zalevsky - Senior VP & Chief Research and Development OfficerSandra Gardiner - Chief Financial OfficerJulian Harrison - Managing DirectorMayank Mamtani - Senior Managing Director Conference Call Participants Yasmeen Rahimi - Sr. Research AnalystJay Olson - ...

Core Insights - Nektar Therapeutics reported a revenue of $29.18 million for the quarter ended December 2024, reflecting a year-over-year increase of 22.1% [1] - The earnings per share (EPS) was $0.15, a significant improvement from -$0.22 in the same quarter last year, resulting in an EPS surprise of +215.38% compared to the consensus estimate of -$0.13 [1] - The reported revenue fell short of the Zacks Consensus Estimate of $39.02 million by 25.23% [1] Revenue Breakdown - Product sales reached $12.87 million, exceeding the average estimate of $9.76 million from eight analysts, marking a year-over-year increase of 134.8% [4] - Non-cash royalty revenue related to future royalties was $16.24 million, slightly above the estimated $15.15 million, but showed a decline of 10.1% compared to the previous year [4] - License, collaboration, and other revenue was only $0.06 million, significantly below the average estimate of $28.26 million from four analysts, representing a year-over-year decrease of 81.5% [4] Stock Performance - Nektar's shares have returned +23.5% over the past month, contrasting with a -8.2% change in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 2 (Buy), suggesting potential for outperformance in the near term [3]

Financial Performance - Revenue for Q4 2024 was $29.2 million, a 22.1% increase from $23.9 million in Q4 2023[4] - Net income for Q4 2024 was $7.3 million, compared to a net loss of $42.1 million in Q4 2023[9] - The net loss for the full year 2024 was $119.0 million, an improvement from a net loss of $276.1 million in 2023[9] - The company reported a net income of $7,261,000 in Q4 2024, a turnaround from a net loss of $42,079,000 in Q4 2023[22] - Basic net income per share improved to $0.03 in Q4 2024, compared to a loss of $0.22 per share in Q4 2023[22] Operating Costs and Expenses - Total operating costs and expenses for Q4 2024 were $14.8 million, significantly down from $57.4 million in Q4 2023, primarily due to a $40.4 million gain from the sale of the Huntsville manufacturing facility[5] - G&A expenses for the full year 2024 were $76.8 million, slightly down from $77.4 million in 2023, indicating cost management efforts[7] Research and Development - R&D expenses for the full year 2024 were $120.9 million, up from $114.2 million in 2023, driven by increased development expenses for rezpegaldesleukin[6] - Research and development expenses for the year totaled $120,908,000, up from $114,162,000 in 2023, marking a 6% increase[22] - The company completed enrollment for the Phase 2b trials of rezpegaldesleukin in atopic dermatitis and alopecia areata, with topline data expected in Q2 and Q4 2025, respectively[3] - Nektar plans to submit the IND for NKTR-0165 in the second half of 2025, expanding its immunology pipeline[3] Sales and Revenue Growth - Product sales increased significantly to $12,874,000 in Q4 2024, compared to $5,483,000 in Q4 2023, representing a 134% growth[22] - Total revenue for Q4 2024 reached $29,175,000, a 22% increase from $23,885,000 in Q4 2023[22] Assets and Liabilities - Total assets decreased to $303,850,000 in 2024 from $398,033,000 in 2023, reflecting a 24% decline[20] - Total liabilities were reduced to $243,113,000 in 2024, down from $267,046,000 in 2023, indicating a 9% decrease[20] - Total stockholders' equity decreased to $60,737,000 in 2024 from $130,987,000 in 2023, a decline of 53%[20] Other Significant Events - Nektar announced a definitive agreement to sell its commercial PEGylation manufacturing business for $90 million, which includes $70 million in cash[12] - The FDA granted Fast Track designation for rezpegaldesleukin for treating moderate-to-severe atopic dermatitis in patients aged 12 and older[11] - The company recorded a gain of $40,390,000 from the sale of the Huntsville manufacturing facility in Q4 2024[22] - Non-cash royalty revenue related to future royalties was $16,238,000 in Q4 2024, slightly down from $18,061,000 in Q4 2023[22]

