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Nektar(NKTR) - 2025 FY - Earnings Call Transcript
2025-05-20 18:30
Financial Data and Key Metrics Changes - The company ended the fourth quarter with approximately $221 million in cash, providing a runway until the fourth quarter of 2026 with existing operations [40] Business Line Data and Key Metrics Changes - Respag, a drug developed by the company, demonstrated dose-dependent efficacy in a Phase 1b study for atopic dermatitis, with a significant improvement in the eczema area and severity index (EASI) score after correcting previous data errors [4][6] - The Phase 2b study for atopic dermatitis is set to enroll 400 patients, extending the dosing period to 16 weeks and including a maintenance arm for ongoing treatment [14][15] Market Data and Key Metrics Changes - The company is entering the alopecia market, where currently only JAK inhibitors are approved, positioning Respag as a potential first biologic treatment in this space [35] Company Strategy and Development Direction - The company aims to leverage its unique mechanism of action with Respag, which stimulates regulatory T cells, to differentiate itself from existing treatments in the atopic dermatitis and alopecia markets [10][32] - The partnership with TrialNet focuses on the role of Tregs in type 1 diabetes, indicating a strategic move into autoimmune disease prevention [38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the Phase 2b study for atopic dermatitis, citing the robust design and previous positive results as indicators of potential success [16][19] - The company anticipates presenting top-line results for both the atopic dermatitis and alopecia studies in June and December respectively, highlighting a proactive approach to clinical development [34] Other Important Information - The company has transitioned Respag to a wholly owned asset after terminating its collaboration with Eli Lilly, allowing for independent development in multiple clinical trials [2] Q&A Session Summary Question: Can you provide an overview of the Respag history? - The company developed Respag and initially partnered with Eli Lilly in 2017, completing nine clinical studies before terminating the collaboration in April 2023 [2] Question: What are the expectations for the Phase 2b study? - The company aims to replicate the significant efficacy observed in the Phase 1b study, targeting a similar effect size with a larger patient population [19] Question: How is the company addressing the placebo effect in clinical trials? - The company has minimized the US footprint in trial enrollment and ensured that the majority of sites are led by board-certified dermatologists to maintain consistency in disease rating [24][26]
Nektar Therapeutics to Participate in the H.C. Wainwright 3rd Annual BioConnect Investor Conference
Prnewswire· 2025-05-13 21:00
Company Overview - Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments for autoimmune and chronic inflammatory diseases [3] - The company's lead product candidate, rezpegaldesleukin (REZPEG or NKTR-358), is a first-in-class regulatory T cell stimulator currently in two Phase 2b clinical trials for atopic dermatitis and alopecia areata [3] - Nektar's pipeline includes a preclinical bivalent tumor necrosis factor receptor type II (TNFR2) antibody, bispecific programs NKTR-0165 and NKTR-0166, and a modified hematopoietic colony stimulating factor (CSF) protein, NKTR-422 [3] - The company 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] Upcoming Events - Nektar Therapeutics will participate in the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, with a webcast available at 1:30 p.m. Eastern Time [1] - The fireside chat will be accessible via the webcast link and on the Investor Events section of the Nektar website, with a replay available for 30 days [1]
Nektar Q1 Loss Wider Than Expected, Revenues Fall Y/Y, Stock Down
ZACKS· 2025-05-09 14:10
Core Viewpoint - Nektar Therapeutics reported a wider-than-expected adjusted loss in Q1 2025, with significant revenue decline attributed to the sale of its manufacturing facility, leading to a reliance on non-cash royalty revenues [1][2]. Financial Performance - The adjusted loss per share for Q1 2025 was 22 cents, compared to the Zacks Consensus Estimate of an 18-cent loss and a loss of 18 cents in the same quarter last year [1]. - Total revenues for Q1 2025 decreased by 51.4% year-over-year to $10.5 million, missing the Zacks Consensus Estimate of $18 million [1]. - Research and development (R&D) expenses rose to $30.5 million, an increase of approximately 11.3% year-over-year [4]. - General and administrative (G&A) expenses increased by around 20.9% year-over-year to $24.3 million [4]. - As of March 31, 2025, the company had cash and cash equivalents and marketable securities totaling $220.7 million, down from $269.1 million as of December 31, 2024 [4]. Guidance - Nektar anticipates revenues for the remaining three quarters of 2025 to be similar to Q1 levels, projecting total revenues of around $40 million for the full year [5]. - R&D costs for 2025 are expected to range between $110 million and $120 million, while G&A expenses are anticipated to be in the $60-$65 million range [5]. - The company expects to end 2025 with approximately $100 million in cash and investments, which is projected to fund operations into the fourth quarter of 2026 [6]. Pipeline Developments - Nektar's lead pipeline candidate, rezpegaldesleukin (rezpeg), is being developed for various autoimmune and inflammatory diseases, with the company regaining full rights from Eli Lilly in April 2023 [7][8]. - Two phase IIb studies are currently evaluating rezpeg for atopic dermatitis and alopecia areata, with top-line data expected in the coming months [9]. - A new clinical trial agreement was established in February 2025 to evaluate rezpeg in a phase II study for new-onset type 1 diabetes mellitus, expected to start later this year [10]. - Nektar also has two pre-clinical programs, NKTR-0165 and NKTR-0166, with plans to submit an investigational new drug application for NKTR-0165 by the end of 2025 [11].