Core Insights - Nektar Therapeutics reported a net income of $7.3 million for Q4 2024, a significant improvement from a net loss of $42.1 million in Q4 2023, indicating a positive shift in financial performance [8] - The company achieved total revenue of $29.2 million in Q4 2024, up from $23.9 million in Q4 2023, and a total annual revenue of $98.4 million for 2024, compared to $90.1 million in 2023, reflecting growth in product sales and other revenue streams [3][14] - Nektar's cash and investments in marketable securities decreased to $269.1 million as of December 31, 2024, from $329.4 million a year earlier, but are expected to support operations until Q4 2026 [1] Financial Performance - Total operating costs and expenses for Q4 2024 were $14.8 million, significantly lower than $57.4 million in Q4 2023, primarily due to a $40.4 million gain from the sale of the Huntsville manufacturing facility [4][15] - Research and development (R&D) expenses for Q4 2024 were $28.7 million, slightly down from $29.9 million in Q4 2023, while total R&D expenses for the year increased to $120.9 million from $114.2 million in 2023 [5][14] - General and administrative (G&A) expenses remained stable at $17.1 million for Q4 2024 compared to $17.3 million in Q4 2023, with total G&A expenses for the year at $76.8 million, down from $77.4 million in 2023 [6][14] Business Developments - Nektar is advancing its immunology pipeline, with two Phase 2b trials for rezpegaldesleukin now fully enrolled, expecting topline data in Q2 and Q4 2025 [2] - The company reported progress in preclinical programs, including the first data for NKTR-0165 and the introduction of a new bispecific antibody, NKTR-0166, with plans to submit an IND for NKTR-0165 in the second half of 2025 [2] - Nektar's lead product candidate, rezpegaldesleukin, is being evaluated for chronic autoimmune disorders, positioning the company for potential value creation in the upcoming year [2][11]

Core Insights - Nektar Therapeutics will announce its financial results for Q4 and the full year ended December 31, 2024, on March 12, 2025, after U.S. market close [1] - The conference call to discuss the results will be hosted by Howard Robin, President and CEO, at 5:00 p.m. Eastern Time [1] Company Overview - Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments for autoimmune and chronic inflammatory diseases [3] - The lead product candidate is rezpegaldesleukin (REZPEG or NKTR-358), a first-in-class regulatory T cell stimulator currently in two Phase 2b clinical trials for atopic dermatitis and alopecia areata [3] - The pipeline includes a preclinical bivalent TNFR2 antibody, bispecific programs NKTR-0165 and NKTR-0166, and a modified CSF protein NKTR-422 [3] - Nektar is also evaluating NKTR-255, an investigational IL-15 receptor agonist aimed at enhancing the immune system's ability to combat cancer, in several ongoing clinical trials [3] - The company is headquartered in San Francisco, California [3]

Core Insights - Nektar Therapeutics has completed target enrollment in its Phase 2b study of rezpegaldesleukin for severe-to-very-severe alopecia areata, achieving an enrollment of 84 patients [1][2] Company Overview - Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments for autoimmune and chronic inflammatory diseases, with rezpegaldesleukin as its lead product candidate [9] - Rezpegaldesleukin is a first-in-class regulatory T cell stimulator being evaluated in two Phase 2b clinical trials, one for alopecia areata and another for atopic dermatitis [9] Study Details - The REZOLVE-AA study enrolled patients with severe-to-very-severe alopecia areata who have not previously received JAK inhibitors or other biologics, with randomization across two dose regimens of rezpegaldesleukin or placebo [2][4] - The primary efficacy endpoint is the mean percent change in the Severity of Alopecia Tool (SALT) score at the end of a 36-week induction period, with secondary endpoints including the proportion of participants achieving a 50% reduction in SALT score [2][4] Clinical Context - Alopecia areata is an autoimmune disease affecting hair follicles, with a lifetime incidence of 2% in both men and women, impacting approximately 6.7 million people in the U.S. and 160 million worldwide [7][8] - Current therapies for alopecia areata have high relapse rates and there is a significant unmet medical need for more effective treatments [8] Mechanism of Action - Rezpegaldesleukin targets the interleukin-2 receptor complex to stimulate the proliferation of regulatory T cells, potentially restoring immune system balance in autoimmune conditions [5][6]