Nektar Therapeutics (NKTR) Reports Q1 Loss, Lags Revenue Estimates
ZACKS· 2025-05-08 23:25
Core Viewpoint - Nektar Therapeutics reported a quarterly loss of $0.22 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.18, indicating a negative earnings surprise of -22.22% [1] Financial Performance - The company posted revenues of $10.46 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 40.47%, and a significant decline from $21.64 million in the same quarter last year [2] - Over the last four quarters, Nektar has surpassed consensus EPS estimates only once and has topped consensus revenue estimates two times [2] Stock Performance - Nektar shares have declined approximately 34.9% since the beginning of the year, contrasting with the S&P 500's decline of -4.3% [3] - The current Zacks Rank for Nektar is 3 (Hold), suggesting that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.18 on revenues of $17.76 million, and for the current fiscal year, it is -$0.70 on revenues of $70.05 million [7] - The trend of estimate revisions for Nektar is mixed, which could change following the recent earnings report [6] Industry Context - The Medical - Drugs industry, to which Nektar belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8]
Nektar(NKTR) - 2025 Q1 - Earnings Call Transcript
2025-05-08 22:02
Financial Data and Key Metrics Changes - The company ended Q1 2025 with $220.7 million in cash and investments, with no debt on the balance sheet, and expects a cash runway extending into Q4 2026 [27] - Q1 2025 revenue was $10.5 million, primarily from non-cash royalty revenue, with expectations to maintain similar revenue levels for the remainder of 2025, totaling approximately $40 million for the full year [27][28] - R&D expenses for Q1 2025 were $30.5 million, with full-year expectations ranging between $110 million and $120 million [28] - The net loss for Q1 was $50.9 million, equating to a net loss per share of $0.24 [31] Business Line Data and Key Metrics Changes - The company is focusing on the development of its immunology pipeline, particularly the advancement of Respag in three Phase II studies [6][10] - The Respag Phase 2b study for atopic dermatitis has enrolled approximately 400 biologic-naive patients, with results expected in June 2025 [14][20] - The company anticipates reporting top-line results for the Respag AA Phase IIb study in alopecia areata in December 2025 [10][21] Market Data and Key Metrics Changes - There are approximately 30 million adult patients with atopic dermatitis in the US, with about half having moderate to severe disease [9] - The company notes that only about 8% of patients with moderate to severe atopic dermatitis are currently treated with biologics, indicating a significant unmet need in the market [10] Company Strategy and Development Direction - The company aims to establish Respag as a first-in-class T regulatory cell therapy to address various immune disorders, differentiating it from existing treatments [6][10] - The strategy includes advancing multiple drug candidates through clinical trials while maintaining a strong financial position to support these initiatives [13][27] - The company plans to explore partnerships for the Phase III program of Respag, given its current financial position [57] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Respag to address high unmet needs in chronic conditions like atopic dermatitis and alopecia areata [6][10] - The company is optimistic about the upcoming data readouts and their implications for future clinical development [27][90] Other Important Information - The company has implemented measures to control placebo response rates in clinical trials by enrolling a lower percentage of patients from the US and using experienced dermatologists [19][37] - The company recorded a non-cash loss from equity method investment of $4.5 million in Q1 2025, with expectations of a total loss of approximately $10 million for the full year [30] Q&A Session Summary Question: What does the company hope to see in RESOLVE AD to move forward into Phase III? - The company aims to replicate Phase I data and compare results against Dupixent as a benchmark for efficacy [35] Question: What are the expectations for the placebo response in RESOLVE AD? - The company anticipates a lower placebo response than the 47% observed in Phase I, due to proactive measures taken in the study design [37] Question: How many patients have progressed to the maintenance portion of the trial? - The company cannot disclose specific numbers at this time but will provide details in the upcoming top-line results [40] Question: What is the dropout rate for the Phase 1b atopic dermatitis trial? - The dropout rate was approximately 30% for placebo and in the low to mid-20s for Respag arms, with similar reporting expected for the Phase II results [50][51] Question: Will the company pursue an end of Phase II meeting with the FDA after the 36-week AD data? - The company plans to initiate discussions with the FDA based on the 16-week induction data, without waiting for the completion of the maintenance phase [88]
Nektar(NKTR) - 2025 Q1 - Earnings Call Transcript
2025-05-08 22:02
Financial Data and Key Metrics Changes - The company ended Q1 2025 with $220.7 million in cash and investments, with no debt on the balance sheet, and expects a cash runway extending into Q4 2026 [27] - Q1 2025 revenue was $10.5 million, primarily from non-cash royalty revenue, with expectations to maintain similar quarterly revenue levels for the remainder of 2025, totaling approximately $40 million for the full year [27][28] - R&D expenses for Q1 2025 were $30.5 million, with full-year expectations ranging between $110 million and $120 million [28] - The net loss for Q1 was $50.9 million, equating to a net loss per share of $0.24 [31] Business Line Data and Key Metrics Changes - The company is focusing on the development of its immunology pipeline, particularly the advancement of Respag (Rezpeg) in three Phase II studies [6][10] - The Phase 2b study for atopic dermatitis (Resolve AD) aims to establish a dose for Phase III studies, with top-line results expected in June 2025 [8][14] - The company is also advancing NKTR-165, a TNFR2 antagonist antibody, through IND enabling studies, with plans for an IND filing in 2025 [13][24] Market Data and Key Metrics Changes - There are approximately 30 million adult patients with atopic dermatitis in the US, with a significant unmet need for new treatment mechanisms [9] - The company estimates that about 8% of patients with moderate to severe atopic dermatitis are currently treated with biologics, primarily Dupixent, but many do not benefit or become refractory [10] Company Strategy and Development Direction - The company aims to differentiate Respag from existing therapies by targeting underlying disease pathology rather than just controlling symptoms [10] - The strategy includes exploring partnerships for Phase III studies due to the financial position of the company, while retaining significant ownership of the drug [57] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Respag to address significant unmet needs in chronic conditions, particularly in atopic dermatitis and alopecia areata [6][10] - The company plans to maintain momentum in its development programs and is preparing for an end-of-phase two meeting with the FDA based on upcoming data [87] Other Important Information - The company recorded a non-cash loss from equity method investment of $4.5 million in Q1 2025, with expectations of a total loss of approximately $10 million for the full year [30] - The company is entering a quiet period until the top-line results for the Respag atopic dermatitis study are reported in June [31] Q&A Session Summary Question: What does the company hope to see in RESOLVE AD to move forward into Phase III? - The company aims to replicate Phase I data and achieve efficacy benchmarks comparable to Dupixent [35] Question: What are the expectations for the placebo response in RESOLVE AD? - The company anticipates a lower placebo response than the 47% observed in Phase I, due to proactive measures taken in the study design [37] Question: How many patients have progressed to the maintenance portion of the trial? - The company cannot disclose specific numbers at this time but will provide details in the upcoming top-line results [40] Question: What is the dropout rate for the Phase 1b atopic dermatitis trial? - The dropout rate was approximately 30% for placebo and in the low to mid-20s for Respag arms [50] Question: Will the company seek partnerships after Phase II or take Respag into Phase III independently? - The company is likely to seek partnerships to support the Phase III program while retaining significant ownership of the drug [57]
Nektar(NKTR) - 2025 Q1 - Quarterly Report
2025-05-08 22:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 0-24006 NEKTAR THERAPEUTICS (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpor ...