Core Viewpoint - Nektar Therapeutics and TrialNet have announced a collaboration to conduct a Phase 2 clinical trial evaluating the safety and efficacy of rezpegaldesleukin in patients with new onset stage 3 type 1 diabetes mellitus (T1D) [1][2][3] Company Overview - Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments for autoimmune and chronic inflammatory diseases, with rezpegaldesleukin as its lead product candidate [10] - Rezpegaldesleukin is a novel agonistic T regulatory (Treg) cell biologic designed to restore immune balance and dampen inflammatory responses [2][5] - The drug is wholly owned by Nektar and is also being evaluated in clinical trials for atopic dermatitis and alopecia areata [6][10] Clinical Trial Details - The Phase 2 trial will be randomized, double-blind, and placebo-controlled, involving approximately 70 adults and children with new onset stage 3 T1D [2][3] - The study aims to measure the efficacy of rezpegaldesleukin using a mixed meal tolerance test (MMTT) over a 12-month period, including a 6-month treatment phase and a 6-month follow-up [3] - Secondary objectives will include pharmacokinetics, pharmacodynamics, and assessments of HbA1c levels and patient insulin requirements [3] Industry Context - Type 1 diabetes (T1D) is an immune-mediated disease characterized by the destruction of insulin-producing beta cells, leading to lifelong dependence on insulin [9] - Preservation of residual beta-cell function at diagnosis can improve glycemic control and reduce long-term complications [9] - TrialNet is the largest clinical trial network focused on changing the course of T1D, aiming to prevent the disease and preserve insulin production [11]

Company Overview - Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments for autoimmune and chronic inflammatory diseases [5] - The company's lead product candidate, rezpegaldesleukin (REZPEG or NKTR-358), is a first-in-class regulatory T cell stimulator [5] - Nektar's pipeline includes additional candidates such as a preclinical bivalent TNFR2 antibody and bispecific programs, NKTR-0165 and NKTR-0166, as well as NKTR-422, a modified hematopoietic colony stimulating factor [5] Product Development - Rezpegaldesleukin is being developed as a self-administered injection for various autoimmune and inflammatory diseases [3] - It is currently evaluated in two Phase 2b clinical trials: the REZOLVE-AD study for moderate-to-severe atopic dermatitis and the REZOLVE-AA study for severe-to-very-severe alopecia areata [3] - The FDA has granted Fast Track designation for rezpegaldesleukin for treating patients aged 12 and older with moderate-to-severe atopic dermatitis [4] Upcoming Events - Nektar Therapeutics will host a virtual investor and analyst event with Type 1 Diabetes experts on February 24, 2025 [1] - The event will be led by Nektar's Chief Research & Development Officer, Jonathan Zalevsky, and will feature leading diabetes experts [1][7]

Core Insights - Nektar Therapeutics announced that the FDA has granted Fast Track designation for rezpegaldesleukin, aimed at treating moderate-to-severe atopic dermatitis in patients aged 12 and older who do not respond adequately to topical therapies [1][3] Group 1: Product Development - Rezpegaldesleukin is an investigational biologic therapy that targets the interleukin-2 receptor complex to stimulate regulatory T cells (Tregs) [1][8] - The drug has shown rapid improvement in disease outcomes during a 12-week induction phase and sustained effects for at least 36 weeks post-treatment [2] - The Phase 2b REZOLVE-AD study has enrolled 398 patients and aims to assess the mean improvement in Eczema Area and Severity Index (EASI) score after a 16-week treatment period [4][5] Group 2: Clinical Trials - The REZOLVE-AD study began in October 2023, with patient enrollment across approximately 110 sites globally, including 67% in Europe and 17% in the United States [6] - The primary endpoint of the study is the mean improvement in EASI score, with secondary endpoints including the proportion of patients achieving specific assessment scores [5] - Enrollment criteria included a minimum EASI score of 16.0 and a minimum Body Surface Area (BSA) of 10% [7] Group 3: Market Potential - Atopic dermatitis affects around 30 million people in the United States, indicating a significant market opportunity for effective treatments [10] - The Fast Track designation allows for closer collaboration with the FDA, potentially expediting the development and approval process for rezpegaldesleukin [3]