Nektar(NKTR) - 2025 Q1 - Earnings Call Transcript
2025-05-08 22:00
Financial Data and Key Metrics Changes - The company ended Q1 2025 with $220.7 million in cash and investments, with no debt on the balance sheet, and expects a cash runway extending into Q4 2026 [26] - Q1 2025 revenue was $10.5 million, primarily from non-cash royalty revenue, with expectations to maintain similar revenue levels for the remainder of 2025, totaling approximately $40 million for the full year [26][27] - R&D expenses for Q1 2025 were $30.5 million, with full-year expectations ranging between $110 million and $120 million [27] - The net loss for Q1 was $50.9 million, equating to a net loss per share of $0.24 [30] Business Line Data and Key Metrics Changes - The company is focusing on the development of its immunology pipeline, particularly the advancement of Respag (Rezpeg) in three Phase II studies [5][6] - The Phase 2b study for atopic dermatitis (Resolve AD) aims to demonstrate efficacy and safety, with top-line results expected in June 2025 [6][12] - The company is also advancing NKTR-165, a TNFR2 antagonist antibody, through IND enabling studies, with plans for an IND filing in 2025 [11][24] Market Data and Key Metrics Changes - There are approximately 30 million adult patients with atopic dermatitis in the US, with a significant unmet need for new treatment mechanisms [7] - About 8% of patients with moderate to severe atopic dermatitis are currently treated with biologics, primarily Dupixent, but many do not benefit or become refractory [8] Company Strategy and Development Direction - The company aims to establish Rezpeg as a first-in-class T regulatory cell therapy for various immune disorders, differentiating it from existing biologics by targeting underlying disease pathology [8][10] - The strategy includes exploring partnerships for Phase III studies due to the financial position of the company, while retaining significant ownership of the drug [56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Rezpeg to address high unmet needs in chronic conditions like atopic dermatitis and alopecia areata [5][10] - The company plans to maintain momentum in its development programs and is preparing for an end-of-phase two meeting with the FDA based on upcoming data [85] Other Important Information - The company recorded a non-cash loss from equity method investment of $4.5 million in Q1 2025, with expectations of a total loss of approximately $10 million for the full year [29] - The company is entering a quiet period in June 2025 until the top-line results for the Respeg atopic dermatitis study are reported [31] Q&A Session Summary Question: What does the company hope to see in RESOLVE AD to move forward into Phase III? - The company aims to replicate Phase I data and achieve efficacy comparable to Dupixent, ideally identifying one dose level for Phase III [34][35] Question: What are the expectations for the placebo response in RESOLVE AD? - The company anticipates a lower placebo response rate than the 47% observed in Phase 1b, having taken measures to control this in the current study [36] Question: Can the company disclose how many patients have progressed to the maintenance portion of the trial? - The company cannot disclose that information at this time but will provide details in the upcoming top-line results [40] Question: What is the dropout rate for the Phase 1b atopic dermatitis trial? - The dropout rate was approximately 30% for placebo and in the low to mid-20s for Respeg arms, with plans to report dropout rates in the upcoming results [50][51] Question: Will the company pursue an end-of-phase two meeting with the FDA after the 36-week AD data? - The company plans to initiate discussions with the FDA based on the top-line data from the upcoming study, without waiting for the completion of the maintenance phase [85]
Nektar(NKTR) - 2025 Q1 - Quarterly Results
2025-05-08 20:20
Exhibit 99.1 Nektar Therapeutics Reports First Quarter 2025 Financial Results SAN FRANCISCO, May 8, 2025 -- Nektar Therapeutics (Nasdaq: NKTR) today reported financial results for the first quarter ended March 31, 2025. Cash and investments in marketable securities on March 31, 2025 were $220.7 million as compared to $269.1 million on December 31, 2024. Nektar's cash and marketable securities are expected to support strategic development activities and operations into the fourth quarter of 2026. "We are on ...
Will Nektar Therapeutics (NKTR) Report Negative Q1 Earnings? What You Should Know
ZACKS· 2025-05-01 15:06
Wall Street expects a year-over-year increase in earnings on lower revenues when Nektar Therapeutics (NKTR) reports results for the quarter ended March 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the ...